Promethazine Hydrochloride and Dextromethorphan Hydrobromide
- Product NDC
- 50090-6755
- 11-digit product format
- 500906755
- Labeler code
- 50090
- Product ID
- 50090-6755_488420f1-eee8-408d-86eb-45209304a36c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Promethazine Hydrochloride and Dextromethorphan Hydrobromide
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA091687
- Marketing category
- ANDA
- Marketing start
- 2014-01-31
- 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 |
|---|
| 50090-6755-0 | 50090675500 | 473 mL in 1 BOTTLE, PLASTIC (50090-6755-0) | 473 ml | 2023-10-17 | No | No | Historical |
| 50090-6755-1 | 50090675501 | 4 BOTTLE in 1 BOTTLE (50090-6755-1) / 118 mL in 1 BOTTLE | 4 bottle | 2024-02-05 | No | No | Historical |