Data / Drug companies / Atropine sulfate
Atropine sulfate: 24 companies and 69 products in the FDA NDC directory
Updated November 6, 2026. Source: US Food and Drug Administration, National Drug Code Directory (openFDA).
Atropine sulfate is listed in the FDA National Drug Code Directory by 24 companies, with 69 products in commercial distribution. 50 of the products (72.5%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are injection, solution; solution/ drops; injection, and the newest product started marketing on July 31, 2026.
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- Companies listing it
- 24
- Products
- 69
- Generic (ANDA) products
- 50 (72.5%)
- Application numbers
- 19
- Routes
- Intravenous, Ophthalmic, Intramuscular, Subcutaneous, Endotracheal
- Brand names
- Atropine, Atropine, Isopto Atropine
- openFDA record search
- api.fda.gov
Companies that list atropine sulfate
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| HF Acquisition Co LLC, DBA HealthFirst | 8 | injection, solution; injection | Generic drugs (ANDA) | July 14, 2023 |
| Medical Purchasing Solutions, LLC | 8 | injection; solution | Generic drugs (ANDA) | July 4, 2024 |
| Somerset Therapeutics, LLC | 5 | solution/ drops; solution | Generic drugs (ANDA) | February 12, 2025 |
| Accord Healthcare Inc. | 4 | injection, solution; injection | Generic drugs (ANDA) | July 30, 2021 |
| Henry Schein, Inc. | 4 | injection, solution | New drug applications (NDA) | June 16, 2025 |
| ProPharma Distribution | 4 | injection, solution; injection | Generic drugs (ANDA) | July 4, 2024 |
| A-S Medication Solutions | 3 | solution/ drops; injection | Generic drugs (ANDA) | July 19, 2022 |
| Amneal Pharmaceuticals NY LLC | 3 | solution/ drops | Generic drugs (ANDA) | July 19, 2022 |
| Gland Pharma Limited | 3 | solution/ drops | Generic drugs (ANDA) | July 31, 2026 |
| Hikma Pharmaceuticals USA Inc. | 3 | injection | Generic drugs (ANDA) | November 7, 2025 |
| Lifestar Pharma LLC | 3 | solution/ drops | Generic drugs (ANDA) | January 8, 2024 |
| Remedyrepack Inc. | 3 | injection; injection, solution | Generic drugs (ANDA) | April 15, 2025 |
| Alcon Laboratories, Inc. | 2 | solution | New drug applications (NDA) | November 1, 2022 |
| American Regent, Inc. | 2 | injection, solution | Generic drugs (ANDA) | August 2, 2022 |
| Amneal Pharmaceuticals LLC | 2 | injection, solution | Generic drugs (ANDA) | January 9, 2024 |
| Bausch & Lomb Incorporated | 2 | ointment; solution | Other unapproved drugs | July 13, 2022 |
| Hospira, Inc. | 2 | injection, solution | New drug applications (NDA) | January 19, 2006 |
| Redpharm Drug | 2 | solution/ drops | Generic drugs (ANDA) | January 8, 2024 |
| Apotex Corp. | 1 | solution/ drops | Generic drugs (ANDA) | November 26, 2021 |
| Bausch & Lomb Americas Inc. | 1 | solution | Authorized generics (NDA) | April 21, 2023 |
| Edenbridge Pharmaceuticals LLC. | 1 | solution/ drops | Generic drugs (ANDA) | May 6, 2026 |
| Fresenius Kabi USA, LLC | 1 | injection, solution | New drug applications (NDA) | January 23, 2017 |
| International Medication Systems, Limited | 1 | injection | Generic drugs (ANDA) | February 17, 2021 |
| NorthStar RxLLC | 1 | solution/ drops | Generic drugs (ANDA) | September 1, 2024 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Injection, solution | 23 | 33.3% |
| Solution/ drops | 19 | 27.5% |
| Injection | 17 | 24.6% |
| Solution | 9 | 13% |
| Ointment | 1 | 1.4% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 50 | 72.5% |
| New drug applications (NDA) | 13 | 18.8% |
| Other unapproved drugs | 5 | 7.2% |
| Authorized generics (NDA) | 1 | 1.4% |
Pharmacologic classes
| Class | Products |
|---|---|
| Anticholinergic | 69 |
| Cholinergic Muscarinic Antagonist | 69 |
CC0 1.0 public domain dedication (openFDA). Counts are products in the FDA National Drug Code Directory on November 6, 2026: 138,262 products in commercial distribution, meaning without a marketing end date in the past. A company is a labeler code; one company can hold several codes, and the directory carries no address. Inclusion in the directory is not FDA approval, and the marketing category says under which kind of application or rule a product is sold. This page uses openFDA data and is not endorsed or certified by FDA. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.