Nucynta
- Product NDC
- 24510-100
- 11-digit product format
- 245100100
- Labeler code
- 24510
- Product ID
- 24510-100_3f155622-a850-4d63-9539-9e645a8fcc28
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tapentadol hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Collegium Pharmaceutical, Inc.
- Application
- NDA022304
- Marketing category
- NDA
- Marketing start
- 2019-04-01
- 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
- Nucynta
- 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, 854140, 854142, 854144 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 24510-100-01 | Nucynta | 10 in 1 CARTON | TABLET, FILM COATED | 10 | | 7 |
| 24510-100-01 | Nucynta | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 7 |
| 24510-100-10 | Nucynta | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 24510-100 | NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [COLLEGIUM PHARMACEUTICAL, INC.] | 6 | Current NDC, Legacy NDC, 3 package rows | 20231223_80938c30-9fe3-4c7d-9d9c-5476638cfb2d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 24510-100-01 | 24510010001 | 10 BLISTER PACK in 1 CARTON (24510-100-01) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 10 blister pack | 2019-04-01 | 0000-00-00 | No | No | Current |
| 24510-100-10 | 24510010010 | 100 TABLET, FILM COATED in 1 BOTTLE (24510-100-10) | | 2019-04-01 | 0000-00-00 | No | No | Current |