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Sign in to subscribeDiphenhydramine Hydrochloride Injection
Matched- Active ingredients (original)
- DIPHENHYDRAMINE HYDROCHLORIDE
- Dosage form (original)
- INJECTABLE
- Route (original)
- INJECTION
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 approvalApproved before 1982
ANDA applications18
RLD applicantMCNEIL CONSUMER HEALTHCARE / WEST-WARD PHARMACEUTICALS INTERNATIONAL LTD
Currently marketed products: 8 · 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 |
|---|---|---|---|---|---|---|---|---|---|
| A040140-001 | DIPHENHYDRAMINE HYDROCHLORIDE | HOSPIRA INC | INJECTABLE | INJECTION | DIPHENHYDRAMINE HYDROCHLORIDE: 50MG/ML | 1998/11/20 | N / N | DISCONTINUED | openFDA ↗ |
| A040466-001 | DIPHENHYDRAMINE HYDROCHLORIDE | APP PHARMACEUTICALS LLC | INJECTABLE | INJECTION | DIPHENHYDRAMINE HYDROCHLORIDE: 50MG/ML | 2002/05/28 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A040498-001 | DIPHENHYDRAMINE HYDROCHLORIDE | PHARMOBEDIENT CONSULTING LLC | INJECTABLE | INJECTION | DIPHENHYDRAMINE HYDROCHLORIDE: 50MG/ML | 2005/07/12 | N / N | DISCONTINUED | openFDA ↗ |
| A080577-001 | DIPHENHYDRAMINE HYDROCHLORIDE | WYETH AYERST LABORATORIES | INJECTABLE | INJECTION | DIPHENHYDRAMINE HYDROCHLORIDE: 50MG/ML | Approved before 1982 | N / N | DISCONTINUED | openFDA ↗ |
| A080586-002 | DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE | ABRAXIS PHARMACEUTICAL PRODUCTS | INJECTABLE | INJECTION | DIPHENHYDRAMINE HYDROCHLORIDE: 50MG/ML | Approved before 1982 | N / N | DISCONTINUED | openFDA ↗ |
| A080817-002 | DIPHENHYDRAMINE HYDROCHLORIDE | WEST-WARD PHARMACEUTICALS INTERNATIONAL LTD | INJECTABLE | INJECTION | DIPHENHYDRAMINE HYDROCHLORIDE: 50MG/ML | Approved before 1982 | Y / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A080822-001 | DIPHENHYDRAMINE HYDROCHLORIDE | BEL MAR LABORATORIES INC | INJECTABLE | INJECTION | DIPHENHYDRAMINE HYDROCHLORIDE: 10MG/ML | Approved before 1982 | N / N | DISCONTINUED | openFDA ↗ |
| A080873-001 | DIPHENHYDRAMINE HYDROCHLORIDE | DR REDDYS LABORATORIES LTD | INJECTABLE | INJECTION | DIPHENHYDRAMINE HYDROCHLORIDE: 10MG/ML | Approved before 1982 | N / N | DISCONTINUED | openFDA ↗ |
| A080873-002 | DIPHENHYDRAMINE HYDROCHLORIDE | DR REDDYS LABORATORIES LTD | INJECTABLE | INJECTION | DIPHENHYDRAMINE HYDROCHLORIDE: 50MG/ML | Approved before 1982 | N / N | DISCONTINUED | openFDA ↗ |
| A080873-003 | DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE | DR REDDYS LABORATORIES LTD | INJECTABLE | INJECTION | DIPHENHYDRAMINE HYDROCHLORIDE: 50MG/ML | Approved before 1982 | N / N | DISCONTINUED | openFDA ↗ |
| A083183-001 | DIPHENHYDRAMINE HYDROCHLORIDE | HIKMA PHARMACEUTICALS USA INC | INJECTABLE | INJECTION | DIPHENHYDRAMINE HYDROCHLORIDE: 50MG/ML | Approved before 1982 | N / N | DISCONTINUED | openFDA ↗ |
| A083533-001 | DIPHENHYDRAMINE HYDROCHLORIDE | WATSON LABORATORIES INC | INJECTABLE | INJECTION | DIPHENHYDRAMINE HYDROCHLORIDE: 10MG/ML | Approved before 1982 | N / N | DISCONTINUED | openFDA ↗ |
| A084094-001 | DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE | INTERNATIONAL MEDICATION SYSTEM | INJECTABLE | INJECTION | DIPHENHYDRAMINE HYDROCHLORIDE: 50MG/ML | Approved before 1982 | N / N | DISCONTINUED | openFDA ↗ |
