Promethazine with Codeine
- Product NDC
- 68788-9895
- 11-digit product format
- 687889895
- Labeler code
- 68788
- Product ID
- 68788-9895_1d555654-c225-4f84-9894-24aaff1d3b34
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Promethazine Hydrochloride and Codeine Phosphate
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals, Inc
- Application
- ANDA040650
- Marketing category
- ANDA
- Marketing start
- 2012-02-14
- 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
- 2021-12-31
- 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 |
|---|
| 68788-9895-1 | 68788989501 | 118 mL in 1 BOTTLE (68788-9895-1) | 118 ml | 2012-02-14 | 0000-00-00 | No | No | Current |