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FDA shortage status: Promethazine Hydrochloride Injection
FDA source answer
FDA currently lists this ingredient in shortage.
FDA source statuses: Current. First FDA posting: 2023-11-21. Latest FDA row update: 2026-09-22.
FDA lists 10 package records, with companies: Hikma Pharmaceuticals USA Inc., Hikma Pharmaceuticals USA, Inc., XGen Pharmaceuticals DJB, Inc.. Package NDCs: 0641-0928-25, 0641-0929-25, 0641-1495-35, 0641-1496-35, 0641-6082-25, 0641-6083-25, 0641-6084-25, 0641-6085-25, 39822-5525-3, 39822-5550-6.
FDA shortage reason: 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 |
|---|---|---|---|---|
| Hikma Pharmaceuticals USA, Inc. | 0641-6082-25 | Phenergan, Injection, 25 mg/1 mL (NDC 0641-6082-25) | Unavailable | 2026-09-18 |
| Hikma Pharmaceuticals USA, Inc. | 0641-6084-25 | Phenergan, Injection, 25 mg/1 mL (NDC 0641-6084-25) | Unavailable | 2026-09-18 |
| Hikma Pharmaceuticals USA, Inc. | 0641-6083-25 | Phenergan, Injection, 50 mg/1 mL (NDC 0641-6083-25) | Unavailable | 2026-09-18 |
| Hikma Pharmaceuticals USA, Inc. | 0641-6085-25 | Phenergan, Injection, 50 mg/1 mL (NDC 0641-6085-25) | Unavailable | 2026-09-18 |
| Hikma Pharmaceuticals USA, Inc. | 0641-0928-25 | Promethazine Hydrochloride, Injection, 25 mg/1 mL (NDC 0641-0928-25) | Unavailable | 2026-09-18 |
| Hikma Pharmaceuticals USA, Inc. | 0641-1495-35 | Promethazine Hydrochloride, Injection, 25 mg/1 mL (NDC 0641-1495-35) | Available | 2026-09-18 |
| Hikma Pharmaceuticals USA, Inc. | 0641-0929-25 | Promethazine Hydrochloride, Injection, 50 mg/1 mL (NDC 0641-0929-25) | Limited Availability | 2026-09-18 |
| Hikma Pharmaceuticals USA, Inc. | 0641-1496-35 | Promethazine Hydrochloride, Injection, 50 mg/1 mL (NDC 0641-1496-35) | Available | 2026-09-18 |
| XGen Pharmaceuticals DJB, Inc. | 39822-5525-3 | Promethazine Hydrochloride, Injection, 25 mg/1 mL (NDC 39822-5525-3) | Available | 2026-09-22 |
| XGen Pharmaceuticals DJB, Inc. | 39822-5550-6 | Promethazine Hydrochloride, Injection, 50 mg/1 mL (NDC 39822-5550-6) | Unvailable | 2026-09-22 |
Source facts
Grouped generic ingredient: Promethazine Hydrochloride Injection · 10 package records
Therapeutic categories: Analgesia/Addiction, Gastroenterology, Other, Pediatric, Pulmonary/Allergy
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.