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Sign in to subscribeOndansetron Hydrochloride Tablets
Matched- Active ingredients (original)
- ONDANSETRON HYDROCHLORIDE
- Dosage form (original)
- TABLET
- Route (original)
- ORAL
Read these limits
- US patent expiration does not establish Chinese patent expiration. Dates here come from the US Orange Book; Chinese patent status needs separate checking.
- The Orange Book lists holder-submitted patents and does not cover all related patents.
- “Unmatched” means no English ingredient-name counterpart in the Chinese official-name sources loaded here; it does not mean no Chinese approval or filing. A zero count means a Chinese name is matched but no records were found in the loaded source. Source dates appear below.
- This page contains no sales or market-size data and cannot establish development value.
- Names on unmatched rows are the original FDA Orange Book names, without Chinese translation. The same ingredient may have a different generic name in China.
US-approved products
Application numbers, product numbers and original fields are retained. Marketing status is shown as listed in the source.
Earliest approval1992/12/31
ANDA applications14
RLD applicantSANDOZ INC
Currently marketed products: 13 · Counts FDA prescription and OTC marketing categories as listed; discontinued or unknown categories are excluded.
| Application / product number | Brand name (original) | Applicant (original) | Dosage form (original) | Route (original) | Strength (original) | Earliest approval | RLD / RS | Marketing status (original) | Official source |
|---|---|---|---|---|---|---|---|---|---|
| A076183-001 | ONDANSETRON HYDROCHLORIDE | DR REDDYS LABORATORIES LTD | TABLET | ORAL | ONDANSETRON HYDROCHLORIDE: EQ 24MG BASE | 2006/12/26 | N / N | DISCONTINUED | openFDA ↗ |
| A076183-002 | ONDANSETRON HYDROCHLORIDE | DR REDDYS LABORATORIES LTD | TABLET | ORAL | ONDANSETRON HYDROCHLORIDE: EQ 8MG BASE | 2006/12/26 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A076183-003 | ONDANSETRON HYDROCHLORIDE | DR REDDYS LABORATORIES LTD | TABLET | ORAL | ONDANSETRON HYDROCHLORIDE: EQ 4MG BASE | 2006/12/26 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A076183-004 | ONDANSETRON HYDROCHLORIDE | DR REDDYS LABORATORIES LTD | TABLET | ORAL | ONDANSETRON HYDROCHLORIDE: EQ 16MG BASE | 2006/12/26 | N / N | DISCONTINUED | openFDA ↗ |
| A076252-001 | ONDANSETRON HYDROCHLORIDE | TEVA PHARMACEUTICALS USA INC | TABLET | ORAL | ONDANSETRON HYDROCHLORIDE: EQ 4MG BASE | 2007/06/25 | N / N | DISCONTINUED | openFDA ↗ |
| A076252-002 | ONDANSETRON HYDROCHLORIDE | TEVA PHARMACEUTICALS USA INC | TABLET | ORAL | ONDANSETRON HYDROCHLORIDE: EQ 8MG BASE | 2007/06/25 | N / N | DISCONTINUED | openFDA ↗ |
| A076252-003 | ONDANSETRON HYDROCHLORIDE | TEVA PHARMACEUTICALS USA INC | TABLET | ORAL | ONDANSETRON HYDROCHLORIDE: EQ 24MG BASE | 2007/06/25 | N / N | DISCONTINUED | openFDA ↗ |
| A076930-001 | ONDANSETRON HYDROCHLORIDE | RISING PHARMA HOLDINGS INC | TABLET | ORAL | ONDANSETRON HYDROCHLORIDE: EQ 4MG BASE | 2007/06/25 | N / N | DISCONTINUED | openFDA ↗ |
