Drug
Who makes promethazine hydrochloride and dextromethorphan hydrobromide?
12 companies list promethazine hydrochloride and dextromethorphan hydrobromide as a human prescription drug. Forms: solution; syrup. Routes: oral.
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 and dextromethorphan hydrobromide
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| International Medication Systems, Ltd.United States | solution; syrup | ANDAANDA088864, ANDA091687 | 3 | 3 |
| Xttrium Laboratories, Inc.United States | syrup | ANDAANDA088864 | 1 | 2 |
| ANI Pharmaceuticals, Inc.United States | solution | NDA AUTHORIZED GENERICNDA011265 | 1 | 1 |
| ASCLEMED USA INC. DBA ENOVACHEMUnited States | solution | NDA AUTHORIZED GENERICNDA011265 | 1 | 1 |
| Amneal Ireland LimitedIreland | solution | ANDAANDA090575 | 1 | 1 |
| Bryant Ranch PrepackUnited States | solution | ANDAANDA091687 | 1 | 1 |
| Camber Pharmaceuticals, Inc.United States | solution | ANDAANDA218264 | 1 | 1 |
| Cranbury Pharmaceuticals IncUnited States | solution | ANDAANDA091687 | 1 | 1 |
| PAI Holdings, LLCUnited States | solution | ANDAANDA040649 | 1 | 1 |
| South Atlantic Corporation LLCUnited States | syrup | ANDAANDA088864 | 1 | 1 |
| Advagen Pharma Limited | solution | ANDAANDA220869 | 1 | 0 |
| Cosette Pharmaceuticals, Inc. | solution | ANDAANDA091687 | 1 | 0 |
Enquiry
Common questions
- Who makes promethazine hydrochloride and dextromethorphan hydrobromide?
- 12 companies list promethazine hydrochloride and dextromethorphan hydrobromide as a human prescription drug in the openFDA NDC Directory, led by International Medication Systems, Ltd., Xttrium Laboratories, Inc., ANI Pharmaceuticals, Inc., ASCLEMED USA INC. DBA ENOVACHEM, Amneal Ireland Limited. 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 and dextromethorphan hydrobromide?
- 10 companies list promethazine hydrochloride and dextromethorphan hydrobromide 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.