Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 50268-401
- 11-digit product format
- 502680401
- Labeler code
- 50268
- Product ID
- 50268-401_41b02c81-db6d-b522-e063-6394a90abb86
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- AvPAK
- Application
- ANDA040736
- Marketing category
- ANDA
- Marketing start
- 2014-09-15
- Substance
- ACETAMINOPHEN; HYDROCODONE BITARTRATE
- Active strength
- 325; 5 mg/1; mg/1
- Pharmacologic classes
- Opioid Agonist [EPC], Opioid Agonists [MoA]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Hydrocodone Bitartrate and Acetaminophen
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 325 mg/1 |
| HYDROCODONE BITARTRATE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, NO70W886KK |
| Rxcui | 856999, 857002 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50268-401-11 | Hydrocodone Bitartrate and Acetaminophen | 1 in 1 BLISTER PACK | TABLET | 1 | | 8 |
| 50268-401-15 | Hydrocodone Bitartrate and Acetaminophen | 50 in 1 BOX, UNIT-DOSE | TABLET | 50 | | 8 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50268-401 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [AVPAK] | 7 | Current NDC, Legacy NDC, 2 package rows | 20240110_5174bd9a-b777-a6e3-f72f-c16082ee67d3.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50268-401-11 | 50268040111 | 1 in 1 BLISTER PACK | | | | | | Historical |
| 50268-401-15 | 50268040115 | 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-401-15) / 1 TABLET in 1 BLISTER PACK (50268-401-11) | 50 blister pack | 2014-09-15 | 0000-00-00 | No | No | Current |