| A087066-001 | DIPHENHYDRAMINE HYDROCHLORIDE | LYPHOMED DIV FUJISAWA USA INC | INJECTABLE | INJECTION | DIPHENHYDRAMINE HYDROCHLORIDE: 10MG/ML | Approved before 1982 | N / N | DISCONTINUED | openFDA ↗ |
| A091526-001 | DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE | FRESENIUS KABI USA LLC | INJECTABLE | INJECTION | DIPHENHYDRAMINE HYDROCHLORIDE: 50MG/ML | 2013/03/26 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A205336-001 | DIPHENHYDRAMINE HYDROCHLORIDE | AVET LIFESCIENCES PRIVATE LTD | INJECTABLE | INJECTION | DIPHENHYDRAMINE HYDROCHLORIDE: 50MG/ML | 2025/06/24 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A205337-001 | DIPHENHYDRAMINE HYDROCHLORIDE | AVET LIFESCIENCES PRIVATE LTD | INJECTABLE | INJECTION | DIPHENHYDRAMINE HYDROCHLORIDE: 50MG/ML | 2025/11/14 | N / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A205723-001 | DIPHENHYDRAMINE HYDROCHLORIDE | MICRO LABS LTD | INJECTABLE | INJECTION | DIPHENHYDRAMINE HYDROCHLORIDE: 50MG/ML | 2018/08/22 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A218448-001 | DIPHENHYDRAMINE HYDROCHLORIDE | GLAND PHARMA LTD | INJECTABLE | INJECTION | DIPHENHYDRAMINE HYDROCHLORIDE: 50MG/ML | 2024/03/20 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A219845-001 | DIPHENHYDRAMINE HYDROCHLORIDE | MICRO LABS LTD | INJECTABLE | INJECTION | DIPHENHYDRAMINE HYDROCHLORIDE: 50MG/ML | 2025/08/22 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N006146-001 | BENADRYL | MCNEIL CONSUMER HEALTHCARE | INJECTABLE | INJECTION | DIPHENHYDRAMINE HYDROCHLORIDE: 10MG/ML | Approved before 1982 | N / N | DISCONTINUED | openFDA ↗ |
| N006146-002 | BENADRYL | MCNEIL CONSUMER HEALTHCARE | INJECTABLE | INJECTION | DIPHENHYDRAMINE HYDROCHLORIDE: 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Approved before 1982 | Y / N | DISCONTINUED | openFDA ↗ |
| N009486-001 | BENADRYL PRESERVATIVE FREE | MCNEIL CONSUMER HEALTHCARE | INJECTABLE | INJECTION | DIPHENHYDRAMINE HYDROCHLORIDE: 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Approved before 1982 | 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 3
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Shandong Zhi Tai Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202630321ml: 50mg | 2026/01/05 | Official source ↗ |
| Sui Cheng Pharma Co., Ltd. romanized | 国药准字H202582530.4ml：20mg | 2025/11/20 | Official source ↗ |
| Sui Cheng Pharma Co., Ltd. romanized | 国药准字H202582541ml：50mg | 2025/11/20 | Official source ↗ |
| Shanghai Zhao Hui Pharma Co., Ltd. romanized | 国药准字H202581391ml：50mg | 2025/07/24 | Official source ↗ |
NHSA approval numbers 20
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Beijing Shi Yong Kang Pharma Co., Ltd. romanized | 国药准字H110205231ml:20mg | — | Official source ↗ |
| Guangdong Bang Min Pharmaceutical Factory Co., Ltd. romanized | 国药准字H440219061ml:20mg | — | Official source ↗ |
| Guangzhou Bai Yun Shan Ming Xing Pharmaceutical Co., Ltd. romanized | 国药准字H440223871ml:20mg | — | Official source ↗ |
| Shanghai Zhao Hui Pharma Co., Ltd. romanized | 国药准字H310210871ml:20mg | — | Official source ↗ |
| Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized | 国药准字H120206171ml:20mg | — | Official source ↗ |
| Xi Nan Pharma Co., Ltd. romanized | 国药准字H500201441ml:20mg | — | Official source ↗ |
| Ya Bang Pharmaceuticals Co., Ltd. romanized | 国药准字H320214351ml:20mg | — | Official source ↗ |
| Hubei Ke Lun Pharma Co., Ltd. romanized | 国药准字H420211751ml:20mg | — | Official source ↗ |
