Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 51655-804
- 11-digit product format
- 516550804
- Labeler code
- 51655
- Product ID
- 51655-804_2dddb4be-83ee-0cbe-e054-00144ff88e88
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Northwind Pharmaceuticals
- Application
- ANDA201013
- Marketing category
- ANDA
- Marketing start
- 2015-07-31
- 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
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
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NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51655-804 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [NORTHWIND PHARMACEUTICALS] | 1 | Legacy NDC | 20160314_2dddb4be-83ed-0cbe-e054-00144ff88e88.zip |