Promethazine with Codeine
- Product NDC
- 0121-0928
- 11-digit product format
- 001210928
- Labeler code
- 0121
- Product ID
- 0121-0928_d5c9a447-d506-eee6-e053-2a95a90a389d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Promethazine Hydrochloride and Codeine Phosphate
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Pharmaceutical Associates, Inc.
- Application
- ANDA040650
- Marketing category
- ANDA
- Marketing start
- 2020-09-18
- Marketing end
- 0000-00-00
- Substance
- CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE
- Active strength
- 10 mg/5mL; mg/5mL
- Pharmacologic classes
- Full Opioid Agonists [MoA], Opioid Agonist [EPC], Phenothiazine [EPC], Phenothiazines [CS]
- DEA schedule
- CV
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- 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 |
|---|
| 0121-0928-16 | 00121092816 | 473 mL in 1 BOTTLE (0121-0928-16) | 473 ml | 2020-09-18 | 0000-00-00 | No | No | Current |