Tramadol Hydrochloride and Acetaminophen
- Product NDC
- 76420-983
- 11-digit product format
- 764200983
- Labeler code
- 76420
- Product ID
- 76420-983_d5db9e70-d7a4-462d-e053-2995a90a32be
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tramadol Hydrochloride and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA090485
- Marketing category
- ANDA
- Marketing start
- 2009-12-17
- Substance
- ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE
- Active strength
- 325; 37.5 mg/1; mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA], Opioid Agonist [EPC]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Tramadol Hydrochloride and Acetaminophen
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 325 mg/1 |
| TRAMADOL HYDROCHLORIDE | 37.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, 9N7R477WCK |
| Rxcui | 836395 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76420-983-01 | Tramadol Hydrochloride and Acetaminophen | 1 in 1 BOTTLE | TABLET | 1 | | 1 |
| 76420-983-02 | Tramadol Hydrochloride and Acetaminophen | 2 in 1 BOTTLE | TABLET | 2 | | 1 |
| 76420-983-03 | Tramadol Hydrochloride and Acetaminophen | 3 in 1 BOTTLE | TABLET | 3 | | 1 |
| 76420-983-10 | Tramadol Hydrochloride and Acetaminophen | 10 in 1 BOTTLE | TABLET | 10 | | 1 |
| 76420-983-30 | Tramadol Hydrochloride and Acetaminophen | 30 in 1 BOTTLE | TABLET | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76420-983 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN TABLET [ASCLEMED USA, INC.] | 1 | Current NDC, Legacy NDC, 5 package rows | 20220119_52693021-f60f-43bc-9b05-43db18621346.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 |
|---|
| 76420-983-01 | 76420098301 | 1 TABLET in 1 BOTTLE (76420-983-01) | 1 tablet | 2022-01-14 | 0000-00-00 | No | No | Current |
| 76420-983-02 | 76420098302 | 2 TABLET in 1 BOTTLE (76420-983-02) | 2 tablet | 2022-01-14 | 0000-00-00 | No | No | Current |
| 76420-983-03 | 76420098303 | 3 TABLET in 1 BOTTLE (76420-983-03) | 3 tablet | 2022-01-14 | 0000-00-00 | No | No | Current |
| 76420-983-10 | 76420098310 | 10 TABLET in 1 BOTTLE (76420-983-10) | 10 tablet | 2022-01-14 | 0000-00-00 | No | No | Current |
| 76420-983-30 | 76420098330 | 30 TABLET in 1 BOTTLE (76420-983-30) | 30 tablet | 2022-01-14 | 0000-00-00 | No | No | Current |