Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide
- Product NDC
- 42192-607
- 11-digit product format
- 421920607
- Labeler code
- 42192
- Product ID
- 42192-607_4d260aef-5897-199f-e063-6394a90a522a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- Acella Pharmaceuticals, LLC
- Application
- ANDA203375
- Marketing category
- ANDA
- Marketing start
- 2016-09-21
- 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, 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 |
|---|
| 42192-607-04 | Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide | 118 mL in 1 BOTTLE, PLASTIC | SYRUP | 118 | | 10 |
| 42192-607-05 | Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide | 5 mL in 1 CUP, UNIT-DOSE | SYRUP | 5 | | 10 |
| 42192-607-16 | Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide | 473 mL in 1 BOTTLE, PLASTIC | SYRUP | 473 | | 10 |
| 42192-607-40 | Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide | 40 in 1 CASE | SYRUP | 40 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42192-607 | BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [ACELLA PHARMACEUTICALS, LLC] | 8 | Current NDC, Legacy NDC, 4 package rows | 20241004_1045e307-f60d-482d-8e06-40e72b84c651.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 |
|---|
| 42192-607-04 | 42192060704 | 118 mL in 1 BOTTLE, PLASTIC (42192-607-04) | 118 ml | 2016-09-21 | 0000-00-00 | No | No | Current |
| 42192-607-05 | 42192060705 | 5 mL in 1 CUP, UNIT-DOSE | 5 ml | | | | | Historical |
| 42192-607-16 | 42192060716 | 473 mL in 1 BOTTLE, PLASTIC (42192-607-16) | 473 ml | 2016-09-21 | 0000-00-00 | No | No | Current |
| 42192-607-40 | 42192060740 | 40 CUP, UNIT-DOSE in 1 CASE (42192-607-40) / 5 mL in 1 CUP, UNIT-DOSE (42192-607-05) | | 2016-09-21 | 2026-07-31 | No | No | Current |