CIBINQO
- Product NDC
- 63539-436
- 11-digit product format
- 635390436
- Labeler code
- 63539
- Product ID
- 63539-436_0043f6db-decd-4d53-a301-35f2f7a63664
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- abrocitinib
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- U.S. Pharmaceuticals
- Application
- NDA213871
- Marketing category
- NDA
- Marketing start
- 2022-02-24
- Substance
- ABROCITINIB
- Active strength
- 200 mg/1
- Pharmacologic classes
- Janus Kinase Inhibitor [EPC], Janus Kinase Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- CIBINQO
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ABROCITINIB | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 73SM5SF3OR |
| Rxcui | 2591481, 2591487, 2591489, 2591491, 2591493, 2591495 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63539-436-14 | CIBINQO | 14 in 1 BOTTLE | TABLET, FILM COATED | 14 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63539-436 | CIBINQO (ABROCITINIB) TABLET, FILM COATED [U.S. PHARMACEUTICALS] | 4 | Current NDC, Legacy NDC, 1 package rows | 20250322_16c12a56-4550-414b-ac9d-b785b41fea6b.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 |
|---|
| 63539-436-14 | 63539043614 | 14 TABLET, FILM COATED in 1 BOTTLE (63539-436-14) | 2022-02-24 | 0000-00-00 | Yes | No | Current |