NDC codes

FDA NDC Directory
Product NDC (as listed)71332-006Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71332-0006Add 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
71332-006-1271332000612120 CAPSULE in 1 BOTTLE (71332-006-12)Marketed from Jun 24, 2024
71332-006-607133200066060 CAPSULE in 1 BOTTLE (71332-006-60)Marketed from Jun 24, 2024
71332-006-907133200069090 CAPSULE in 1 BOTTLE (71332-006-90)Marketed from Jun 24, 2024

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)
Gavreto
Generic name (nonproprietary)
pralsetinib
Active ingredients
Pralsetinib — 100 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 213721
Marketing start
Listing expires
Other FDA classes
Rearranged during Transfection (RET) Inhibitors (Mechanism)
Identifiers
Product ID 71332-006_af2c2115-cb7d-4679-935a-c2200487b965SPL ID af2c2115-cb7d-4679-935a-c2200487b965SPL set ID 16edd46e-28b8-f06d-e063-6394a90ae31bRxCUI 2394941, 2394947UNII 1WPE73O1WV
Pharmacologic class
Kinase 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

N471332000612 followed by a unit qualifier and the quantity

Package 71332-0006-12. 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)

GAVRETO is a kinase inhibitor indicated for treatment of: Adult patients with metastatic rearranged during transfection (RET ) fusion-positive non-small cell lung cancer as detected by an FDA approved test (NSCLC). ( 1.1 ) Adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71332-006

What is NDC 71332-006?
71332-006 is the product NDC for Gavreto (pralsetinib), Pralsetinib 100 mg/1 capsule, listed with the FDA by Rigel Pharmaceuticals, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Gavreto (Pralsetinib).
What is the active ingredient?
Pralsetinib.
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 Gavreto?
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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