Tramadol Hydrochloride and Acetaminophen
- Product NDC
- 68788-7855
- 11-digit product format
- 687887855
- Labeler code
- 68788
- Product ID
- 68788-7855_1aba4d2b-98ce-454e-8828-59c3a70627d7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tramadol Hydrochloride and Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA090485
- Marketing category
- ANDA
- Marketing start
- 2021-01-29
- 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 |
|---|
| ACETAMINOPHEN | 325 mg/1 |
| TRAMADOL HYDROCHLORIDE | 37.5 mg/1 |
Harmonized Identifiers
| Field | Values |
|---|
| Unii | 362O9ITL9D, 9N7R477WCK |
| Rxcui | 836395 |
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 | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68788-7855-2 | 68788785502 | 20 TABLET in 1 BOTTLE (68788-7855-2) | 20 tablet | 2021-01-29 | 0000-00-00 | No | No | Current |
| 68788-7855-3 | 68788785503 | 30 TABLET in 1 BOTTLE (68788-7855-3) | 30 tablet | 2021-01-29 | 0000-00-00 | No | No | Current |
| 68788-7855-9 | 68788785509 | 90 TABLET in 1 BOTTLE (68788-7855-9) | 90 tablet | 2021-01-29 | 0000-00-00 | No | No | Current |