Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide
- Product NDC
- 0527-5302
- 11-digit product format
- 005275302
- Labeler code
- 0527
- Product ID
- 0527-5302_56788119-a0d4-4e78-8900-41c2416bbc92
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- brompheniramine maleate, pseudoephedrine hydrochloride and dextromethorphan hydrobromide
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- Lannett Company, Inc.
- Application
- ANDA213125
- Marketing category
- ANDA
- Marketing start
- 2020-04-17
- Marketing end
- 2023-12-31
- 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 |
|---|
| 0527-5302-64 | 00527530264 | 118 mL in 1 BOTTLE, PLASTIC (0527-5302-64) | 118 ml | 2020-04-17 | 2023-12-31 | No | No | Current |
| 0527-5302-70 | 00527530270 | 473 mL in 1 BOTTLE, PLASTIC (0527-5302-70) | 473 ml | 2020-04-17 | 2023-08-31 | No | No | Current |