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FDA Drug Shortages

Current and Resolved Drug Shortages and Discontinuations Reported to FDA

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Promethazine Hydrochloride Injection
Status: Currently in Shortage
»Date first posted: 11/21/2023
»Therapeutic Categories: Analgesia/Addiction; Gastroenterology; Pediatric; Pulmonary/Allergy

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Hikma Pharmaceuticals USA, Inc. (Revised 09/18/2026)

Company Contact Information:
800-631-2174

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Promethazine Hydrochloride, Injection, 25 mg/1 mL (NDC 0641-0928-25) Unavailable Additional lots will be available in the October 2026 timeframe. Product will be made available as it is released. Demand increase for the drug
Promethazine Hydrochloride, Injection, 50 mg/1 mL (NDC 0641-0929-25) Limited Availability Estimated recovery: TBD Demand increase for the drug
Promethazine Hydrochloride, Injection, 25 mg/1 mL (NDC 0641-1495-35) Available Limited availability Demand increase for the drug
Promethazine Hydrochloride, Injection, 50 mg/1 mL (NDC 0641-1496-35) Available Additional lots are scheduled to be manufactured. Product will be made available as it is released.
Phenergan, Injection, 25 mg/1 mL (NDC 0641-6084-25) Unavailable Estimated recovery: TBD Other
Phenergan, Injection, 50 mg/1 mL (NDC 0641-6085-25) Unavailable Estimated recovery: TBD Other
Phenergan, Injection, 25 mg/1 mL (NDC 0641-6082-25) Unavailable Additional lots are scheduled to be manufactured. Product will be made available as it is released. Other
Phenergan, Injection, 50 mg/1 mL (NDC 0641-6083-25) Unavailable Additional lots are scheduled to be manufactured. Product will be made available as it is released.

XGen Pharmaceuticals DJB, Inc. (Reverified 09/22/2026)

Company Contact Information:
866-390-4411

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Promethazine Hydrochloride, Injection, 25 mg/1 mL (NDC 39822-5525-3) Available
Promethazine Hydrochloride, Injection, 50 mg/1 mL (NDC 39822-5550-6) Unvailable Estimated recovery: TBD Demand increase for the drug
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