Data / Drug companies / Promethazine hydrochloride and dextromethorphan hydrobromide
Promethazine hydrochloride and dextromethorphan hydrobromide: 12 companies and 14 products in the FDA NDC directory
Updated November 6, 2026. Source: US Food and Drug Administration, National Drug Code Directory (openFDA).
Promethazine hydrochloride and dextromethorphan hydrobromide is listed in the FDA National Drug Code Directory by 12 companies, with 14 products in commercial distribution. 12 of the products (85.7%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are solution; syrup, and the newest product started marketing on June 23, 2026.
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- Companies listing it
- 12
- Products
- 14
- Generic (ANDA) products
- 12 (85.7%)
- Application numbers
- 7
- Routes
- Oral
- Brand names
- Promethazine DM
- openFDA record search
- api.fda.gov
Companies that list promethazine hydrochloride and dextromethorphan hydrobromide
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| A-S Medication Solutions | 3 | syrup; solution | Generic drugs (ANDA) | April 7, 2025 |
| Advagen Pharma Ltd | 1 | solution | Generic drugs (ANDA) | June 23, 2026 |
| Amneal Pharmaceuticals LLC | 1 | solution | Generic drugs (ANDA) | March 4, 2011 |
| Ani Pharmaceuticals, Inc. | 1 | solution | Authorized generics (NDA) | September 5, 2024 |
| Asclemed USA, Inc. | 1 | solution | Authorized generics (NDA) | September 5, 2024 |
| Atlantic Biologicals Corp. | 1 | syrup | Generic drugs (ANDA) | April 7, 2025 |
| Bryant Ranch Prepack | 1 | solution | Generic drugs (ANDA) | January 31, 2014 |
| Camber Pharmaceuticals, Inc. | 1 | solution | Generic drugs (ANDA) | March 12, 2026 |
| Cosette Pharmaceuticals, Inc. | 1 | solution | Generic drugs (ANDA) | September 19, 2025 |
| Cranbury Pharmaceuticals, LLC | 1 | solution | Generic drugs (ANDA) | January 31, 2014 |
| Pai Holdings, LLC DBA Pai Pharma | 1 | solution | Generic drugs (ANDA) | June 4, 2025 |
| Xttrium Laboratories, Inc. | 1 | syrup | Generic drugs (ANDA) | April 7, 2025 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Solution | 10 | 71.4% |
| Syrup | 4 | 28.6% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| Generic drugs (ANDA) | 12 | 85.7% |
| Authorized generics (NDA) | 2 | 14.3% |
Pharmacologic classes
| Class | Products |
|---|---|
| Phenothiazine | 14 |
| Sigma-1 Agonist | 14 |
| Uncompetitive N-methyl-D-aspartate Receptor Antagonist | 14 |
CC0 1.0 public domain dedication (openFDA). Counts are products in the FDA National Drug Code Directory on November 6, 2026: 138,262 products in commercial distribution, meaning without a marketing end date in the past. A company is a labeler code; one company can hold several codes, and the directory carries no address. Inclusion in the directory is not FDA approval, and the marketing category says under which kind of application or rule a product is sold. This page uses openFDA data and is not endorsed or certified by FDA. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.