Promethazine Hydrochloride Injection
Hikma Pharmaceuticals USA, Inc. · Unavailable · Reason: Demand increase for the drug
Open FDA's page for this record- Update type
- Revised
- Initial posting date
- 11/21/2023
- Package NDC
- 0641-0928-25
- Generic name
- Promethazine Hydrochloride Injection
- Contact info
- 800-631-2174
- Availability
- Unavailable
- Related info
- Additional lots will be available in the October 2026 timeframe. Product will be made available as it is released.
- Update date
- 09/18/2026
- Dosage form
- Injection
- Presentation
- Promethazine Hydrochloride, Injection, 25 mg/1 mL (NDC 0641-0928-25)
- Company name
- Hikma Pharmaceuticals USA, Inc.
- Shortage reason
- Demand increase for the drug
- Status
- Current
- Therapeutic category
- Analgesia/Addiction, Gastroenterology, Pediatric, Pulmonary/Allergy
- Harmonized identifiers (openFDA)
- Application number
- ANDA083312
- Brand name
- PROMETHAZINE HYDROCHLORIDE
- Generic name
- PROMETHAZINE HYDROCHLORIDE
- Manufacturer name
- Hikma Pharmaceuticals USA Inc.
- Product NDC
- 0641-0928, 0641-0929
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- INTRAMUSCULAR, INTRAVENOUS
- Substance name
- PROMETHAZINE HYDROCHLORIDE
- RxCUI
- 992460, 992858
- SPL ID
- 9f14d3f5-ad01-44b5-a2b7-16ed5f501f87
- SPL set ID
- 4bf3912c-8339-401e-9711-dad6acf15f11
- Package NDC
- 0641-0928-21, 0641-0928-25, 0641-0929-21, 0641-0929-25
- UNII
- R61ZEH7I1I