NUCYNTA
- Product NDC
- 21695-069
- 11-digit product format
- 216950069
- Labeler code
- 21695
- Product ID
- 21695-069_7997e6da-7e98-4520-9d1b-0b8341bac64a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- tapentadol hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Rebel Distributors Corp
- Application
- NDA022304
- Marketing category
- NDA
- Marketing start
- 2009-06-01
- Marketing end
- 0000-00-00
- Substance
- TAPENTADOL HYDROCHLORIDE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Opioid Agonist [EPC],Opioid Agonists [MoA]
- DEA schedule
- CII
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 21695-069-72 | NUCYNTA | 120 in 1 BOTTLE | TABLET, FILM COATED | 120 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| tapentadol hydrochloride | ACTIVE INGREDIENT | 71204KII53 | NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| tapentadol | ACTIVE MOIETY | H8A007M585 | NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| aluminum oxide | INACTIVE INGREDIENT | LMI26O6933 | NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| croscarmellose sodium | INACTIVE INGREDIENT | M28OL1HH48 | NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| lactose monohydrate | INACTIVE INGREDIENT | EWQ57Q8I5X | NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| polyethylene glycol | INACTIVE INGREDIENT | 3WJQ0SDW1A | NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| polyvinyl alcohol | INACTIVE INGREDIENT | 532B59J990 | NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| povidone | INACTIVE INGREDIENT | FZ989GH94E | NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| talc | INACTIVE INGREDIENT | 7SEV7J4R1U | NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 21695-069 | NUCYNTA (TAPENTADOL HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] | 1 | Legacy NDC, 1 package rows | 20110805_7997e6da-7e98-4520-9d1b-0b8341bac64a.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 21695-069-72 | 21695006972 | 120 in 1 BOTTLE | Historical |