Prescription drug · NDA
Gavreto (Pralsetinib) NDC 50242-210
Pralsetinib 100 mg/1 · Capsule · Oral · Genentech, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50242-210-60 | 50242021060 | 1 BOTTLE in 1 CARTON (50242-210-60) / 60 CAPSULE in 1 BOTTLEMarketed from Jul 1, 2021 | |
| 50242-210-83 | 50242021083 | 1 BOTTLE in 1 CARTON (50242-210-83) / 60 CAPSULE in 1 BOTTLEMarketed from Jul 1, 2021 · Sample package | |
| 50242-210-90 | 50242021090 | 1 BOTTLE in 1 CARTON (50242-210-90) / 90 CAPSULE in 1 BOTTLEMarketed from Jul 1, 2021 |
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
- Genentech, Inc.NDC labeler code 50242
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 213721
- Marketing start
- Marketing end
- Other FDA classes
- Rearranged during Transfection (RET) Inhibitors (Mechanism)
- Identifiers
- Product ID 50242-210_202f12fc-4f57-4e69-bf7b-73d7c1d1ed0cSPL ID 202f12fc-4f57-4e69-bf7b-73d7c1d1ed0cSPL set ID 59984249-e3ff-4f97-8d7a-c1a905d604a8RxCUI 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
N450242021060followed by a unit qualifier and the quantityPackage 50242-0210-60. 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 .
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 50242-210
- What is NDC 50242-210?
- 50242-210 is the product NDC for Gavreto (pralsetinib), Pralsetinib 100 mg/1 capsule, listed with the FDA by Genentech, 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?
- Genentech, Inc., NDC labeler code 50242. 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?
- 1 other product NDC are listed under this name. See all Gavreto NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Gavreto products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Gavretopralsetinib | Pralsetinib 100 mg/1 | CapsuleOral | Rigel Pharmaceuticals, Inc. | 71332-006 | 71332-0006-1271332-0006-6071332-0006-90 |
Other NDCs under NDA 213721
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Gavretopralsetinib | Pralsetinib 100 mg/1 | CapsuleOral | Rigel Pharmaceuticals, Inc. | 71332-006 |