Tramadol Hydrochloride and Acetaminophen
- Product NDC
- 33261-389
- 11-digit product format
- 332610389
- Labeler code
- 33261
- Product ID
- 33261-389_055f642c-a10c-4209-812b-d9f3c1a7816e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tramadol Hydrochloride and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aidarex Pharmaceuticals LLC
- 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
- 2019-12-31
- 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 |
|---|
| 33261-389-00 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-39a0-f424-e053-dadaa90a57ce | Tramadol Hydrochloride and Acetaminophen Tablets, USP |
| 33261-389-02 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-39a0-f424-e053-dadaa90a57ce | Tramadol Hydrochloride and Acetaminophen Tablets, USP |
| 33261-389-20 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-39a0-f424-e053-dadaa90a57ce | Tramadol Hydrochloride and Acetaminophen Tablets, USP |
| 33261-389-30 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-39a0-f424-e053-dadaa90a57ce | Tramadol Hydrochloride and Acetaminophen Tablets, USP |
| 33261-389-40 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-39a0-f424-e053-dadaa90a57ce | Tramadol Hydrochloride and Acetaminophen Tablets, USP |
| 33261-389-60 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-39a0-f424-e053-dadaa90a57ce | Tramadol Hydrochloride and Acetaminophen Tablets, USP |
| 33261-389-90 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-39a0-f424-e053-dadaa90a57ce | Tramadol Hydrochloride and Acetaminophen Tablets, USP |
| 33261-389-98 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-39a0-f424-e053-dadaa90a57ce | Tramadol Hydrochloride and Acetaminophen Tablets, USP |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 33261-389-00 | Tramadol Hydrochloride and Acetaminophen | 100 in 1 BOTTLE | TABLET | 100 | | 3 |
| 33261-389-02 | Tramadol Hydrochloride and Acetaminophen | 120 in 1 BOTTLE | TABLET | 120 | | 3 |
| 33261-389-20 | Tramadol Hydrochloride and Acetaminophen | 20 in 1 BOTTLE | TABLET | 20 | | 3 |
| 33261-389-30 | Tramadol Hydrochloride and Acetaminophen | 30 in 1 BOTTLE | TABLET | 30 | | 3 |
| 33261-389-40 | Tramadol Hydrochloride and Acetaminophen | 40 in 1 BOTTLE | TABLET | 40 | | 3 |
| 33261-389-60 | Tramadol Hydrochloride and Acetaminophen | 60 in 1 BOTTLE | TABLET | 60 | | 3 |
| 33261-389-90 | Tramadol Hydrochloride and Acetaminophen | 90 in 1 BOTTLE | TABLET | 90 | | 3 |
| 33261-389-98 | Tramadol Hydrochloride and Acetaminophen | 168 in 1 BOTTLE | TABLET | 168 | | 3 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 33261-389 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [AIDAREX PHARMACEUTICALS LLC] | 3 | Legacy NDC, 8 package rows | 20141023_76444c7e-ff07-4032-92fe-dd8a2208ab55.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 33261-389-00 | 33261038900 | 100 in 1 BOTTLE | Historical |
| 33261-389-02 | 33261038902 | 120 in 1 BOTTLE | Historical |
| 33261-389-20 | 33261038920 | 20 in 1 BOTTLE | Historical |
| 33261-389-30 | 33261038930 | 30 in 1 BOTTLE | Historical |
| 33261-389-40 | 33261038940 | 40 in 1 BOTTLE | Historical |
| 33261-389-60 | 33261038960 | 60 in 1 BOTTLE | Historical |
| 33261-389-90 | 33261038990 | 90 in 1 BOTTLE | Historical |
| 33261-389-98 | 33261038998 | 168 in 1 BOTTLE | Historical |