Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide
- Product NDC
- 70518-4526
- 11-digit product format
- 705184526
- Labeler code
- 70518
- Product ID
- 70518-4526_4844c0ef-a0c8-f296-e063-6394a90a8c73
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA205292
- Marketing category
- ANDA
- Marketing start
- 2025-12-01
- Substance
- BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
- Active strength
- 2; 10; 30 mg/5mL; mg/5mL; mg/5mL
- Pharmacologic classes
- Adrenergic alpha-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BROMPHENIRAMINE MALEATE | 2 mg/5mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/5mL |
| PSEUDOEPHEDRINE HYDROCHLORIDE | 30 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | IXA7C9ZN03, 9D2RTI9KYH, 6V9V2RYJ8N |
| Rxcui | 1357010 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-4526-0 | Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide | 3 in 1 BOX | SYRUP | 3 | | 4 |
| 70518-4526-1 | Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide | 20 mL in 1 CUP | SYRUP | 20 | | 4 |
| 70518-4526-2 | Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide | 6 in 1 BOX | SYRUP | 6 | | 4 |
| 70518-4526-3 | Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide | 10 mL in 1 CUP | SYRUP | 10 | | 4 |
| 70518-4526-4 | Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide | 12 in 1 BOX | SYRUP | 12 | | 4 |
| 70518-4526-5 | Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide | 5 mL in 1 CUP | SYRUP | 5 | | 4 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-4526-0 | 70518452600 | 3 CUP in 1 BOX (70518-4526-0) / 20 mL in 1 CUP (70518-4526-1) | 3 cup | 2025-12-01 | No | No | Historical |
| 70518-4526-1 | 70518452601 | 20 mL in 1 CUP | 20 ml | | | | Historical |
| 70518-4526-2 | 70518452602 | 6 CUP in 1 BOX (70518-4526-2) / 10 mL in 1 CUP (70518-4526-3) | 6 cup | 2025-12-10 | No | No | Historical |
| 70518-4526-3 | 70518452603 | 10 mL in 1 CUP | 10 ml | | | | Historical |
| 70518-4526-4 | 70518452604 | 12 CUP in 1 BOX (70518-4526-4) / 5 mL in 1 CUP (70518-4526-5) | 12 cup | 2026-01-12 | No | No | Historical |
| 70518-4526-5 | 70518452605 | 5 mL in 1 CUP | 5 ml | | | | Historical |