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Sign in to subscribeSodium Nitroprusside Injection
Matched- Active ingredients (original)
- SODIUM NITROPRUSSIDE
- 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 applications24
RLD applicantABBVIE INC / BAXTER HEALTHCARE CORP ANESTHESIA AND CRITICAL CARE
Currently marketed products: 10 · 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 |
|---|---|---|---|---|---|---|---|---|---|
| A070031-001 | SODIUM NITROPRUSSIDE | ABRAXIS PHARMACEUTICAL PRODUCTS | INJECTABLE | INJECTION | SODIUM NITROPRUSSIDE: 50MG/VIAL | 1985/01/17 | N / N | DISCONTINUED | openFDA ↗ |
| A070566-001 | NITROPRESS | HOSPIRA INC | INJECTABLE | INJECTION | SODIUM NITROPRUSSIDE: 50MG/VIAL | 1986/06/09 | N / N | DISCONTINUED | openFDA ↗ |
| A071555-001 | NITROPRESS | ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV | INJECTABLE | INJECTION | SODIUM NITROPRUSSIDE: 50MG/VIAL | 1987/11/16 | N / N | DISCONTINUED | openFDA ↗ |
| A071961-001 | NITROPRESS | VALEANT PHARMACEUTICALS NORTH AMERICA | INJECTABLE | INJECTION | SODIUM NITROPRUSSIDE: 25MG/ML | 1988/08/01 | N / N | DISCONTINUED | openFDA ↗ |
| A073465-001 | SODIUM NITROPRUSSIDE | TEVA PARENTERAL MEDICINES INC | INJECTABLE | INJECTION | SODIUM NITROPRUSSIDE: 25MG/ML | 1992/03/30 | N / N | DISCONTINUED | openFDA ↗ |
| A207426-001 | SODIUM NITROPRUSSIDE | SAGENT PHARMACEUTICALS INC | INJECTABLE | INJECTION | SODIUM NITROPRUSSIDE: 25MG/ML | 2016/12/08 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A207499-001 | SODIUM NITROPRUSSIDE | NEXUS PHARMACEUTICALS LLC | INJECTABLE | INJECTION | SODIUM NITROPRUSSIDE: 25MG/ML | 2017/05/25 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A208635-001 | SODIUM NITROPRUSSIDE | EPIC PHARMA LLC | INJECTABLE | INJECTION | SODIUM NITROPRUSSIDE: 25MG/ML | 2017/05/04 | N / N | DISCONTINUED | openFDA ↗ |
| A208923-001 | SODIUM NITROPRUSSIDE | AVET LIFESCIENCES PRIVATE LTD | INJECTABLE | INJECTION | SODIUM NITROPRUSSIDE: 25MG/ML | 2022/11/08 | N / N | DISCONTINUED | openFDA ↗ |
| A209352-001 | SODIUM NITROPRUSSIDE | MICRO LABS LTD | INJECTABLE | INJECTION | SODIUM NITROPRUSSIDE: 25MG/ML | 2017/12/08 | N / Y | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A209493-001 | SODIUM NITROPRUSSIDE | AMNEAL EU LTD | INJECTABLE | INJECTION | SODIUM NITROPRUSSIDE: 25MG/ML | 2017/11/07 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A209584-001 | SODIUM NITROPRUSSIDE | PHARMOBEDIENT CONSULTING LLC | INJECTABLE | INJECTION | SODIUM NITROPRUSSIDE: 25MG/ML | 2018/08/10 | N / N | DISCONTINUED | openFDA ↗ |
| A209832-001 | SODIUM NITROPRUSSIDE | AMPHASTAR PHARMACEUTICALS INC | INJECTABLE | INJECTION | SODIUM NITROPRUSSIDE: 25MG/ML | 2017/12/18 | N / N | DISCONTINUED | openFDA ↗ |
| A209834-001 | SODIUM NITROPRUSSIDE | CHARTWELL RX SCIENCES LLC | INJECTABLE | INJECTION | SODIUM NITROPRUSSIDE: 25MG/ML | 2018/06/26 | N / N | DISCONTINUED | openFDA ↗ |
