Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide
- Product NDC
- 51991-847
- 11-digit product format
- 519910847
- Labeler code
- 51991
- Product ID
- 51991-847_c04e190e-1aad-4b53-825a-9e9c14a4b490
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, and DEXTROMETHORPHAN HYDROBROMIDE
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- Breckenridge Pharmaceutical, Inc.
- Application
- ANDA203997
- Marketing category
- ANDA
- Marketing start
- 2020-09-30
- Marketing end
- 2022-12-31
- Substance
- BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
- Active strength
- 2 mg/5mL; mg/5mL; mg/5mL
- Pharmacologic classes
- Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC],Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 51991-847-04 | 51991084704 | 118 mL in 1 BOTTLE (51991-847-04) | 118 ml | 2020-09-30 | 0000-00-00 | No | No | Current |
| 51991-847-16 | 51991084716 | 473 mL in 1 BOTTLE (51991-847-16) | 473 ml | 2020-09-30 | 0000-00-00 | No | No | Current |