Drug
Who makes promethazine hydrochloride?
42 companies list promethazine hydrochloride as a human prescription drug, including under the names PHENERGAN, PROMETHEGAN. Forms: injection; injection, solution; solution; suppository; syrup; tablet. Routes: intramuscular, intravenous, oral, rectal.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing promethazine hydrochloride
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Hikma Pharmaceuticals USA Inc.United States | injection | ANDAANDA083312 | 13 | 4 |
| International Medication Systems, Ltd.United States | injection; suppository; syrup; tablet | ANDAANDA040500, ANDA040596, ANDA040712 | 12 | 3 |
| ASCLEMED USA INC. DBA ENOVACHEMUnited States | suppository; tablet | ANDAANDA040500, ANDA040596 | 8 | 1 |
| PD-Rx Pharmaceuticals Inc.United States | suppository; tablet | ANDAANDA040428, ANDA040500, ANDA040712 | 7 | 1 |
| Bryant Ranch PrepackUnited States | solution; tablet | ANDAANDA040596, ANDA040712, ANDA040891 | 6 | 1 |
| NuCare Pharmaceuticals,Inc.United States | tablet | ANDAANDA040596, ANDA040712, ANDA083426 | 6 | 1 |
| Northwind Health Company, LLCUnited States | tablet | ANDAANDA040596, ANDA040712, ANDA083426 | 5 | 1 |
| Proficient Rx LPUnited States | tablet | ANDAANDA040596, ANDA040712, ANDA083426 | 4 | 1 |
| Amneal Pharmaceuticals of New York, LLCIndia | tablet | ANDAANDA091179 | 3 | 14 |
| Zydus Lifesciences LimitedIndia | tablet | ANDAANDA040596 | 3 | 12 |
| KVK-TECH, INC.United States | tablet | ANDAANDA040712 | 3 | 2 |
| Amneal Ireland LimitedIreland | tablet | ANDAANDA091179 | 3 | 1 |
| Henry Schein, Inc.United States | injection | ANDAANDA083312 | 3 | 1 |
| RemedyRepack, IncUnited States | tablet | ANDAANDA040596 | 3 | 1 |
| Zydus Pharmaceuticals USA Inc.India | tablet | ANDAANDA040596 | 3 | 1 |
| BluePoint Laboratories Inc. | tablet | ANDAANDA040596 | 3 | 0 |
| Cosette Pharmaceuticals, Inc. | suppository | ANDAANDA040428, ANDA087165 | 3 | 0 |
| Sportpharm LLC | tablet | ANDAANDA040596 | 3 | 0 |
| Cardinal Health 418, Inc.United States | injection; tablet | ANDAANDA083312, ANDA091179 | 2 | 34 |
| Pharma Packaging Solutions, LLC dba Tjoapack, LLCUnited States | tablet | ANDAANDA040596 | 2 | 5 |
| ProPharma Distribution, LLC.United States | injection; injection, solution | ANDAANDA040737, ANDA083312 | 2 | 3 |
| Padagis Israel Pharmaceuticals LtdUnited States | suppository | ANDAANDA040500 | 2 | 2 |
| Camber Pharmaceuticals, Inc.United States | suppository | ANDAANDA216446 | 2 | 1 |
| Coupler LLCUnited States | tablet | ANDAANDA040596 | 2 | 1 |
| Medical Purchasing Solutions, LLCUnited States | injection | ANDAANDA083312 | 2 | 1 |
| South Atlantic Corporation LLCUnited States | syrup | ANDAANDA087953, ANDA091675 | 2 | 1 |
| XGen Pharmaceuticals DJB, Inc. | injection, solution | ANDAANDA040737 | 2 | 0 |
| QUAGEN PHARMACEUTICALS LLCUnited States | solution | ANDAANDA213890 | 1 | 2 |
| Xttrium Laboratories, Inc.United States | syrup | ANDAANDA087953 | 1 | 2 |
| ADVANCED RX PHARMACY OF TENNESSEE LLCUnited States | tablet | ANDAANDA040596 | 1 | 1 |
| Actavis LLCUnited States | tablet | ANDAANDA083711 | 1 | 1 |
| Cranbury Pharmaceuticals IncUnited States | syrup | ANDAANDA091675 | 1 | 1 |
| Direct RxUnited States | tablet | ANDAANDA040596 | 1 | 1 |
| Kesin Pharma CorporationUnited States | solution | ANDAANDA040891 | 1 | 1 |
| NCS HealthCare of KY, LLC dba Vangard LabsUnited States | tablet | ANDAANDA040596 | 1 | 1 |
| PAI Holdings, LLCUnited States | solution | ANDAANDA040643 | 1 | 1 |
| Preferred Pharmaceuticals Inc.United States | tablet | ANDAANDA040596 | 1 | 1 |
| RedPharm DrugUnited States | tablet | ANDAANDA040596 | 1 | 1 |
| Unit Dose Solutions, Inc.United States | tablet | ANDAANDA040596 | 1 | 1 |
| Chartwell Governmental & Specialty RX, LLC. | solution | ANDAANDA040026 | 1 | 0 |
| Chartwell RX, LLC. | solution | ANDAANDA040026 | 1 | 0 |
| MAJOR Pharmaceuticals Inc. | tablet | ANDAANDA091179 | 1 | 0 |
Bulk ingredient listings
- Professional Compounding Centers of America dba PCCAUnited States · 2 NDC
- EGIS Pharmaceuticals PLCHungary · 1 NDC
- EUROAPIFrance · 1 NDC
- Emcure Pharmaceuticals LimitedIndia · 1 NDC
- Fagron Services B.V.Netherlands · 1 NDC
- KALINTIS HEALTHCARE PRIVATE LIMITEDIndia · 1 NDC
- MEDISCA Inc.United States · 1 NDC
- Sanofi Winthrop Industrie · 1 NDC
- Sigma-Aldrich CorporationUnited States · 1 NDC
- Zydus Lifesciences LimitedIndia · 1 NDC
Enquiry
Common questions
- Who makes promethazine hydrochloride?
- 42 companies list promethazine hydrochloride as a human prescription drug in the openFDA NDC Directory, led by Hikma Pharmaceuticals USA Inc., International Medication Systems, Ltd., ASCLEMED USA INC. DBA ENOVACHEM, PD-Rx Pharmaceuticals Inc., Bryant Ranch Prepack. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic promethazine hydrochloride?
- 42 companies list promethazine hydrochloride under an abbreviated new drug application (ANDA), the application type used for generics. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies promethazine hydrochloride active ingredient?
- 10 companies list promethazine hydrochloride as a bulk ingredient, including Professional Compounding Centers of America dba PCCA, EGIS Pharmaceuticals PLC, EUROAPI, Emcure Pharmaceuticals Limited.