Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide
- Product NDC
- 68999-302
- 11-digit product format
- 689990302
- Labeler code
- 68999
- Product ID
- 68999-302_4472f94a-77ad-02c3-e063-6294a90a9cf6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- Chartwell Governmental & Specialty RX, LLC
- Application
- ANDA213125
- Marketing category
- ANDA
- Marketing start
- 2020-04-17
- 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 |
|---|
| 68999-302-05 | Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide | 5 mL in 1 CUP | SYRUP | 5 | | 1 |
| 68999-302-24 | Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide | 10 in 1 TRAY | SYRUP | 10 | | 1 |
| 68999-302-24 | Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide | 2 in 1 BOX | SYRUP | 2 | | 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 |
|---|
| 68999-302-05 | 68999030205 | 5 mL in 1 CUP | 5 ml | | | | Historical |
| 68999-302-24 | 68999030224 | 2 TRAY in 1 BOX (68999-302-24) / 10 CUP in 1 TRAY / 5 mL in 1 CUP (68999-302-05) | 2 tray | 2025-10-30 | No | No | Historical |