| A076930-002 | ONDANSETRON HYDROCHLORIDE | RISING PHARMA HOLDINGS INC | TABLET | ORAL | ONDANSETRON HYDROCHLORIDE: EQ 8MG BASE | 2007/06/25 | N / N | DISCONTINUED | openFDA ↗ |
| A076930-004 | ONDANSETRON HYDROCHLORIDE | RISING PHARMA HOLDINGS INC | TABLET | ORAL | ONDANSETRON HYDROCHLORIDE: EQ 24MG BASE | 2007/06/25 | N / N | DISCONTINUED | openFDA ↗ |
| A077050-001 | ONDANSETRON HYDROCHLORIDE | SUN PHARMACEUTICAL INDUSTRIES LTD | TABLET | ORAL | ONDANSETRON HYDROCHLORIDE: EQ 4MG BASE | 2007/06/25 | N / N | DISCONTINUED | openFDA ↗ |
| A077050-002 | ONDANSETRON HYDROCHLORIDE | SUN PHARMACEUTICAL INDUSTRIES LTD | TABLET | ORAL | ONDANSETRON HYDROCHLORIDE: EQ 8MG BASE | 2007/06/25 | N / N | DISCONTINUED | openFDA ↗ |
| A077112-001 | ONDANSETRON HYDROCHLORIDE | PLIVA HRVATSKA DOO | TABLET | ORAL | ONDANSETRON HYDROCHLORIDE: EQ 4MG BASE | 2007/06/25 | N / N | DISCONTINUED | openFDA ↗ |
| A077112-002 | ONDANSETRON HYDROCHLORIDE | PLIVA HRVATSKA DOO | TABLET | ORAL | ONDANSETRON HYDROCHLORIDE: EQ 8MG BASE | 2007/06/25 | N / N | DISCONTINUED | openFDA ↗ |
| A077112-003 | ONDANSETRON HYDROCHLORIDE | PLIVA HRVATSKA DOO | TABLET | ORAL | ONDANSETRON HYDROCHLORIDE: EQ 24MG BASE | 2007/06/25 | N / N | DISCONTINUED | openFDA ↗ |
| A077303-001 | ONDANSETRON HYDROCHLORIDE | CHARTWELL MOLECULES LLC | TABLET | ORAL | ONDANSETRON HYDROCHLORIDE: EQ 4MG BASE | 2007/06/25 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A077303-002 | ONDANSETRON HYDROCHLORIDE | CHARTWELL MOLECULES LLC | TABLET | ORAL | ONDANSETRON HYDROCHLORIDE: EQ 8MG BASE | 2007/06/25 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A077303-004 | ONDANSETRON HYDROCHLORIDE | CHARTWELL MOLECULES LLC | TABLET | ORAL | ONDANSETRON HYDROCHLORIDE: EQ 24MG BASE | 2007/06/25 | N / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A077306-001 | ONDANSETRON HYDROCHLORIDE | APOTEX INC | TABLET | ORAL | ONDANSETRON HYDROCHLORIDE: EQ 4MG BASE | 2007/06/25 | N / N | DISCONTINUED | openFDA ↗ |
| A077306-002 | ONDANSETRON HYDROCHLORIDE | APOTEX INC | TABLET | ORAL | ONDANSETRON HYDROCHLORIDE: EQ 8MG BASE | 2007/06/25 | N / N | DISCONTINUED | openFDA ↗ |
| A077517-001 | ONDANSETRON HYDROCHLORIDE | CHARTWELL RX SCIENCES LLC | TABLET | ORAL | ONDANSETRON HYDROCHLORIDE: EQ 4MG BASE | 2007/06/25 | N / N | DISCONTINUED | openFDA ↗ |
| A077517-002 | ONDANSETRON HYDROCHLORIDE | CHARTWELL RX SCIENCES LLC | TABLET | ORAL | ONDANSETRON HYDROCHLORIDE: EQ 8MG BASE | 2007/06/25 | N / N | DISCONTINUED | openFDA ↗ |
| A077517-003 | ONDANSETRON HYDROCHLORIDE | CHARTWELL RX SCIENCES LLC | TABLET | ORAL | ONDANSETRON HYDROCHLORIDE: EQ 24MG BASE | 2007/06/25 | N / N | DISCONTINUED | openFDA ↗ |
| A077535-001 | ONDANSETRON HYDROCHLORIDE | GLENMARK PHARMACEUTICALS LTD | TABLET | ORAL | ONDANSETRON HYDROCHLORIDE: EQ 4MG BASE | 2007/06/25 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A077535-002 | ONDANSETRON HYDROCHLORIDE | GLENMARK PHARMACEUTICALS LTD | TABLET | ORAL | ONDANSETRON HYDROCHLORIDE: EQ 8MG BASE | 2007/06/25 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A077535-003 | ONDANSETRON HYDROCHLORIDE | GLENMARK PHARMACEUTICALS LTD | TABLET | ORAL | ONDANSETRON HYDROCHLORIDE: EQ 24MG BASE | 2007/06/25 | N / N | DISCONTINUED | openFDA ↗ |
