TAPENTADOL
- Product NDC
- 0054-0942
- 11-digit product format
- 000540942
- Labeler code
- 0054
- Product ID
- 0054-0942_7f43eb28-160b-4256-bde1-ed711407ad01
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tapentadol Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- NDA022304
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2025-12-15
- Substance
- TAPENTADOL HYDROCHLORIDE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Opioid Agonist [EPC], Opioid Agonists [MoA]
- DEA schedule
- CII
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- TAPENTADOL
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TAPENTADOL HYDROCHLORIDE | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 71204KII53 |
| Rxcui | 825409, 825411, 825413 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0054-0942-25 | TAPENTADOL | 100 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 100 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0054-0942-25 | 00054094225 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0054-0942-25) | 2025-12-15 | No | No | Historical |