SOTYKTU
- Product NDC
- 0003-0895
- 11-digit product format
- 000030895
- Labeler code
- 0003
- Product ID
- 0003-0895_9d2e509f-3c81-45c7-984b-4e3c8b56dbef
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- deucravacitinib
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- E.R. Squibb & Sons, L.L.C.
- Application
- NDA214958
- Marketing category
- NDA
- Marketing start
- 2022-09-09
- Substance
- DEUCRAVACITINIB
- Active strength
- 6 mg/1
- Pharmacologic classes
- Tyrosine Kinase 2 Inhibitor [EPC], Tyrosine Kinase 2 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- SOTYKTU
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DEUCRAVACITINIB | 6 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | N0A21N6RAU |
| Rxcui | 2612092, 2612098 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0003-0895-11 | SOTYKTU | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | | 2 |
| 0003-0895-91 | SOTYKTU | 30 in 1 BLISTER PACK | TABLET, FILM COATED | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0003-0895 | SOTYKTU (DEUCRAVACITINIB) TABLET, FILM COATED [E.R. SQUIBB & SONS, L.L.C.] | 1 | Current NDC, Legacy NDC, 2 package rows | 20220921_ff4d7258-5068-4cdf-9692-8cae04c3198e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0003-0895-11 | 00003089511 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0003-0895-11) | 2022-09-09 | 0000-00-00 | No | No | Current |
| 0003-0895-91 | 00003089591 | 30 TABLET, FILM COATED in 1 BLISTER PACK (0003-0895-91) | 2022-09-09 | 0000-00-00 | Yes | No | Current |