INLYTA
- Product NDC
- 63539-026
- 11-digit product format
- 635390026
- Labeler code
- 63539
- Product ID
- 63539-026_0c63e82e-8c0d-4177-8748-20c2ece2b5e6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- axitinib
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- U.S. Pharmaceuticals
- Application
- NDA202324
- Marketing category
- NDA
- Marketing start
- 2012-01-27
- Substance
- AXITINIB
- Active strength
- 1 mg/1
- Pharmacologic classes
- Kinase Inhibitor [EPC], Receptor Tyrosine Kinase 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
- INLYTA
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AXITINIB | 1 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | C9LVQ0YUXG |
| Rxcui | 1243004, 1243010, 1243012, 1243014 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63539-026-01 | INLYTA | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 12 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| AXITINIB | ACTIVE INGREDIENT | C9LVQ0YUXG | INLYTA (AXITINIB) TABLET, FILM COATED [U.S. PHARMACEUTICALS] | 3 | |
| AXITINIB | ACTIVE MOIETY | C9LVQ0YUXG | INLYTA (AXITINIB) TABLET, FILM COATED [U.S. PHARMACEUTICALS] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | INLYTA (AXITINIB) TABLET, FILM COATED [U.S. PHARMACEUTICALS] | 3 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | INLYTA (AXITINIB) TABLET, FILM COATED [U.S. PHARMACEUTICALS] | 3 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | INLYTA (AXITINIB) TABLET, FILM COATED [U.S. PHARMACEUTICALS] | 3 | |
| HYPROMELLOSE 2910 (15000 MPA.S) | INACTIVE INGREDIENT | 288VBX44JC | INLYTA (AXITINIB) TABLET, FILM COATED [U.S. PHARMACEUTICALS] | 3 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | INLYTA (AXITINIB) TABLET, FILM COATED [U.S. PHARMACEUTICALS] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | INLYTA (AXITINIB) TABLET, FILM COATED [U.S. PHARMACEUTICALS] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | INLYTA (AXITINIB) TABLET, FILM COATED [U.S. PHARMACEUTICALS] | 3 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | INLYTA (AXITINIB) TABLET, FILM COATED [U.S. PHARMACEUTICALS] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63539-026 | INLYTA (AXITINIB) TABLET, FILM COATED [U.S. PHARMACEUTICALS] | 11 | Current NDC, Legacy NDC, 1 package rows | 20250101_8a903e31-936e-4ed7-8a59-59f32374f338.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 |
|---|
| 63539-026-01 | 63539002601 | 90 TABLET, FILM COATED in 1 BOTTLE (63539-026-01) | 2012-01-27 | 0000-00-00 | Yes | No | Current |