Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 76420-876
- 11-digit product format
- 764200876
- Labeler code
- 76420
- Product ID
- 76420-876_338382b0-08f4-67b8-e063-6294a90a0da4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA202214
- Marketing category
- ANDA
- Marketing start
- 2014-10-06
- Substance
- ACETAMINOPHEN; HYDROCODONE BITARTRATE
- Active strength
- 325; 7.5 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 | 7.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, NO70W886KK |
| Rxcui | 856999, 857002, 857005 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76420-876-00 | Hydrocodone Bitartrate and Acetaminophen | 1000 in 1 BOTTLE, PLASTIC | TABLET | 1000 | | 3 |
| 76420-876-01 | Hydrocodone Bitartrate and Acetaminophen | 1 in 1 BOTTLE, PLASTIC | TABLET | 1 | | 3 |
| 76420-876-03 | Hydrocodone Bitartrate and Acetaminophen | 3 in 1 BOTTLE, PLASTIC | TABLET | 3 | | 3 |
| 76420-876-05 | Hydrocodone Bitartrate and Acetaminophen | 500 in 1 BOTTLE, PLASTIC | TABLET | 500 | | 3 |
| 76420-876-07 | Hydrocodone Bitartrate and Acetaminophen | 7 in 1 BOTTLE, PLASTIC | TABLET | 7 | | 3 |
| 76420-876-10 | Hydrocodone Bitartrate and Acetaminophen | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | | 3 |
| 76420-876-14 | Hydrocodone Bitartrate and Acetaminophen | 14 in 1 BOTTLE, PLASTIC | TABLET | 14 | | 3 |
| 76420-876-20 | Hydrocodone Bitartrate and Acetaminophen | 20 in 1 BOTTLE, PLASTIC | TABLET | 20 | | 3 |
| 76420-876-30 | Hydrocodone Bitartrate and Acetaminophen | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 3 |
| 76420-876-60 | Hydrocodone Bitartrate and Acetaminophen | 60 in 1 BOTTLE, PLASTIC | TABLET | 60 | | 3 |
| 76420-876-90 | Hydrocodone Bitartrate and Acetaminophen | 90 in 1 BOTTLE, PLASTIC | TABLET | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76420-876 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [ASCLEMED USA, INC.] | 3 | Current NDC, 11 package rows | 20250429_ba7d27eb-952d-4e99-95b9-5b0b2f85794b.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 76420-876-00 | 76420087600 | 1000 TABLET in 1 BOTTLE, PLASTIC (76420-876-00) | 1000 tablet | 2024-11-12 | No | No | Historical |
| 76420-876-01 | 76420087601 | 1 TABLET in 1 BOTTLE, PLASTIC (76420-876-01) | 1 tablet | 2024-11-12 | No | No | Historical |
| 76420-876-03 | 76420087603 | 3 TABLET in 1 BOTTLE, PLASTIC (76420-876-03) | 3 tablet | 2024-11-12 | No | No | Historical |
| 76420-876-05 | 76420087605 | 500 TABLET in 1 BOTTLE, PLASTIC (76420-876-05) | 500 tablet | 2024-11-12 | No | No | Historical |
| 76420-876-07 | 76420087607 | 7 TABLET in 1 BOTTLE, PLASTIC (76420-876-07) | 7 tablet | 2024-11-12 | No | No | Historical |
| 76420-876-10 | 76420087610 | 100 TABLET in 1 BOTTLE, PLASTIC (76420-876-10) | 100 tablet | 2024-11-12 | No | No | Historical |
| 76420-876-14 | 76420087614 | 14 TABLET in 1 BOTTLE, PLASTIC (76420-876-14) | 14 tablet | 2024-11-12 | No | No | Historical |
| 76420-876-20 | 76420087620 | 20 TABLET in 1 BOTTLE, PLASTIC (76420-876-20) | 20 tablet | 2024-11-12 | No | No | Historical |
| 76420-876-30 | 76420087630 | 30 TABLET in 1 BOTTLE, PLASTIC (76420-876-30) | 30 tablet | 2024-11-12 | No | No | Historical |
| 76420-876-60 | 76420087660 | 60 TABLET in 1 BOTTLE, PLASTIC (76420-876-60) | 60 tablet | 2024-11-12 | No | No | Historical |
| 76420-876-90 | 76420087690 | 90 TABLET in 1 BOTTLE, PLASTIC (76420-876-90) | 90 tablet | 2024-11-12 | No | No | Historical |