Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide
- Product NDC
- 42858-320
- 11-digit product format
- 428580320
- Labeler code
- 42858
- Product ID
- 42858-320_e5ff67d3-df79-4fb3-99e9-0e86068756f9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- Rhodes Pharmaceuticals L.P.
- Application
- ANDA202955
- Marketing category
- ANDA
- Marketing start
- 2022-10-12
- Marketing end
- 0000-00-00
- 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
- 2022-12-31
- 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 |
|---|
| 42858-320-12 | 42858032012 | 118 mL in 1 BOTTLE, PLASTIC (42858-320-12) | 118 ml | 2022-10-12 | 0000-00-00 | No | No | Current |
| 42858-320-16 | 42858032016 | 473 mL in 1 BOTTLE, PLASTIC (42858-320-16) | 473 ml | 2022-10-12 | 0000-00-00 | No | No | Current |