HYDROCODONE BITARTRATE AND ACETAMINOPHEN
- Product NDC
- 76519-1079
- 11-digit product format
- 765191079
- Labeler code
- 76519
- Product ID
- 76519-1079_76ded294-0797-6c12-e053-2a91aa0a4c4c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- HYDROCODONE BITARTRATE AND ACETAMINOPHEN
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- H.J. Harkins Company, Inc.
- Application
- ANDA090415
- Marketing category
- ANDA
- Marketing start
- 2016-01-28
- Marketing end
- 0000-00-00
- Substance
- ACETAMINOPHEN; HYDROCODONE BITARTRATE
- Active strength
- 300 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
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76519-1079-3 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | 30 in 1 BOTTLE | TABLET | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76519-1079 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [H.J. HARKINS COMPANY, INC.] | 1 | Legacy NDC, 1 package rows | 20181010_76ded294-0796-6c12-e053-2a91aa0a4c4c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 76519-1079-3 | 76519107903 | 30 in 1 BOTTLE | Historical |