Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 0254-2035
- 11-digit product format
- 002542035
- Labeler code
- 0254
- Product ID
- 0254-2035_2ec6751e-3479-4bef-a1fb-42b30c837186
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Par Pharmaceutical, Inc.
- Application
- ANDA202935
- Marketing category
- ANDA
- Marketing start
- 2018-10-05
- Marketing end
- 0000-00-00
- Substance
- HYDROCODONE BITARTRATE; ACETAMINOPHEN
- Active strength
- 8 mg/1; mg/1
- Pharmacologic classes
- Opioid Agonist [EPC],Opioid Agonists [MoA]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- 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 |
|---|
| 0254-2035-01 | 00254203501 | 100 TABLET in 1 BOTTLE (0254-2035-01) | 100 tablet | 2018-10-05 | 0000-00-00 | No | No | Current |