NDC codes

FDA NDC Directory
Product NDC (as listed)71332-005Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71332-0005Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
71332-005-017133200050130 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

N471332000501 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

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