| A077545-001 | ONDANSETRON HYDROCHLORIDE | HIKMA PHARMACEUTICALS USA INC | TABLET | ORAL | ONDANSETRON HYDROCHLORIDE: EQ 4MG BASE | 2007/09/06 | N / N | DISCONTINUED | openFDA ↗ |
| A077545-002 | ONDANSETRON HYDROCHLORIDE | HIKMA PHARMACEUTICALS USA INC | TABLET | ORAL | ONDANSETRON HYDROCHLORIDE: EQ 8MG BASE | 2007/09/06 | N / N | DISCONTINUED | openFDA ↗ |
| A077545-003 | ONDANSETRON HYDROCHLORIDE | HIKMA PHARMACEUTICALS USA INC | TABLET | ORAL | ONDANSETRON HYDROCHLORIDE: EQ 24MG BASE | 2007/09/06 | N / N | DISCONTINUED | openFDA ↗ |
| A077729-001 | ONDANSETRON HYDROCHLORIDE | TARO PHARMACEUTICAL INDUSTRIES LTD | TABLET | ORAL | ONDANSETRON HYDROCHLORIDE: EQ 4MG BASE | 2011/03/28 | N / N | DISCONTINUED | openFDA ↗ |
| A077729-002 | ONDANSETRON HYDROCHLORIDE | TARO PHARMACEUTICAL INDUSTRIES LTD | TABLET | ORAL | ONDANSETRON HYDROCHLORIDE: EQ 8MG BASE | 2011/03/28 | N / N | DISCONTINUED | openFDA ↗ |
| A077729-003 | ONDANSETRON HYDROCHLORIDE | TARO PHARMACEUTICAL INDUSTRIES LTD | TABLET | ORAL | ONDANSETRON HYDROCHLORIDE: EQ 24MG BASE | 2011/03/28 | N / N | DISCONTINUED | openFDA ↗ |
| A077851-001 | ONDANSETRON HYDROCHLORIDE | NATCO PHARMA LTD | TABLET | ORAL | ONDANSETRON HYDROCHLORIDE: EQ 4MG BASE | 2007/06/25 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A077851-002 | ONDANSETRON HYDROCHLORIDE | NATCO PHARMA LTD | TABLET | ORAL | ONDANSETRON HYDROCHLORIDE: EQ 8MG BASE | 2007/06/25 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A078539-001 | ONDANSETRON HYDROCHLORIDE | AUROBINDO PHARMA LTD | TABLET | ORAL | ONDANSETRON HYDROCHLORIDE: EQ 4MG BASE | 2007/07/31 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A078539-002 | ONDANSETRON HYDROCHLORIDE | AUROBINDO PHARMA LTD | TABLET | ORAL | ONDANSETRON HYDROCHLORIDE: EQ 8MG BASE | 2007/07/31 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A078539-003 | ONDANSETRON HYDROCHLORIDE | AUROBINDO PHARMA LTD | TABLET | ORAL | ONDANSETRON HYDROCHLORIDE: EQ 24MG BASE | 2007/07/31 | N / N | DISCONTINUED | openFDA ↗ |
| A203761-001 | ONDANSETRON HYDROCHLORIDE | IPCA LABORATORIES LTD | TABLET | ORAL | ONDANSETRON HYDROCHLORIDE: EQ 4MG BASE | 2014/01/23 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A203761-002 | ONDANSETRON HYDROCHLORIDE | IPCA LABORATORIES LTD | TABLET | ORAL | ONDANSETRON HYDROCHLORIDE: EQ 8MG BASE | 2014/01/23 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N020103-001 | ZOFRAN | SANDOZ INC | TABLET | ORAL | ONDANSETRON HYDROCHLORIDE: EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 1992/12/31 | Y / N | DISCONTINUED | openFDA ↗ |
| N020103-002 | ZOFRAN | SANDOZ INC | TABLET | ORAL | ONDANSETRON HYDROCHLORIDE: EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 1992/12/31 | Y / N | DISCONTINUED | openFDA ↗ |
| N020103-003 | ZOFRAN | SANDOZ INC | TABLET | ORAL | ONDANSETRON HYDROCHLORIDE: EQ 24MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 1999/08/27 | Y / N | DISCONTINUED | openFDA ↗ |
Listed US patents
*PED rows, substance/product flags, use codes and delisting-request flags are retained without determining legal effect.
