Prescription drug · NDA
Gavreto (Pralsetinib) NDC 71332-006
Pralsetinib 100 mg/1 · Capsule · Oral · Rigel Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71332-006-12 | 71332000612 | 120 CAPSULE in 1 BOTTLE (71332-006-12)Marketed from Jun 24, 2024 | |
| 71332-006-60 | 71332000660 | 60 CAPSULE in 1 BOTTLE (71332-006-60)Marketed from Jun 24, 2024 | |
| 71332-006-90 | 71332000690 | 90 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
N471332000612followed by a unit qualifier and the quantityPackage 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.
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.