Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution
- Product NDC
- 68071-3551
- 11-digit product format
- 680713551
- Labeler code
- 68071
- Product ID
- 68071-3551_2d3fb2d4-6352-3f26-e063-6294a90a0163
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA040649
- Marketing category
- ANDA
- Marketing start
- 2020-10-05
- 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 |
|---|
| 68071-3551-4 | 68071355104 | 118 mL in 1 BOTTLE (68071-3551-4) | 118 ml | 2023-12-01 | No | No | Historical |