Latest listed patent expiration—
Substance patent expiration (DS flag)—
This column includes only source rows explicitly flagged DS. A PED row without that flag is not assigned one by this site.
| Application / product number | Patent number | Listed expiration | Substance / product flags | Use code | Delisting request | Official source |
|---|---|---|---|---|---|---|
| Not listed | ||||||
Exclusivity source records
FDA exclusivity code list ↗Latest exclusivity expiration: —
| Application / product number | Exclusivity code | Listed expiration | Official source |
|---|---|---|---|
| Not listed | |||
Chinese record details
Chinese product landscape ↗The four-zero filter applies only to matched rows: catalog holders, NHSA approval numbers, applications under review, and companies filing generics this year. Unmatched rows have no Chinese counts. Filings are counted by acceptance number and filing companies by first applicant. Strengths may have separate applications. Drug names are normalized only for width and whitespace; distinct generic names, dosage forms and combinations remain separate. Unstated strengths are marked. Company counts from different sources must not be added together.
Catalog holders 5
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Bei Da Pharmaceuticals Co., Ltd. romanized | 国药准字H10970155See source | 2025/04/11 | Official source ↗ |
| Hangzhou He Ze Kun Yuan Pharma Co., Ltd. romanized | 国药准字H20249199See source | 2024/10/29 | Official source ↗ |
| Hangzhou He Ze Kun Yuan Pharma Co., Ltd. romanized | 国药准字H20249200See source | 2024/10/29 | Official source ↗ |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20234368See source | 2023/10/24 | Official source ↗ |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20234369See source | 2023/10/24 | Official source ↗ |
| Fu An Pharma Group Ningbo Tian Heng Pharmaceutical Co., Ltd. romanized | 国药准字H10960146See source | 2023/02/20 | Official source ↗ |
| Qilu Pharmaceutical Co., Ltd. | 国药准字H10970062See source | 2019/12/10 | Official source ↗ |
| Qilu Pharmaceutical Co., Ltd. | 国药准字H10970063See source | 2019/01/16 | Official source ↗ |
NHSA approval numbers 11
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Chengdu Tong De Pharma Co., Ltd. romanized | 国药准字H20263083See source | — | Official source ↗ |
| Chengdu Tong De Pharma Co., Ltd. romanized | 国药准字H20263083See source | — | Official source ↗ |
| Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H20254887See source | — | Official source ↗ |
| Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized | 国药准字H20254888See source | — | Official source ↗ |
| Bei Da Pharmaceuticals Co., Ltd. romanized | 国药准字H10970155See source | — | Official source ↗ |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20234368See source | — | Official source ↗ |
| Qilu Pharmaceutical Co., Ltd. | 国药准字H10970062See source | — | Official source ↗ |
| Fu An Pharma Group Ningbo Tian Heng Pharmaceutical Co., Ltd. romanized | 国药准字H10960146See source | — | Official source ↗ |
| Zhejiang Hao Ge Pharma Co., Ltd. romanized | 国药准字H20249199See source | — | Official source ↗ |
| Bei Da Pharmaceuticals Co., Ltd. romanized | 国药准字H10970155See source | — | Official source ↗ |
| Fu An Pharma Group Ningbo Tian Heng Pharmaceutical Co., Ltd. romanized | 国药准字H10960146See source | — | Official source ↗ |
| Bei Da Pharmaceuticals Co., Ltd. romanized | 国药准字H10970155See source | — | Official source ↗ |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20234369See source | — | Official source ↗ |
| Zhejiang Hao Ge Pharma Co., Ltd. romanized | 国药准字H20249200See source | — | Official source ↗ |
| Qilu Pharmaceutical Co., Ltd. | 国药准字H10970063See source | — | Official source ↗ |
| Bei Da Pharmaceuticals Co., Ltd. romanized | 国药准字H10970155See source | — | Official source ↗ |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20234368See source | — | Official source ↗ |
