TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
- Product NDC
- 76420-105
- 11-digit product format
- 764200105
- Labeler code
- 76420
- Product ID
- 76420-105_b2ddcdd0-7229-99df-e053-2a95a90a8818
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA201952
- Marketing category
- ANDA
- Marketing start
- 2012-12-15
- 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 |
|---|
| 76420-105-01 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 1 in 1 BOTTLE | TABLET, FILM COATED | 1 | | 1 |
| 76420-105-02 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 2 in 1 BOTTLE | TABLET, FILM COATED | 2 | | 1 |
| 76420-105-03 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 3 in 1 BOTTLE | TABLET, FILM COATED | 3 | | 1 |
| 76420-105-10 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 10 in 1 BOTTLE | TABLET, FILM COATED | 10 | | 1 |
| 76420-105-30 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76420-105 | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN (TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN) TABLET, FILM COATED [ASCLEMED USA, INC.] | 1 | Current NDC, Legacy NDC, 5 package rows | 20201104_82d8b70f-aebf-4b9a-89b1-183fc9e2ff59.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 76420-105-01 | 76420010501 | 1 TABLET, FILM COATED in 1 BOTTLE (76420-105-01) | 2020-10-30 | 0000-00-00 | No | No | Current |
| 76420-105-02 | 76420010502 | 2 TABLET, FILM COATED in 1 BOTTLE (76420-105-02) | 2020-10-30 | 0000-00-00 | No | No | Current |
| 76420-105-03 | 76420010503 | 3 TABLET, FILM COATED in 1 BOTTLE (76420-105-03) | 2020-10-30 | 0000-00-00 | No | No | Current |
| 76420-105-10 | 76420010510 | 10 TABLET, FILM COATED in 1 BOTTLE (76420-105-10) | 2020-10-30 | 0000-00-00 | No | No | Current |
| 76420-105-30 | 76420010530 | 30 TABLET, FILM COATED in 1 BOTTLE (76420-105-30) | 2020-10-30 | 0000-00-00 | No | No | Current |