PROMETHAZINE DM
- Product NDC
- 68071-1643
- 11-digit product format
- 680711643
- Labeler code
- 68071
- Product ID
- 68071-1643_bb12571f-4748-7083-e053-2a95a90a344b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dextromethorphan Hydrobromide and Promethazine Hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA040649
- Marketing category
- ANDA
- Marketing start
- 2006-02-14
- Marketing end
- 0000-00-00
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE
- Active strength
- 15 mg/5mL; mg/5mL
- Pharmacologic classes
- Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA],Phenothiazine [EPC],Phenothiazines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68071-1643-4 | 68071164304 | 120 mL in 1 BOTTLE (68071-1643-4) | 120 ml | 2017-09-14 | 0000-00-00 | No | No | Current |