| Fu An Pharma Group Ningbo Tian Heng Pharmaceutical Co., Ltd. romanized | 国药准字H10960146See source | — | Official source ↗ |
| Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 国药准字H20234369See source | — | Official source ↗ |
Under review 6
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Nanjing Hai Jing Pharma Co., Ltd. romanized | CYHS2601877 | 2026/08/03 | Official source ↗ |
| Nanjing Hai Jing Pharma Co., Ltd. romanized | CYHS2601876 | 2026/08/03 | Official source ↗ |
| Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized | CYHS2602450 | 2026/10/08 | Official source ↗ |
| Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized | CYHS2602449 | 2026/10/08 | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | CYHS2503243 | 2025/09/02 | Official source ↗ |
| CISEN PHARMACEUTICAL CO., LTD. | CYHS2503242 | 2025/09/02 | Official source ↗ |
Generic-filing companies this year 2
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Nanjing Hai Jing Pharma Co., Ltd. romanized | CYHS2601877 | 2026/08/03 | Official source ↗ |
| Nanjing Hai Jing Pharma Co., Ltd. romanized | CYHS2601876 | 2026/08/03 | Official source ↗ |
| Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized | CYHS2602450 | 2026/10/08 | Official source ↗ |
| Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized | CYHS2602449 | 2026/10/08 | Official source ↗ |
API companies with A status 13
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Sichuan Xin Kai Yuan Pharmaceutical Co., Ltd. romanized | Y20250000593 | 2026/10/16 | Official source ↗ |
| Sichuan Xin Kai Yuan Pharmaceutical Co., Ltd. romanized | Y20230000303 | 2026/06/16 | Official source ↗ |
| Dr. Reddy's Laboratories Ltd. | Y20220001178 | 2025/08/28 | Official source ↗ |
| Lan Xi Ha San Lian Pharmaceutical Co., Ltd. romanized | Y20220000619 | 2025/05/09 | Official source ↗ |
| Apitoria Pharma Private Limited | Y20210000190 | 2025/07/15 | Official source ↗ |
| Natco Pharma Limited | Y20200000836 | 2024/01/31 | Official source ↗ |
| Dr. Reddy's Laboratories Ltd. | Y20200000931 | 2026/05/20 | Official source ↗ |
| Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | Y20190021613 | 2026/08/20 | Official source ↗ |
| Fu An Pharma Group Ningbo Tian Heng Pharmaceutical Co., Ltd. romanized | Y20190009491 | — | Official source ↗ |
| Sichuan Chuan Da Hua Xi Pharma Co., Ltd. romanized | Y20190006261 | — | Official source ↗ |
| Hainan Xian Sheng Pharma Co., Ltd. romanized | Y20190006208 | 2024/06/28 | Official source ↗ |
| Changzhou Ya Bang Pharmaceutical Co., Ltd. romanized | Y20190004948 | 2025/08/30 | Official source ↗ |
| Changzhou Lan Ling Pharmaceutical Co., Ltd. romanized | Y20190003744 | 2025/07/18 | Official source ↗ |
| Bei Da Pharmaceuticals Co., Ltd. romanized | Y20190002237 | 2025/09/01 | Official source ↗ |
| Qilu Pharmaceutical Co., Ltd. | Y20190001571 | 2024/11/21 | Official source ↗ |
| Qilu Pharmaceutical Co., Ltd. | Y20180001049 | 2025/07/18 | Official source ↗ |
| Fu An Pharma Group Ningbo Tian Heng Pharmaceutical Co., Ltd. romanized | Y20170002166 | 2025/01/25 | Official source ↗ |
Trial registrations 2025/2026 —
Not loaded
Sources and dates
- FDA Orange Book
- 2026/11/06
- CDE acceptance and review
- 2026/11/13 06:42
- Chemical Drug Catalog
- 2026/11/13 06:39
- API registration records
- 2026/11/13 06:41
- NHSA drug code database
- 2026/10/23
- Trial registry
- 2026/11/13 08:09 · Incomplete coverage
Chinese counts use complete ingredient, dosage-form and route matches. Unmatched and partial rows show name-source matching only and make no finding about Chinese approvals or filings. Trials cover registration-number years 2025/2026 only.
Comparison generated: 2026/11/13 18:41 · openFDA Orange Book ↗
Name and dosage-form matching sources
- NMPA reference-product directory, Shaanxi MPA republication ↗ · 41-54 · 2021/05/18
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