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FDA shortage status: Ketorolac Tromethamine Injection
FDA source answer
FDA currently lists this ingredient in shortage.
FDA source statuses: Current. First FDA posting: 2018-03-23. Latest FDA row update: 2026-10-02.
FDA lists 25 package records, with companies: Alembic Pharmaceuticals, Alembic Pharmaceuticals Inc., Baxter Healthcare, Baxter Healthcare Corporation, FOSUN PHARMA USA INC, Fresenius Kabi USA, LLC, Gland Pharma Limited, Hikma Pharmaceuticals USA Inc., Hikma Pharmaceuticals USA, Inc., Hospira, Inc., Hospira, Inc., a Pfizer Company, Sagent Pharmaceuticals. Package NDCs: 0338-0069-10, 0338-0072-25, 0409-3793-01, 0409-3795-01, 0409-3796-01, 0641-6041-25, 0641-6042-25, 0641-6043-25, 25021-700-01, 25021-701-01, 25021-701-02, 62332-599-25, 62332-600-25, 62332-601-25, 63323-161-01, 63323-162-01, 63323-162-02, 72266-118-25, 72266-119-25, 76045-104-10, 76045-105-20, 76045-107-10.
FDA shortage reason: Delay in shipping of the drug; Demand increase for 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 |
|---|---|---|---|---|
| Alembic Pharmaceuticals | 62332-599-25 | Ketorolac Tromethamine, Injection, 15 mg/1 mL (NDC 62332-599-25) | Available | 2026-05-15 |
| Alembic Pharmaceuticals | 62332-600-25 | Ketorolac Tromethamine, Injection, 30 mg/1 mL (NDC 62332-600-25) | Available | 2026-05-15 |
| Alembic Pharmaceuticals | 62332-601-25 | Ketorolac Tromethamine, Injection, 60 mg/2 mL (NDC 62332-601-25) | Available | 2026-05-15 |
| Baxter Healthcare | 0338-0069-10 | Ketorolac Tromethamine, Injection, 15 mg/1 mL (NDC 0338-0069-10) | Unavailable | 2026-10-02 |
| Baxter Healthcare | 0338-0072-25 | Ketorolac Tromethamine, Injection, 30 mg/1 mL (NDC 0338-0072-25) | Available | 2026-10-02 |
| Fresenius Kabi USA, LLC | 63323-161-01 | Ketorolac Tromethamine, Injection, 15 mg/1 mL (NDC 63323-161-01) | Available | 2026-09-15 |
| Fresenius Kabi USA, LLC | 76045-107-10 | Ketorolac Tromethamine, Injection, 15 mg/1 mL (NDC 76045-107-10) | Unavailable | 2026-09-15 |
| Fresenius Kabi USA, LLC | 63323-162-01 | Ketorolac Tromethamine, Injection, 30 mg/1 mL (NDC 63323-162-01) | Unavailable | 2026-09-15 |
| Fresenius Kabi USA, LLC | 63323-162-02 | Ketorolac Tromethamine, Injection, 30 mg/1 mL (NDC 63323-162-02) | Unavailable | 2026-09-15 |
| Fresenius Kabi USA, LLC | 76045-104-10 | Ketorolac Tromethamine, Injection, 30 mg/1 mL (NDC 76045-104-10) | Unavailable | 2026-09-15 |
| Fresenius Kabi USA, LLC | 76045-105-20 | Ketorolac Tromethamine, Injection, 60 mg/2 mL (NDC 76045-105-20) | Unavailable | 2026-09-15 |
| Gland Pharma Limited | 25021-700-01 | Ketorolac Tromethamine, Injection, 15 mg/1 mL (NDC 25021-700-01) | Available | 2026-07-22 |
| Gland Pharma Limited | 25021-701-01 | Ketorolac Tromethamine, Injection, 30 mg/1 mL (NDC 25021-701-01) | Available | 2026-07-22 |
| Gland Pharma Limited | 25021-701-02 | Ketorolac Tromethamine, Injection, 30 mg/1 mL (NDC 25021-701-02) | Available | 2026-07-22 |
| Gland Pharma Limited | 72266-118-25 | Ketorolac Tromethamine, Injection, 30 mg/1 mL (NDC 72266-118-25) | Available | 2026-07-22 |
| Gland Pharma Limited | 72266-119-25 | Ketorolac Tromethamine, Injection, 30 mg/1 mL (NDC 72266-119-25) | Available | 2026-07-22 |
| Hikma Pharmaceuticals USA, Inc. | 0641-6041-25 | Ketorolac Tromethamine, Injection, 15 mg/1 mL (NDC 0641-6041-25) | Unavailable | 2026-09-18 |
| Hikma Pharmaceuticals USA, Inc. | 0641-6042-25 | Ketorolac Tromethamine, Injection, 30 mg/1 mL (NDC 0641-6042-25) | Unavailable | 2026-09-18 |
| Hikma Pharmaceuticals USA, Inc. | 0641-6043-25 | Ketorolac Tromethamine, Injection, 30 mg/1 mL (NDC 0641-6043-25) | Unavailable | 2026-09-18 |
| Hospira, Inc., a Pfizer Company | 0409-3793-01 | Ketorolac Tromethamine, Injection, 15 mg/1 mL (NDC 0409-3793-01) | Unavailable | 2026-09-22 |
| Hospira, Inc., a Pfizer Company | 0409-3795-01 | Ketorolac Tromethamine, Injection, 30 mg/1 mL (NDC 0409-3795-01) | Unavailable | 2026-09-22 |
| Hospira, Inc., a Pfizer Company | 0409-3796-01 | Ketorolac Tromethamine, Injection, 60 mg/2 mL (30 mg/mL) (NDC 0409-3796-01) | Unavailable | 2026-09-22 |
| Sagent Pharmaceuticals | 25021-700-01 | Ketorolac Tromethamine, Injection, 15 mg/1 mL (NDC 25021-700-01) | Unavailable | 2026-09-18 |
| Sagent Pharmaceuticals | 25021-701-01 | Ketorolac Tromethamine, Injection, 30 mg/1 mL (NDC 25021-701-01) | Available | 2026-09-18 |
| Sagent Pharmaceuticals | 25021-701-02 | Ketorolac Tromethamine, Injection, 30 mg/1 mL (NDC 25021-701-02) | Available | 2026-09-18 |
Source facts
Grouped generic ingredient: Ketorolac Tromethamine Injection · 25 package records
Therapeutic categories: Analgesia/Addiction
Dosage forms: Injection
Routes: INTRAMUSCULAR, 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.