Prescription drug · NDA
Inrebic (Fedratinib hydrochloride) NDC 59572-720
Fedratinib hydrochloride 100 mg/1 · Capsule · Oral · Celgene Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59572-720-12 | 59572072012 | 120 CAPSULE in 1 BOTTLE, PLASTIC (59572-720-12)Marketed from Aug 16, 2019 |
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)
- Inrebic
- Generic name (nonproprietary)
- fedratinib hydrochloride
- Active ingredients
- Fedratinib hydrochloride — 100 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Celgene CorporationNDC labeler code 59572
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 212327
- Marketing start
- Listing expires
- Identifiers
- Product ID 59572-720_c328016b-fc3e-4d6f-99b3-8d2c13b362f3SPL ID c328016b-fc3e-4d6f-99b3-8d2c13b362f3SPL set ID f0f55a2a-4e0c-4cba-8571-03e1424486d7RxCUI 2197495, 2197501UNII UH9J2HBQWJ
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
N459572072012followed by a unit qualifier and the quantityPackage 59572-0720-12. 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)
INREBIC ® is indicated for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF). INREBIC is a kinase inhibitor indicated for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF) ( 1 ).
Excerpt only. Read the full label for complete information.
About NDC 59572-720
- What is NDC 59572-720?
- 59572-720 is the product NDC for Inrebic (fedratinib hydrochloride), Fedratinib hydrochloride 100 mg/1 capsule, 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?
- Inrebic (Fedratinib Hydrochloride).
- What is the active ingredient?
- Fedratinib hydrochloride.
- 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 Inrebic?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.