| A210114-001 | SODIUM NITROPRUSSIDE | DR REDDYS LABORATORIES LTD | INJECTABLE | INJECTION | SODIUM NITROPRUSSIDE: 25MG/ML | 2019/04/10 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A210467-001 | SODIUM NITROPRUSSIDE | SUN PHARMACEUTICAL INDUSTRIES LTD | INJECTABLE | INJECTION | SODIUM NITROPRUSSIDE: 25MG/ML | 2018/11/26 | N / N | DISCONTINUED | openFDA ↗ |
| A210763-001 | SODIUM NITROPRUSSIDE | MYLAN LABORATORIES LTD | INJECTABLE | INJECTION | SODIUM NITROPRUSSIDE: 25MG/ML | 2018/04/17 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A210855-001 | SODIUM NITROPRUSSIDE | CIPLA LTD | INJECTABLE | INJECTION | SODIUM NITROPRUSSIDE: 25MG/ML | 2018/07/16 | N / N | DISCONTINUED | openFDA ↗ |
| A210882-001 | SODIUM NITROPRUSSIDE | SOMERSET THERAPEUTICS LLC | INJECTABLE | INJECTION | SODIUM NITROPRUSSIDE: 25MG/ML | 2018/08/17 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211016-001 | SODIUM NITROPRUSSIDE | CAPLIN STERILES LTD | INJECTABLE | INJECTION | SODIUM NITROPRUSSIDE: 25MG/ML | 2019/11/29 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A211277-001 | SODIUM NITROPRUSSIDE | XIROMED PHARMA ESPANA SL | INJECTABLE | INJECTION | SODIUM NITROPRUSSIDE: 25MG/ML | 2020/10/29 | N / N | DISCONTINUED | openFDA ↗ |
| A211934-001 | SODIUM NITROPRUSSIDE | EUGIA PHARMA SPECIALITIES LTD | INJECTABLE | INJECTION | SODIUM NITROPRUSSIDE: 25MG/ML | 2020/12/10 | N / N | DISCONTINUED | openFDA ↗ |
| A214199-001 | SODIUM NITROPRUSSIDE | HAINAN POLY PHARM CO LTD | INJECTABLE | INJECTION | SODIUM NITROPRUSSIDE: 25MG/ML | 2020/08/25 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| A214971-001 | SODIUM NITROPRUSSIDE | BE PHARMACEUTICALS AG | INJECTABLE | INJECTION | SODIUM NITROPRUSSIDE: 25MG/ML | 2021/07/12 | N / N | HUMAN PRESCRIPTION DRUG | openFDA ↗ |
| N017546-001 | NIPRIDE | HOFFMANN LA ROCHE INC | INJECTABLE | INJECTION | SODIUM NITROPRUSSIDE: 50MG/VIAL | Approved before 1982 | N / N | DISCONTINUED | openFDA ↗ |
| N018450-001 | NITROPRESS | ABBVIE INC | INJECTABLE | INJECTION | SODIUM NITROPRUSSIDE: 50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | Approved before 1982 | Y / N | DISCONTINUED | openFDA ↗ |
| N018581-001 | SODIUM NITROPRUSSIDE | BAXTER HEALTHCARE CORP ANESTHESIA AND CRITICAL CARE | INJECTABLE | INJECTION | SODIUM NITROPRUSSIDE: 50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 1982/07/28 | 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 12
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Dr. Reddy’s Laboratories Limited | 国药准字HJ20260086See source | 2026/09/29 | Official source ↗ |
| Caplin Steriles Limited | 国药准字HJ20260085See source | 2026/09/22 | Official source ↗ |
| Shandong Qidu Pharmaceutical Co., Ltd. | 国药准字H20265876See source | 2026/09/08 | Official source ↗ |
| Beijing Shi Qiao Biopharmaceutical Co., Ltd. romanized | 国药准字H20265595See source | 2026/08/04 | Official source ↗ |
| Jia Shi (Hunan) Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20264923See source | 2026/06/23 | Official source ↗ |
| Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized | 国药准字H20264379See source | 2026/05/19 | Official source ↗ |
