Tramadol Hydrochloride and Acetaminophen
- Product NDC
- 50090-0919
- 11-digit product format
- 500900919
- Labeler code
- 50090
- Product ID
- 50090-0919_4be26612-6d5b-45cf-b954-a80c37762e39
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tramadol Hydrochloride and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA090485
- Marketing category
- ANDA
- Marketing start
- 2009-12-17
- Marketing end
- 0000-00-00
- Substance
- TRAMADOL HYDROCHLORIDE; ACETAMINOPHEN
- Active strength
- 38 mg/1; mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA],Opioid Agonist [EPC]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- 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 |
|---|
| 50090-0919-0 | 2023-01-30 | C162847 | 48780-1 | f386c64a-3e49-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE and ACETAMINOPHEN TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE and ACETAMINOPHEN TABLETS. TRAMADOL HYDROCHLORIDE and ACETAMINOPHEN tablets, for oral use, C-IV Initial U.S. Approval: 2001 |
| 50090-0919-1 | 2023-01-30 | C162847 | 48780-1 | f386c64a-3e49-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE and ACETAMINOPHEN TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE and ACETAMINOPHEN TABLETS. TRAMADOL HYDROCHLORIDE and ACETAMINOPHEN tablets, for oral use, C-IV Initial U.S. Approval: 2001 |
| 50090-0919-2 | 2023-01-30 | C162847 | 48780-1 | f386c64a-3e49-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE and ACETAMINOPHEN TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE and ACETAMINOPHEN TABLETS. TRAMADOL HYDROCHLORIDE and ACETAMINOPHEN tablets, for oral use, C-IV Initial U.S. Approval: 2001 |
| 50090-0919-3 | 2023-01-30 | C162847 | 48780-1 | f386c64a-3e49-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE and ACETAMINOPHEN TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE and ACETAMINOPHEN TABLETS. TRAMADOL HYDROCHLORIDE and ACETAMINOPHEN tablets, for oral use, C-IV Initial U.S. Approval: 2001 |
| 50090-0919-4 | 2023-01-30 | C162847 | 48780-1 | f386c64a-3e49-0266-e053-dadaa90a7c1a | These highlights do not include all the information needed to use TRAMADOL HYDROCHLORIDE and ACETAMINOPHEN TABLETS safely and effectively. See full prescribing information for TRAMADOL HYDROCHLORIDE and ACETAMINOPHEN TABLETS. TRAMADOL HYDROCHLORIDE and ACETAMINOPHEN tablets, for oral use, C-IV Initial U.S. Approval: 2001 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-0919-0 | Tramadol Hydrochloride and Acetaminophen | 20 in 1 BOTTLE | TABLET | 20 | | 8 |
| 50090-0919-1 | Tramadol Hydrochloride and Acetaminophen | 30 in 1 BOTTLE | TABLET | 30 | | 8 |
| 50090-0919-2 | Tramadol Hydrochloride and Acetaminophen | 60 in 1 BOTTLE | TABLET | 60 | | 8 |
| 50090-0919-3 | Tramadol Hydrochloride and Acetaminophen | 120 in 1 BOTTLE | TABLET | 120 | | 8 |
| 50090-0919-4 | Tramadol Hydrochloride and Acetaminophen | 90 in 1 BOTTLE | TABLET | 90 | | 8 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-0919 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [A-S MEDICATION SOLUTIONS] | 8 | Legacy NDC, 5 package rows | 20210219_2014e1b4-4c8d-4909-ad16-21d89925bf55.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 |
|---|
| 50090-0919-0 | 50090091900 | 20 TABLET in 1 BOTTLE (50090-0919-0) | 20 tablet | 2014-11-28 | 0000-00-00 | No | No | Current |
| 50090-0919-1 | 50090091901 | 30 TABLET in 1 BOTTLE (50090-0919-1) | 30 tablet | 2014-11-28 | 0000-00-00 | No | No | Current |
| 50090-0919-2 | 50090091902 | 60 TABLET in 1 BOTTLE (50090-0919-2) | 60 tablet | 2014-11-28 | 0000-00-00 | No | No | Current |
| 50090-0919-3 | 50090091903 | 120 TABLET in 1 BOTTLE (50090-0919-3) | 120 tablet | 2015-07-14 | 0000-00-00 | No | No | Current |
| 50090-0919-4 | 50090091904 | 90 TABLET in 1 BOTTLE (50090-0919-4) | 90 tablet | 2014-07-08 | 0000-00-00 | No | No | Current |