Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 63187-838
- 11-digit product format
- 631870838
- Labeler code
- 63187
- Product ID
- 63187-838_4960f0db-c0f1-4d9c-bca7-8e62861fbfc3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA040148
- Marketing category
- ANDA
- Marketing start
- 2014-10-06
- Marketing end
- 0000-00-00
- Substance
- HYDROCODONE BITARTRATE; ACETAMINOPHEN
- Active strength
- 3 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 |
|---|
| 63187-838-12 | 63187083812 | 12 TABLET in 1 BOTTLE, PLASTIC (63187-838-12) | 12 tablet | 2017-05-01 | 0000-00-00 | No | No | Current |
| 63187-838-15 | 63187083815 | 15 TABLET in 1 BOTTLE, PLASTIC (63187-838-15) | 15 tablet | 2017-05-01 | 0000-00-00 | No | No | Current |
| 63187-838-20 | 63187083820 | 20 TABLET in 1 BOTTLE, PLASTIC (63187-838-20) | 20 tablet | 2017-05-01 | 0000-00-00 | No | No | Current |
| 63187-838-30 | 63187083830 | 30 TABLET in 1 BOTTLE, PLASTIC (63187-838-30) | 30 tablet | 2017-05-01 | 0000-00-00 | No | No | Current |
| 63187-838-60 | 63187083860 | 60 TABLET in 1 BOTTLE, PLASTIC (63187-838-60) | 60 tablet | 2017-05-01 | 0000-00-00 | No | No | Current |
| 63187-838-90 | 63187083890 | 90 TABLET in 1 BOTTLE, PLASTIC (63187-838-90) | 90 tablet | 2017-05-01 | 0000-00-00 | No | No | Current |