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FDA shortage status: Morphine Sulfate Injection
FDA source answer
FDA currently lists this ingredient in shortage.
FDA source statuses: Current. First FDA posting: 2017-10-31. Latest FDA row update: 2026-09-22.
FDA lists 24 package records, with companies: Amphastar Pharmaceuticals, Inc., Fresenius Kabi USA, LLC, Fresenius Kabi, USA LLC, Hikma Pharmaceuticals USA Inc., Hikma Pharmaceuticals USA, Inc., Hospira, Inc., Hospira, Inc., a Pfizer Company, International Medication Systems, Limited, Piramal Critical Care Inc., Piramal Critical Care, Inc.. Package NDCs: 0409-1890-01, 0409-1890-23, 0409-1891-01, 0409-1893-01, 0409-1896-20, 0409-2022-01, 0409-3814-12, 0409-3815-12, 0641-6019-10, 0641-6020-10, 0641-6039-01, 0641-6040-01, 0641-6125-25, 0641-6126-25, 0641-6127-25, 63323-451-01, 63323-452-01, 63323-454-01, 63323-455-01, 66794-160-02, 66794-162-02, 76045-004-11, 76045-005-11, 76329-1912-1.
FDA shortage reason: Demand increase for the drug; Discontinuation of the manufacture of the drug; Other
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 |
|---|---|---|---|---|
| Amphastar Pharmaceuticals, Inc. | 76329-1912-1 | Morphine Sulfate, Injection, 1 mg/1 mL (NDC 76329-1912-1) | Available | 2026-09-16 |
| Fresenius Kabi USA, LLC | 63323-451-01 | Morphine Sulfate, Injection, 10 mg/1 mL (NDC 63323-451-01) | Available | 2026-09-15 |
| Fresenius Kabi USA, LLC | 63323-452-01 | Morphine Sulfate, Injection, 2 mg/1 mL (NDC 63323-452-01) | Unavailable | 2026-09-15 |
| Fresenius Kabi USA, LLC | 76045-004-11 | Morphine Sulfate, Injection, 2 mg/1 mL (NDC 76045-004-11) | Unavailable | 2026-09-15 |
| Fresenius Kabi USA, LLC | 63323-454-01 | Morphine Sulfate, Injection, 4 mg/1 mL (NDC 63323-454-01) | Unavailable | 2026-09-15 |
| Fresenius Kabi USA, LLC | 76045-005-11 | Morphine Sulfate, Injection, 4 mg/1 mL (NDC 76045-005-11) | Unavailable | 2026-09-15 |
| Fresenius Kabi USA, LLC | 63323-455-01 | Morphine Sulfate, Injection, 5 mg/1 mL (NDC 63323-455-01) | Unavailable | 2026-09-15 |
| Hikma Pharmaceuticals USA, Inc. | 0641-6020-10 | Duramorph, Injection, .5 mg/1 mL (NDC 0641-6020-10) | Available | 2026-09-18 |
| Hikma Pharmaceuticals USA, Inc. | 0641-6019-10 | Duramorph, Injection, 1 mg/1 mL (NDC 0641-6019-10) | Available | 2026-09-18 |
| Hikma Pharmaceuticals USA, Inc. | 0641-6039-01 | Infumorph 200 (Preservative-Free Morphine Sulfate Sterile Solution), Injection, 10 mg/1 mL (NDC 0641-6039-01) | Unavailable | 2026-09-18 |
| Hikma Pharmaceuticals USA, Inc. | 0641-6040-01 | Infumorph 500 (Preservative-Free Morphine Sulfate Sterile Solution), Injection, 25 mg/1 mL (NDC 0641-6040-01) | Available | 2026-09-18 |
| Hikma Pharmaceuticals USA, Inc. | 0641-6127-25 | Morphine Sulfate, Injection, 10 mg/1 mL (NDC 0641-6127-25) | Unavailable | 2026-09-18 |
| Hikma Pharmaceuticals USA, Inc. | 0641-6125-25 | Morphine Sulfate, Injection, 4 mg/1 mL (NDC 0641-6125-25) | Available | 2026-09-18 |
| Hikma Pharmaceuticals USA, Inc. | 0641-6126-25 | Morphine Sulfate, Injection, 8 mg/1 mL (NDC 0641-6126-25) | unavailable | 2026-09-18 |
| Hospira, Inc., a Pfizer Company | 0409-1893-01 | Morphine Sulfate, Injection, 10 mg/1 mL Syringes (NDC 0409-1893-01) | Unavailable | 2026-09-22 |
| Hospira, Inc., a Pfizer Company | 0409-3815-12 | Morphine Sulfate, Injection, 10 mg/10 mL (1 mg/mL) (NDC 0409-3815-12) | Available | 2026-09-22 |
| Hospira, Inc., a Pfizer Company | 0409-1890-23 | Morphine Sulfate, Injection, 2 mg/1 mL (NDC 0409-1890-23) | Limited Availability | 2026-09-22 |
| Hospira, Inc., a Pfizer Company | 0409-1890-01 | Morphine Sulfate, Injection, 2 mg/1 mL Syringes (NDC 0409-1890-01) | Available | 2026-09-22 |
| Hospira, Inc., a Pfizer Company | 0409-1891-01 | Morphine Sulfate, Injection, 4 mg/1 mL Syringes (NDC 0409-1891-01) | Available | 2026-09-22 |
| Hospira, Inc., a Pfizer Company | 0409-3814-12 | Morphine Sulfate, Injection, 5 mg/10 mL (0.5 mg/mL) (NDC 0409-3814-12) | Available | 2026-09-22 |
| Hospira, Inc., a Pfizer Company | 0409-1896-20 | Morphine Sulfate, Injection, 50 mg/1 mL (NDC 0409-1896-20) | Unavailable | 2026-09-22 |
| Hospira, Inc., a Pfizer Company | 0409-2022-01 | Morphine Sulfate, Injection, 50 mg/1 mL (NDC 0409-2022-01) | Unavailable | 2026-09-22 |
| Piramal Critical Care Inc. | 66794-160-02 | Mitigo, Injection, 200 mg/20 mL (NDC 66794-160-02) | Available | 2026-09-15 |
| Piramal Critical Care Inc. | 66794-162-02 | Mitigo, Injection, 500 mg/20 mL (NDC 66794-162-02) | Available | 2026-09-15 |
Source facts
Grouped generic ingredient: Morphine Sulfate Injection · 24 package records
Therapeutic categories: Analgesia/Addiction
Dosage forms: Injection
Routes: EPIDURAL, INTRAMUSCULAR, INTRATHECAL, INTRAVENOUS
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.