Tapentadol Hydrochloride
- Product NDC
- 42806-628
- 11-digit product format
- 428060628
- Labeler code
- 42806
- Product ID
- 42806-628_120aa46b-8c91-4460-8e91-85cbaac53d20
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Tapentadol Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- EPIC PHARMA LLC
- Application
- ANDA214378
- Marketing category
- ANDA
- Marketing start
- 2021-12-31
- Substance
- TAPENTADOL HYDROCHLORIDE
- Active strength
- 100 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 Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TAPENTADOL HYDROCHLORIDE | 100 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 |
|---|
| 42806-628-01 | Tapentadol Hydrochloride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 9 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 42806-628-01 | 42806062801 | 100 TABLET, FILM COATED in 1 BOTTLE (42806-628-01) | 2021-12-31 | No | No | Current |