| YaoPharma Co., Ltd. | 国药准字H20264118See source | 2026/04/21 | Official source ↗ |
| Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20263476See source | 2026/02/25 | Official source ↗ |
| Chengdu Xin Heng Chuang Pharma Co., Ltd. romanized | 国药准字H20249215See source | 2024/10/29 | Official source ↗ |
| Hainan Pu Li Pharmaceutical Co., Ltd. romanized | 国药准字H20223226See source | 2022/04/12 | Official source ↗ |
| Hunan Heng Sheng Pharmaceutical Co., Ltd. romanized | 国药准字H20256405See source | 2025/12/30 | Official source ↗ |
| Kang Pu Pharma Co., Ltd. romanized | 国药准字H20266289See source | 2026/10/20 | Official source ↗ |
NHSA approval numbers 10
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Beijing Shi Qiao Biopharmaceutical Co., Ltd. romanized | 国药准字H20265595See source | — | Official source ↗ |
| YaoPharma Co., Ltd. | 国药准字H20264118See source | — | Official source ↗ |
| Shandong Qidu Pharmaceutical Co., Ltd. | 国药准字H20265876See source | — | Official source ↗ |
| Hunan Heng Sheng Pharmaceutical Co., Ltd. romanized | 国药准字H20256405See source | — | Official source ↗ |
| Hainan Pu Li Pharmaceutical Co., Ltd. romanized | 国药准字H20223226See source | — | Official source ↗ |
| Chengdu Xin Heng Chuang Pharma Co., Ltd. romanized | 国药准字H20249215See source | — | Official source ↗ |
| Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized | 国药准字H20264379See source | — | Official source ↗ |
| Jia Shi (Hunan) Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20264923See source | — | Official source ↗ |
| Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20263476See source | — | Official source ↗ |
| Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized | 国药准字H20263476See source | — | Official source ↗ |
| Caplin Steriles Limited | 国药准字HJ20260085See source | — | Official source ↗ |
Under review 15
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Nanjing Hai Na Pharmaceutical Co., Ltd. romanized | CYHS2503804 | 2025/10/28 | Official source ↗ |
| Yang Zhou Zhong Bao Pharma Co., Ltd. romanized | CYHS2600947 | 2026/04/24 | Official source ↗ |
| Dan Dong Yi Chuang Pharma Co., Ltd. romanized | CYHS2602475 | 2026/10/10 | Official source ↗ |
| Shanghai He Feng Pharmaceutical Co., Ltd. romanized | CYHS2503741 | 2025/10/21 | Official source ↗ |
| Sichuan Qi Yu Pharmaceuticals Technology Co., Ltd. romanized; Kang Pu Pharma Co., Ltd. romanized | CYHS2503444 | 2025/09/18 | Official source ↗ |
| Hua Run Shuang He Pharma Co., Ltd. romanized | CYHS2503066 | 2025/08/20 | Official source ↗ |
| Sichuan Jian Lin Pharma Co., Ltd. romanized; Sichuan Ke Rui De Pharmaceutical Co., Ltd. romanized | CYHS2502341 | 2025/07/02 | Official source ↗ |
| Guangzhou Shi Ji Pharmaceuticals Technology Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd. | CYHS2502228 | 2025/06/20 | Official source ↗ |
| Hainan Brilliant Pharmaceutical Co., Ltd. | CYHS2502213 | 2025/06/20 | Official source ↗ |
| Ren He Yi Kang Hui Ze Pharma Hebei Co., Ltd. romanized | CYHS2502175 | 2025/06/18 | Official source ↗ |
