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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 362O9ITL9D | ACETAMINOPHEN | 103-90-2 | ACETAMINOPHEN |
| 9N7R477WCK | TRAMADOL HYDROCHLORIDE | 36282-47-0 | TRAMADOL HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 76420-105-01 | 76420010501 | 1 TABLET, FILM COATED in 1 BOTTLE (76420-105-01) | 2020-10-30 | No | No | Historical |
| 76420-105-02 | 76420010502 | 2 TABLET, FILM COATED in 1 BOTTLE (76420-105-02) | 2020-10-30 | No | No | Historical |
| 76420-105-03 | 76420010503 | 3 TABLET, FILM COATED in 1 BOTTLE (76420-105-03) | 2020-10-30 | No | No | Historical |
| 76420-105-10 | 76420010510 | 10 TABLET, FILM COATED in 1 BOTTLE (76420-105-10) | 2020-10-30 | No | No | Historical |
| 76420-105-30 | 76420010530 | 30 TABLET, FILM COATED in 1 BOTTLE (76420-105-30) | 2020-10-30 | No | No | Historical |