promethazine hydrochloride and codeine phosphate
- Product NDC
- 63187-595
- 11-digit product format
- 631870595
- Labeler code
- 63187
- Product ID
- 63187-595_a2de5680-e2fb-4ad3-8641-298cb93af137
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- promethazine hydrochloride and codeine phosphate
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA090180
- Marketing category
- ANDA
- Marketing start
- 2010-03-17
- 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