| Xian Li Jun Pharmaceutical Co., Ltd. romanized | 国药准字H610216791ml:20mg | — | Official source ↗ |
| Hebei Wan Cheng Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H130214431ml:20mg | — | Official source ↗ |
| Topfond Pharmaceutical Co., Ltd. | 国药准字H410203541ml:20mg | — | Official source ↗ |
| Kai Feng Pharmaceutical (Group) Co., Ltd. romanized | 国药准字H410217921ml:20mg | — | Official source ↗ |
| Sui Cheng Pharma Co., Ltd. romanized | 国药准字H410212641ml:20mg | — | Official source ↗ |
| Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized | 国药准字H410202251ml:20mg | — | Official source ↗ |
| Zhong Jia Bio Technology (Hubei Sheng) Co., Ltd. romanized | 国药准字H200539261ml:20mg | — | Official source ↗ |
| Fujian Gu Tian Pharma Co., Ltd. romanized | 国药准字H350201061ml:20mg | — | Official source ↗ |
| Shanghai Zhao Hui Pharma Co., Ltd. romanized | 国药准字H202581391ml:50mg | — | Official source ↗ |
| Shandong Zhi Tai Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202630321ml:50mg | — | Official source ↗ |
| Beijing Shi Yong Kang Pharma Co., Ltd. romanized | 国药准字H110205231ml:20mg | — | Official source ↗ |
| Guangzhou Bai Yun Shan Ming Xing Pharmaceutical Co., Ltd. romanized | 国药准字H440223871ml:20mg | — | Official source ↗ |
| Shanghai Zhao Hui Pharma Co., Ltd. romanized | 国药准字H310210871ml:20mg | — | Official source ↗ |
| Jin Yao He Ping (Tianjin) Pharmaceutical Co., Ltd. romanized | 国药准字H120206171ml:20mg | — | Official source ↗ |
| Xi Nan Pharma Co., Ltd. romanized | 国药准字H500201441ml:20mg | — | Official source ↗ |
| Ya Bang Pharmaceuticals Co., Ltd. romanized | 国药准字H320214351ml:20mg | — | Official source ↗ |
| Hubei Ke Lun Pharma Co., Ltd. romanized | 国药准字H420211751ml:20mg | — | Official source ↗ |
| Xian Li Jun Pharmaceutical Co., Ltd. romanized | 国药准字H610216791ml:20mg | — | Official source ↗ |
| Hebei Wan Cheng Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H130214431ml:20mg | — | Official source ↗ |
| Topfond Pharmaceutical Co., Ltd. | 国药准字H410203541ml:20mg | — | Official source ↗ |
| Sui Cheng Pharma Co., Ltd. romanized | 国药准字H410212641ml:20mg | — | Official source ↗ |
| Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized | 国药准字H410202251ml:20mg | — | Official source ↗ |
| Shanghai Zhao Hui Pharma Co., Ltd. romanized | 国药准字H202581391ml:50mg | — | Official source ↗ |
| Shandong Zhi Tai Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H202630321ml:50mg | — | Official source ↗ |
| Sui Cheng Pharma Co., Ltd. romanized | 国药准字H202582530.4ml:20mg | — | Official source ↗ |
| Kai Feng Pharmaceutical (Group) Co., Ltd. romanized | 国药准字H410217921ml:20mg | — | Official source ↗ |
| Sui Cheng Pharma Co., Ltd. romanized | 国药准字H202582530.4ml:20mg | — | Official source ↗ |
| Sui Cheng Pharma Co., Ltd. romanized | 国药准字H202582541ml:50mg | — | Official source ↗ |
| Sui Cheng Pharma Co., Ltd. romanized | 国药准字H202582541ml:50mg | — | Official source ↗ |
Under review 9
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized | CYHS2600837 | 2026/04/11 | Official source ↗ |
| Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized | CYHS2600836 | 2026/04/11 | Official source ↗ |
| Anhui Wei Er Man Pharmaceutical Co., Ltd. romanized | CYHS2601497 | 2026/06/25 | Official source ↗ |
| Wuhan Bin Hu Shuang He Pharma Co., Ltd. romanized; Wuhan Fu Xing Bio Pharma Co., Ltd. romanized | CYHB2650133 | 2026/06/10 | Official source ↗ |
| Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized | CYHB2650036 | 2026/01/31 | Official source ↗ |
| Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized | CYHB2650035 | 2026/01/31 | Official source ↗ |
| Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized | CYHB2650034 | 2026/01/31 | Official source ↗ |
| Guangzhou Rui Er Pharmaceuticals Technology Co., Ltd. romanized; E Mei Shan Tong Hui Pharmaceutical Co., Ltd. romanized | CYHS2503744 | 2025/10/21 | Official source ↗ |
| Sichuan Tian Xing Hui Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Bai Yu Pharmaceutical Co., Ltd. romanized | CYHS2503453 | 2025/09/18 | Official source ↗ |
Generic-filing companies this year 2
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized | CYHS2600837 | 2026/04/11 | Official source ↗ |
| Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized | CYHS2600836 | 2026/04/11 | Official source ↗ |
| Anhui Wei Er Man Pharmaceutical Co., Ltd. romanized | CYHS2601497 | 2026/06/25 | Official source ↗ |
API companies with A status 18
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Jin Hong Pharma Co., Ltd. romanized | Y20240000477 | 2025/09/30 | Official source ↗ |
| Yun Peng Pharmaceuticals Group Co., Ltd. romanized | Y20240000441 | 2026/01/22 | Official source ↗ |
| Changchun Hai Yue Pharma Co., Ltd. romanized | Y20240000223 | 2026/09/29 | Official source ↗ |
| Anhui Heng Xing Pharmaceutical Co., Ltd. romanized | Y20230001131 | 2026/11/10 | Official source ↗ |
| Sichuan Sheng Yu Xin Pharma Co., Ltd. romanized | Y20230000805 | 2026/06/27 | Official source ↗ |
| Bai Yun Shandong Tai Shang Qiu Pharma Co., Ltd. romanized | Y20230000405 | 2026/01/23 | Official source ↗ |
| Supriya Lifescience Ltd. | Y20210001163 | 2025/09/28 | Official source ↗ |
| Jilin Sheng Bo Da Wei Ye Pharmaceutical Co., Ltd. romanized | Y20230000277 | 2024/10/29 | Official source ↗ |
| Zhi En Bio Technology Co., Ltd. romanized | Y20220001232 | 2026/02/26 | Official source ↗ |
| Anhui Wei Er Man Pharmaceutical Co., Ltd. romanized | Y20210000548 | 2023/09/15 | Official source ↗ |
| Wanbury Limited | Y20200000355 | 2026/06/13 | Official source ↗ |
| Shanghai Zhao Hui Pharma Co., Ltd. romanized | Y20190007179 | 2023/03/24 | Official source ↗ |
| Shanghai Shang Yao Xin Ya Pharma Co., Ltd. romanized | Y20190007095 | 2023/03/24 | Official source ↗ |
| Qi Dong Dong Yue Pharma Co., Ltd. romanized | Y20190006273 | 2026/01/08 | Official source ↗ |
| Liao Yuan Shi Di Kang Pharma Co., Ltd. romanized | Y20190005518 | 2025/05/07 | Official source ↗ |
| Hua Run Shuang He Pharma Co., Ltd. romanized | Y20190005444 | — | Official source ↗ |
| Beijing Tai Yang Pharma Co., Ltd. romanized | Y20190004759 | 2025/04/23 | Official source ↗ |
| Liao Yuan Shi Bai Kang Pharma Co., Ltd. romanized | Y20190002144 | 2025/03/22 | 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.
Formulation crosswalk to INJECTABLE / INJECTION, based on the Chinese Pharmacopoeia general formulation provisions, rule CHP-FORM-076. Chinese Pharmacopoeia general chapter 0102
Comparison generated: 2026/11/13 18:41 · openFDA Orange Book ↗
Name and dosage-form matching sources
- NMPA reference-product directory, Shaanxi MPA republication ↗ · 49-17 · 2021/12/15
- Chinese Pharmacopoeia 2025, formulation chapter; site crosswalk ↗ · See source
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