Prescription drug · NDA
Idhifa (Enasidenib mesylate) NDC 59572-705
Enasidenib mesylate 50 mg/1 · Tablet, Film coated · Oral · Celgene Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59572-705-30 | 59572070530 | 30 TABLET, FILM COATED in 1 BOTTLE (59572-705-30)Marketed from Aug 1, 2017 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Idhifa
- Generic name (nonproprietary)
- enasidenib mesylate
- Active ingredients
- Enasidenib mesylate — 50 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Celgene CorporationNDC labeler code 59572
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 209606
- Marketing start
- Listing expires
- Other FDA classes
- Isocitrate Dehydrogenase 2 Inhibitors (Mechanism)
- Identifiers
- Product ID 59572-705_32634006-49db-4043-b84b-65f7f54b142dSPL ID 32634006-49db-4043-b84b-65f7f54b142dSPL set ID a5b4cdf0-3fa8-4c6c-80f6-8d8a00e3a5b6RxCUI 1940370, 1940372, 1940374, 1940376UNII UF6PC17XAV
- Pharmacologic class
- Isocitrate Dehydrogenase 2 Inhibitor
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N459572070530followed by a unit qualifier and the quantityPackage 59572-0705-30. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
IDHIFA is an isocitrate dehydrogenase-2 inhibitor indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test ( 1.1 ). 1.1 Acute Myeloid Leukemia IDHIFA is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test.
Excerpt only. Read the full label for complete information.
About NDC 59572-705
- What is NDC 59572-705?
- 59572-705 is the product NDC for Idhifa (enasidenib mesylate), Enasidenib mesylate 50 mg/1 tablet, film coated, listed with the FDA by Celgene Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Idhifa (Enasidenib mesylate).
- What is the active ingredient?
- Enasidenib mesylate.
- Who is the labeler?
- Celgene Corporation, NDC labeler code 59572. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Idhifa?
- 1 other product NDC are listed under this name. See all Idhifa NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Idhifa products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Idhifaenasidenib mesylate | Enasidenib mesylate 100 mg/1 | Tablet, Film coatedOral | Celgene Corporation | 59572-710 | 59572-0710-30 |
Other NDCs under NDA 209606
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Idhifaenasidenib mesylate | Enasidenib mesylate 100 mg/1 | Tablet, Film coatedOral | Celgene Corporation | 59572-710 |