brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromide
- Product NDC
- 51862-535
- 11-digit product format
- 518620535
- Labeler code
- 51862
- Product ID
- 51862-535_e2c0e6b2-e69b-0439-e053-2995a90ac2f1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromide
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- Mayne Pharma
- Application
- ANDA207676
- Marketing category
- ANDA
- Marketing start
- 2019-02-06
- Marketing end
- 2022-08-31
- Substance
- BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
- Active strength
- 2 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
- 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 |
|---|
| 51862-535-04 | 51862053504 | 118 mL in 1 BOTTLE, PLASTIC (51862-535-04) | 118 ml | 2019-02-06 | 0000-00-00 | No | No | Current |
| 51862-535-16 | 51862053516 | 473 mL in 1 BOTTLE, PLASTIC (51862-535-16) | 473 ml | 2019-02-06 | 0000-00-00 | No | No | Current |