Tramadol/APAP
- Product NDC
- 72189-671
- 11-digit product format
- 721890671
- Labeler code
- 72189
- Product ID
- 72189-671_4f1b668e-fb85-43a0-e063-6294a90af3ef
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tramadol/APAP
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Direct_rx
- Application
- ANDA090485
- Marketing category
- ANDA
- Marketing start
- 2026-03-30
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Tramadol/APAP
- Listing expiration
- 2027-12-31
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 |
|---|
| 72189-671-60 | Tramadol/APAP | 60 in 1 BOTTLE | TABLET | 60 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 72189-671-60 | 72189067160 | 60 TABLET in 1 BOTTLE (72189-671-60) | 60 tablet | 2026-03-30 | No | No | Current |