| Hebei Yi Pin Pharmaceutical Co., Ltd. romanized | CYHS2502011 | 2025/06/06 | Official source ↗ |
| Shandong Qidu Pharmaceutical Co., Ltd. | CYHS2501982 | 2025/06/05 | Official source ↗ |
| Shandong Qidu Pharmaceutical Co., Ltd. | CYHS2501981 | 2025/06/05 | Official source ↗ |
| Hainan Hai He Pharmaceutical Co., Ltd. romanized; Hainan Ling Kang Pharmaceutical Co., Ltd. romanized | CYHS2501159 | 2025/03/25 | Official source ↗ |
| Hainan Ai Ke Pharmaceutical Co., Ltd. romanized; Hainan Ling Kang Pharmaceutical Co., Ltd. romanized | CYHS2500578 | 2025/02/06 | Official source ↗ |
Generic-filing companies this year 2
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Yang Zhou Zhong Bao Pharma Co., Ltd. romanized | CYHS2600947 | 2026/04/24 | Official source ↗ |
| Dan Dong Yi Chuang Pharma Co., Ltd. romanized | CYHS2602475 | 2026/10/10 | Official source ↗ |
API companies with A status 17
| Company (original) | Identifier (original) | Source date | Official source |
|---|---|---|---|
| Hebei An Jian Cheng Yi Pharmaceuticals Technology Co., Ltd. romanized | Y20250000236 | 2026/09/11 | Official source ↗ |
| Anhui Pu Li Pharma Co., Ltd. romanized | Y20240001218 | 2026/03/26 | Official source ↗ |
| Shandong Chuan Cheng Pharmaceuticals Co., Ltd. romanized | Y20240000799 | 2026/10/31 | Official source ↗ |
| Shuang He Pharma (Shang Qiu) Co., Ltd. romanized | Y20240000362 | 2025/08/22 | Official source ↗ |
| Hunan Heng Sheng Pharmaceutical Co., Ltd. romanized | Y20240000094 | 2025/08/26 | Official source ↗ |
| Azico Biophore India Pvt Ltd | Y20230001195 | 2026/08/28 | Official source ↗ |
| Henan Zhong Shuai Pharma Co., Ltd. romanized | Y20220001337 | 2024/09/29 | Official source ↗ |
| Chengdu Xin Heng Chuang Pharma Co., Ltd. romanized | Y20220001181 | 2025/12/20 | Official source ↗ |
| Hunan Hua Na Da Pharmaceutical Factory Shou Xing Drug Co., Ltd. romanized | Y20210000083 | 2026/04/14 | Official source ↗ |
| San Men Xia Sai Nuo Wei Pharmaceutical Co., Ltd. romanized | Y20190009710 | 2025/03/14 | Official source ↗ |
| Hubei Ge Dian Ren Fu Pharma Co., Ltd. romanized | Y20190007504 | 2025/03/01 | Official source ↗ |
| Hua Run Shuang He Pharma Co., Ltd. romanized | Y20190005092 | 2025/07/29 | Official source ↗ |
| Kang Pu Pharma Co., Ltd. romanized | Y20190004573 | 2026/03/21 | Official source ↗ |
| Shanghai Di Ran Dan Cheng Pharmaceutical Co., Ltd. romanized | Y20190004349 | 2024/11/01 | Official source ↗ |
| Beijing Shi Qiao Biopharmaceutical Co., Ltd. romanized | Y20190003626 | — | Official source ↗ |
| Dan Dong Yi Chuang Pharma Co., Ltd. romanized | Y20190002726 | 2025/05/22 | Official source ↗ |
| Hainan Pu Li Pharmaceutical Co., Ltd. romanized | Y20190000020 | 2024/03/14 | Official source ↗ |
| San Men Xia Sai Nuo Wei Pharmaceutical Co., Ltd. romanized | Y20170002000 | 2022/10/18 | 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 ↗ · 27-270 · 2020/06/04
- Chinese Pharmacopoeia 2025, formulation chapter; site crosswalk ↗ · See source
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