Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 71205-660
- 11-digit product format
- 712050660
- Labeler code
- 71205
- Product ID
- 71205-660_c6210466-5feb-45d9-b637-b3f482bc3c2b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA211487
- Marketing category
- ANDA
- Marketing start
- 2018-11-08
- 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 |
|---|
| 71205-660-30 | Hydrocodone Bitartrate and Acetaminophen | 30 in 1 BOTTLE | TABLET | 30 | | 1 |
| 71205-660-60 | Hydrocodone Bitartrate and Acetaminophen | 60 in 1 BOTTLE | TABLET | 60 | | 1 |
| 71205-660-90 | Hydrocodone Bitartrate and Acetaminophen | 90 in 1 BOTTLE | TABLET | 90 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71205-660 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [PROFICIENT RX LP] | 1 | Current NDC, Legacy NDC, 3 package rows | 20220519_c6210466-5feb-45d9-b637-b3f482bc3c2b.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 |
|---|
| 71205-660-30 | 71205066030 | 30 TABLET in 1 BOTTLE (71205-660-30) | 30 tablet | 2022-05-16 | 0000-00-00 | No | No | Current |
| 71205-660-60 | 71205066060 | 60 TABLET in 1 BOTTLE (71205-660-60) | 60 tablet | 2022-05-16 | 0000-00-00 | No | No | Current |
| 71205-660-90 | 71205066090 | 90 TABLET in 1 BOTTLE (71205-660-90) | 90 tablet | 2022-05-16 | 0000-00-00 | No | No | Current |