Hydrocodone Bitartrate and Chlorpheniramine Maleate
- Product NDC
- 42192-612
- 11-digit product format
- 421920612
- Labeler code
- 42192
- Product ID
- 42192-612_b3ae852b-4fe5-4ee3-e053-2a95a90a8578
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Chlorpheniramine Maleate
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Acella Pharmaceuticals, LLC
- Application
- ANDA206891
- Marketing category
- ANDA
- Marketing start
- 2017-06-14
- Marketing end
- 0000-00-00
- Substance
- HYDROCODONE BITARTRATE; CHLORPHENIRAMINE MALEATE
- Active strength
- 5 mg/5mL; mg/5mL
- Pharmacologic classes
- Opioid Agonist [EPC],Opioid Agonists [MoA],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]
- DEA schedule
- CII
- 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 |
|---|
| 42192-612-16 | 42192061216 | 480 mL in 1 BOTTLE (42192-612-16) | 480 ml | 2017-06-14 | 0000-00-00 | No | No | Current |