Idhifa
- Product NDC
- 59572-710
- 11-digit product format
- 595720710
- Labeler code
- 59572
- Product ID
- 59572-710_32634006-49db-4043-b84b-65f7f54b142d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- enasidenib mesylate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Celgene Corporation
- Application
- NDA209606
- Marketing category
- NDA
- Marketing start
- 2017-08-01
- Substance
- ENASIDENIB MESYLATE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Isocitrate Dehydrogenase 2 Inhibitor [EPC], Isocitrate Dehydrogenase 2 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
- Idhifa
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ENASIDENIB MESYLATE | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | UF6PC17XAV |
| Rxcui | 1940370, 1940372, 1940374, 1940376 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59572-710-30 | Idhifa | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 12 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59572-710 | IDHIFA (ENASIDENIB MESYLATE) TABLET, FILM COATED [CELGENE CORPORATION] | 12 | Current NDC, Legacy NDC, 1 package rows | 20250130_a5b4cdf0-3fa8-4c6c-80f6-8d8a00e3a5b6.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 |
|---|
| 59572-710-30 | 59572071030 | 30 TABLET, FILM COATED in 1 BOTTLE (59572-710-30) | 2017-08-01 | 0000-00-00 | No | No | Current |