Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 65162-675
- 11-digit product format
- 651620675
- Labeler code
- 65162
- Product ID
- 65162-675_93df7284-cdf5-4ac7-ab4f-3a803339b5f4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA206869
- Marketing category
- ANDA
- Marketing start
- 2015-01-30
- Marketing end
- 0000-00-00
- Substance
- HYDROCODONE BITARTRATE; ACETAMINOPHEN
- Active strength
- 5 mg/1; mg/1
- Pharmacologic classes
- Opioid Agonist [EPC],Opioid Agonists [MoA]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65162-675 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AMNEAL PHARMACEUTICALS LLC] | 32 | Legacy NDC | 20240215_5bd98bb7-0d0e-4f15-9f37-36eb1c5fb89f.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65162-675-10 | 65162067510 | 100 TABLET in 1 BOTTLE (65162-675-10) | 100 tablet | 2015-01-30 | 0000-00-00 | No | No | Current |
| 65162-675-11 | 65162067511 | 1000 TABLET in 1 BOTTLE (65162-675-11) | 1000 tablet | 2015-01-30 | 0000-00-00 | No | No | Current |
| 65162-675-50 | 65162067550 | 500 TABLET in 1 BOTTLE (65162-675-50) | 500 tablet | 2015-01-30 | 0000-00-00 | No | No | Current |