TAPENTADOL
- Product NDC
- 0054-0936
- 11-digit product format
- 000540936
- Labeler code
- 0054
- Product ID
- 0054-0936_7fef46e2-c049-44d8-962f-fdd233dad041
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tapentadol Hydrochloride
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- NDA200533
- 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 |
|---|---|
| TAPENTADOL HYDROCHLORIDE | 50 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 71204KII53 |
| Rxcui | 1148797, 1148800, 1148803, 1148807, 1148809 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 279f6ab2-ad0d-a4be-abc3-377fa3441fa2 | Product name | 1 | 20140508 |
| 41331914-7851-9471-14c3-fea0cf65689e | Product name | 1 | 20140508 |
| 7142c439-ef45-40fb-d30b-dd20e4faf1c1 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0054-0936-21 | TAPENTADOL | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED, EXTENDED RE | 60 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0054-0936-21 | EA - Each | 0054-0936 | c30e62a2-16cd-469e-b597-e680c00d6612 | 1 | 2026-04-20 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1148797 | tapentadol 100 MG 12HR Extended Release Oral Tablet | PSN | 38de863e-56ff-4c43-9ab8-9b3e1ba82858 | 3 |
| 1148800 | tapentadol 150 MG 12HR Extended Release Oral Tablet | PSN | 38de863e-56ff-4c43-9ab8-9b3e1ba82858 | 3 |
| 1148803 | tapentadol 200 MG 12HR Extended Release Oral Tablet | PSN | 38de863e-56ff-4c43-9ab8-9b3e1ba82858 | 3 |
| 1148807 | tapentadol 250 MG 12HR Extended Release Oral Tablet | PSN | 38de863e-56ff-4c43-9ab8-9b3e1ba82858 | 3 |
| 1148809 | tapentadol 50 MG 12HR Extended Release Oral Tablet | PSN | 38de863e-56ff-4c43-9ab8-9b3e1ba82858 | 3 |
| 1148797 | 12 HR tapentadol 100 MG Extended Release Oral Tablet | SCD | 38de863e-56ff-4c43-9ab8-9b3e1ba82858 | 3 |
| 1148800 | 12 HR tapentadol 150 MG Extended Release Oral Tablet | SCD | 38de863e-56ff-4c43-9ab8-9b3e1ba82858 | 3 |
| 1148803 | 12 HR tapentadol 200 MG Extended Release Oral Tablet | SCD | 38de863e-56ff-4c43-9ab8-9b3e1ba82858 | 3 |
| 1148807 | 12 HR tapentadol 250 MG Extended Release Oral Tablet | SCD | 38de863e-56ff-4c43-9ab8-9b3e1ba82858 | 3 |
| 1148809 | 12 HR tapentadol 50 MG Extended Release Oral Tablet | SCD | 38de863e-56ff-4c43-9ab8-9b3e1ba82858 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 0054-0936-21 | 00054093621 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0054-0936-21) | 2025-12-15 | No | No | Historical |