Bromfed DM
- Product NDC
- 68025-002
- 11-digit product format
- 680250002
- Labeler code
- 68025
- Product ID
- 68025-002_ed39203a-d496-c2f1-e053-2995a90a1f3c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- Vertical Pharmaceuticals, LLC
- Application
- ANDA203375
- Marketing category
- ANDA
- Marketing start
- 2022-12-31
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68025-002-04 | 68025000204 | 118 mL in 1 BOTTLE, PLASTIC (68025-002-04) | 118 ml | 2022-12-31 | 0000-00-00 | No | No | Current |
| 68025-002-16 | 68025000216 | 473 mL in 1 BOTTLE, PLASTIC (68025-002-16) | 473 ml | 2022-12-31 | 0000-00-00 | No | No | Current |