Prescription drug · NDA
Rezlidhia (Olutasidenib) NDC 71332-005
Olutasidenib 150 mg/1 · Capsule · Oral · Rigel Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71332-005-01 | 71332000501 | 30 CAPSULE in 1 BOTTLE (71332-005-01)Marketed from Dec 1, 2022 |
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)
- Rezlidhia
- Generic name (nonproprietary)
- olutasidenib
- Active ingredients
- Olutasidenib — 150 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Rigel Pharmaceuticals, Inc.NDC labeler code 71332
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 215814
- Marketing start
- Listing expires
- Identifiers
- Product ID 71332-005_6df73356-e3c1-498d-af08-c34b5d257bdbSPL ID 6df73356-e3c1-498d-af08-c34b5d257bdbSPL set ID 4a0c7c8b-b95f-455d-9600-b7351e4397feRxCUI 2623648, 2623654UNII 0T4IMT8S5Z
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
N471332000501followed by a unit qualifier and the quantityPackage 71332-0005-01. 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)
Relapsed or Refractory Acute Myeloid Leukemia REZLIDHIA is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test [see Dosage and Administration ( 2.1 ), Clinical Pharmacology ( 12.1 ), and Clinical Studies ( 14.1 )] . REZLIDHIA is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 71332-005
- What is NDC 71332-005?
- 71332-005 is the product NDC for Rezlidhia (olutasidenib), Olutasidenib 150 mg/1 capsule, listed with the FDA by Rigel Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Rezlidhia (Olutasidenib).
- What is the active ingredient?
- Olutasidenib.
- Who is the labeler?
- Rigel Pharmaceuticals, Inc., NDC labeler code 71332. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Rezlidhia?
- 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.