Tramadol Hydrochloride and Acetaminophen
- Product NDC
- 70518-4461
- 11-digit product format
- 705184461
- Labeler code
- 70518
- Product ID
- 70518-4461_3d6eccec-e115-1d20-e063-6294a90ac7d9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tramadol Hydrochloride and Acetaminophen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA207152
- Marketing category
- ANDA
- Marketing start
- 2025-08-28
- 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 |
|---|
| 70518-4461-0 | Tramadol Hydrochloride and Acetaminophen | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 60 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-4461-0 | 70518446100 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4461-0) | 2025-08-28 | No | No | Historical |