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FDA shortage status: Atropine Sulfate Injection
FDA source answer
FDA currently lists this ingredient in shortage.
FDA source statuses: Current, To Be Discontinued. First FDA posting: 2012-01-01. Latest FDA row update: 2026-10-03.
FDA lists 19 package records, with companies: Accord Healthcare Inc., Accord Healthcare, Inc.,, American Regent, Inc., Amphastar Pharmaceuticals, Inc., Fresenius Kabi USA, LLC, Hikma Pharmaceuticals USA Inc., Hikma Pharmaceuticals USA, Inc., Hospira, Inc., Hospira, Inc., a Pfizer Company, International Medication Systems, Limited, Medefil, Inc., Somerset Therapeutics, LLC. Package NDCs: 0409-1630-10, 0409-4910-34, 0409-4911-34, 0409-9630-05, 0517-1001-25, 0517-1004-25, 0641-6251-10, 16729-483-03, 16729-484-45, 16729-484-90, 16729-512-43, 16729-525-08, 16729-526-08, 63323-580-20, 64253-400-91, 70069-481-10, 70069-631-25, 70069-641-25, 76329-3340-1.
FDA shortage reason: Discontinuation of the manufacture of the drug; Other; Requirements related to complying with good manufacturing practices
This is nationwide FDA status, not local pharmacy inventory. CiteFacts does not provide medical, treatment, substitution, or dosing advice.
FDA package and manufacturer records
| Company | Package NDC | Presentation | FDA availability field | FDA update |
|---|---|---|---|---|
| Accord Healthcare Inc. | 16729-483-03 | Atropine Sulfate, Injection, .05 mg/1 mL (NDC 16729-483-03) | Unavailable | 2026-10-03 |
| Accord Healthcare Inc. | 16729-484-90 | Atropine Sulfate, Injection, .1 mg/1 mL (NDC 16729-484-90) | Unavailable | 2026-10-03 |
| Accord Healthcare Inc. | 16729-512-43 | Atropine Sulfate, Injection, .4 mg/1 mL (NDC 16729-512-43) | Unavailable | 2026-09-01 |
| Accord Healthcare Inc. | 16729-525-08 | Atropine Sulfate, Injection, .4 mg/1 mL (NDC 16729-525-08) | Unavailable | 2026-09-01 |
| Accord Healthcare Inc. | 16729-484-45 | Atropine Sulfate, Injection, 0.1 mg/1 mL (NDC 16729-484-45) | Available | 2026-10-03 |
| Accord Healthcare Inc. | 16729-526-08 | Atropine Sulfate, Injection, 1 mg/1 mL (NDC 16729-526-08) | Unavailable | 2026-09-01 |
| American Regent, Inc. | 0517-1004-25 | Atropine Sulfate, Injection, .4 mg/1 mL (NDC 0517-1004-25) | Available | 2026-10-01 |
| American Regent, Inc. | 0517-1001-25 | Atropine Sulfate, Injection, 1 mg/1 mL (NDC 0517-1001-25) | Available | 2026-10-01 |
| Amphastar Pharmaceuticals, Inc. | 76329-3340-1 | Atropine Sulfate, Injection, .1 mg/1 mL (NDC 76329-3340-1) | Available | 2026-09-16 |
| Fresenius Kabi USA, LLC | 63323-580-20 | Atropine Sulfate, Injection, .4 mg/1 mL (NDC 63323-580-20) | Available | 2026-09-01 |
| Hikma Pharmaceuticals USA, Inc. | 0641-6251-10 | Atropine Sulfate, Injection, 0.4 mg/1 mL (NDC 0641-6251-10) | Available | 2026-09-18 |
| Hospira, Inc., a Pfizer Company | 0409-4910-34 | Atropine Sulfate, Injection, (Adult) 0.5 mg/5 mL (0.1 mg/mL) LifeShield® ABBOJECT® Glass Syringe (20 G x 1 1/2) (NDC 0409-4910-34)" | Not stated | 2025-11-07 |
| Hospira, Inc., a Pfizer Company | 0409-4911-34 | Atropine Sulfate, Injection, (Adult)1 mg/10 mL (0.1 mg/mL) LifeShield® ABBOJECT® Glass Syringe (20 G x 1 1/2) (NDC 0409-4911-34)" | Not stated | 2025-11-07 |
| Hospira, Inc., a Pfizer Company | 0409-9630-05 | Atropine Sulfate, Injection, 0.25 mg/5 mL (0.05 mg/mL) Syringes (NDC 0409-9630-05) | Available | 2026-09-22 |
| Hospira, Inc., a Pfizer Company | 0409-1630-10 | Atropine Sulfate, Injection, 1 mg/10 mL (0.1 mg/mL) Syringes (NDC 0409-1630-10) | Unavailable | 2026-08-24 |
| Medefil, Inc. | 64253-400-91 | Atropine Sulfate, Injection, 1 mg/10 mL (0.1 mg/mL) Syringes (NDC 64253-400-91) | Available | 2026-09-15 |
| Somerset Therapeutics, LLC | 70069-481-10 | Atropine Sulfate, Injection, .4 mg/1 mL (NDC 70069-481-10) | Available | 2026-09-11 |
| Somerset Therapeutics, LLC | 70069-631-25 | Atropine Sulfate, Injection, .4 mg/1 mL (NDC 70069-631-25) | Available | 2026-09-11 |
| Somerset Therapeutics, LLC | 70069-641-25 | Atropine Sulfate, Injection, 1 mg/1 mL (NDC 70069-641-25) | Available | 2026-09-11 |
Source facts
Grouped generic ingredient: Atropine Sulfate Injection · 19 package records
Therapeutic categories: Anesthesia, Neurology, Pediatric
Dosage forms: Injection
Routes: ENDOTRACHEAL, INTRAMEDULLARY, INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Open FDA source data · JSON · Markdown
FDA is authoritative. Source retrieved 2026-10-06T18:55:41+00:00. Derived grouping is documented in this record's derivations.