Hydrocodone Bitartrate and Acetaminophen
- Product NDC
- 50090-4065
- 11-digit product format
- 500904065
- Labeler code
- 50090
- Product ID
- 50090-4065_bcc670a9-8b5a-420a-846e-2972eff7d2a1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydrocodone Bitartrate and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA202991
- Marketing category
- ANDA
- Marketing start
- 2016-04-12
- Marketing end
- 0000-00-00
- Substance
- HYDROCODONE BITARTRATE; ACETAMINOPHEN
- Active strength
- 5 mg/1; mg/1
- Pharmacologic classes
- Opioid Agonist [EPC],Opioid Agonists [MoA]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 50090-4065-0 | 2023-01-30 | C162847 | 48780-1 | f386c64a-3b05-0266-e053-dadaa90a7c1a | Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/325 mg, 7.5 mg/325 mg, 10 mg/325 mg |
| 50090-4065-1 | 2023-01-30 | C162847 | 48780-1 | f386c64a-3b05-0266-e053-dadaa90a7c1a | Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/325 mg, 7.5 mg/325 mg, 10 mg/325 mg |
| 50090-4065-5 | 2023-01-30 | C162847 | 48780-1 | f386c64a-3b05-0266-e053-dadaa90a7c1a | Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/325 mg, 7.5 mg/325 mg, 10 mg/325 mg |
| 50090-4065-7 | 2023-01-30 | C162847 | 48780-1 | f386c64a-3b05-0266-e053-dadaa90a7c1a | Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/325 mg, 7.5 mg/325 mg, 10 mg/325 mg |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-4065-0 | Hydrocodone Bitartrate and Acetaminophen | 20 in 1 BOTTLE | TABLET | 20 | | 3 |
| 50090-4065-1 | Hydrocodone Bitartrate and Acetaminophen | 10 in 1 BOTTLE, PLASTIC | TABLET | 10 | | 3 |
| 50090-4065-5 | Hydrocodone Bitartrate and Acetaminophen | 15 in 1 BOTTLE, PLASTIC | TABLET | 15 | | 3 |
| 50090-4065-7 | Hydrocodone Bitartrate and Acetaminophen | 12 in 1 BOTTLE, PLASTIC | TABLET | 12 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-4065 | HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLET [A-S MEDICATION SOLUTIONS] | 3 | Legacy NDC, 4 package rows | 20190501_80e0b507-af29-4b01-83b1-a6a421e8b171.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 |
|---|
| 50090-4065-0 | 50090406500 | 20 TABLET in 1 BOTTLE (50090-4065-0) | 20 tablet | 2019-01-17 | 0000-00-00 | No | No | Current |
| 50090-4065-1 | 50090406501 | 10 TABLET in 1 BOTTLE, PLASTIC (50090-4065-1) | 10 tablet | 2016-04-12 | 0000-00-00 | No | No | Current |
| 50090-4065-5 | 50090406505 | 15 TABLET in 1 BOTTLE, PLASTIC (50090-4065-5) | 15 tablet | 2016-04-12 | 0000-00-00 | No | No | Current |
| 50090-4065-7 | 50090406507 | 12 TABLET in 1 BOTTLE, PLASTIC (50090-4065-7) | 12 tablet | 2016-04-12 | 0000-00-00 | No | No | Current |