Promethazine with Codeine
- Product NDC
- 68071-1606
- 11-digit product format
- 680711606
- Labeler code
- 68071
- Product ID
- 68071-1606_575c4df3-e5ff-0def-e053-2a91aa0afa51
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Promethazine Hydrochloride and Codeine Phosphate
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA040650
- Marketing category
- ANDA
- Marketing start
- 2006-01-31
- Marketing end
- 0000-00-00
- Substance
- PROMETHAZINE HYDROCHLORIDE; CODEINE PHOSPHATE
- Active strength
- 6 mg/5mL; mg/5mL
- Pharmacologic classes
- Phenothiazine [EPC],Phenothiazines [CS],Full Opioid Agonists [MoA],Opioid Agonist [EPC]
- DEA schedule
- CV
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record