Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 63304-497
- 11-digit product format
- 633040497
- Labeler code
- 63304
- Product ID
- 63304-497_4f875c7a-4454-45a2-bf55-fcc2932c51db
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA040826
- Marketing category
- ANDA
- Marketing start
- 2018-07-31
- Substance
- ACETAMINOPHEN; HYDROCODONE BITARTRATE
- Active strength
- 325; 10 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 | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, NO70W886KK |
| Rxcui | 856999 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63304-497-01 | Hydrocodone Bitartrate and Acetaminophen | 100 in 1 BOTTLE | TABLET | 100 | | 12 |
| 63304-497-03 | Hydrocodone Bitartrate and Acetaminophen | 10 in 1 BOTTLE | TABLET | 10 | | 12 |
| 63304-497-05 | Hydrocodone Bitartrate and Acetaminophen | 500 in 1 BOTTLE | TABLET | 500 | | 12 |
| 63304-497-10 | Hydrocodone Bitartrate and Acetaminophen | 1000 in 1 BOTTLE | TABLET | 1000 | | 12 |
| 63304-497-11 | Hydrocodone Bitartrate and Acetaminophen | 1 in 1 BLISTER PACK | TABLET | 1 | | 12 |
| 63304-497-69 | Hydrocodone Bitartrate and Acetaminophen | 10 in 1 CARTON | TABLET | 10 | | 12 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63304-497 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 12 | Current NDC, Legacy NDC, 6 package rows | 20180731_6e153073-ca78-481e-9e9c-0365ee3f3d59.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 |
|---|
| 63304-497-01 | 63304049701 | 100 TABLET in 1 BOTTLE (63304-497-01) | 100 tablet | 2018-07-31 | 0000-00-00 | No | No | Current |
| 63304-497-03 | 63304049703 | 10 TABLET in 1 BOTTLE (63304-497-03) | 10 tablet | 2018-07-31 | 0000-00-00 | No | No | Current |
| 63304-497-05 | 63304049705 | 500 TABLET in 1 BOTTLE (63304-497-05) | 500 tablet | 2018-07-31 | 0000-00-00 | No | No | Current |
| 63304-497-10 | 63304049710 | 1000 TABLET in 1 BOTTLE (63304-497-10) | 1000 tablet | 2018-07-31 | 0000-00-00 | No | No | Current |
| 63304-497-11 | 63304049711 | 1 in 1 BLISTER PACK | | | | | | Historical |
| 63304-497-69 | 63304049769 | 10 BLISTER PACK in 1 CARTON (63304-497-69) / 1 TABLET in 1 BLISTER PACK (63304-497-11) | 10 blister pack | 2018-07-31 | 0000-00-00 | No | No | Current |