Promethazine Hydrochloride and Dextromethorphan Hydrobromide
- Product NDC
- 50090-6467
- 11-digit product format
- 500906467
- Labeler code
- 50090
- Product ID
- 50090-6467_17cc096b-1c05-43c4-a4e7-68f633ca212a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- promethazine hydrochloride and dextromethorphan hydrobromide
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA088864
- Marketing category
- ANDA
- Marketing start
- 1985-01-04
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE
- Active strength
- 15; 6.25 mg/5mL; mg/5mL
- Pharmacologic classes
- Phenothiazine [EPC], Phenothiazines [CS], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 9D2RTI9KYH | DEXTROMETHORPHAN HYDROBROMIDE | 6700-34-1 | DEXTROMETHORPHAN HYDROBROMIDE |
| R61ZEH7I1I | PROMETHAZINE HYDROCHLORIDE | 58-33-3 | PROMETHAZINE HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 50090-6467-0 | 50090646700 | 473 mL in 1 BOTTLE, PLASTIC (50090-6467-0) | 473 ml | 2023-05-08 | No | No | Historical |
| 50090-6467-1 | 50090646701 | 473 mL in 1 BOTTLE, PLASTIC (50090-6467-1) | 473 ml | 2023-05-08 | No | No | Historical |