Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide
- Product NDC
- 63629-8616
- 11-digit product format
- 636298616
- Labeler code
- 63629
- Product ID
- 63629-8616_98f7bb09-24b9-459e-9000-ce6387464e9c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA205292
- Marketing category
- ANDA
- Marketing start
- 2015-02-06
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide
- Listing expiration
- 2026-12-31
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 |
|---|
| 63629-8616-1 | Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide | 473 mL in 1 BOTTLE, PLASTIC | SYRUP | 473 | | 104 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63629-8616 | BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [BRYANT RANCH PREPACK] | 104 | Current NDC, Legacy NDC, 1 package rows | 20241006_4368822d-2779-4fb2-9ca9-f020b8934dc5.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63629-8616-1 | 63629861601 | 473 mL in 1 BOTTLE, PLASTIC (63629-8616-1) | 473 ml | 2015-02-06 | 0000-00-00 | No | No | Current |