Promethazine Hydrochloride and Dextromethorphan Hydrobromide
- Product NDC
- 0713-0780
- 11-digit product format
- 007130780
- Labeler code
- 0713
- Product ID
- 0713-0780_3f7c7c58-c76e-b49c-e063-6294a90ace09
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Promethazine Hydrochloride and Dextromethorphan Hydrobromide
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Cosette Pharmaceuticals, Inc.
- Application
- ANDA091687
- Marketing category
- ANDA
- Marketing start
- 2025-09-19
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Promethazine Hydrochloride and Dextromethorphan Hydrobromide
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 15 mg/5mL |
| PROMETHAZINE HYDROCHLORIDE | 6.25 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9D2RTI9KYH, R61ZEH7I1I |
| Rxcui | 991528 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0713-0780-75 | Promethazine Hydrochloride and Dextromethorphan Hydrobromide | 473 mL in 1 BOTTLE, PLASTIC | SOLUTION | 473 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0713-0780-75 | 00713078075 | 473 mL in 1 BOTTLE, PLASTIC (0713-0780-75) | 473 ml | 2025-09-19 | No | No | Current |