gavreto

Generic: pralsetinib

Labeler: genentech, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name gavreto
Generic Name pralsetinib
Labeler genentech, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

pralsetinib 100 mg/1

Manufacturer
Genentech, Inc.

Identifiers & Regulatory

Product NDC 50242-210
Product ID 50242-210_202f12fc-4f57-4e69-bf7b-73d7c1d1ed0c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA213721
Marketing Start 2021-07-01
Marketing End 2026-09-30

Pharmacologic Class

Established (EPC)
kinase inhibitor [epc]
Mechanism of Action
rearranged during transfection (ret) inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50242210
Hyphenated Format 50242-210

Supplemental Identifiers

RxCUI
2394941 2394947
UNII
1WPE73O1WV
NUI
N0000175605 N0000193947

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name gavreto (source: ndc)
Generic Name pralsetinib (source: ndc)
Application Number NDA213721 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (50242-210-60) / 60 CAPSULE in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (50242-210-83) / 60 CAPSULE in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (50242-210-90) / 90 CAPSULE in 1 BOTTLE
source: ndc

Packages (3)

50242-210-60 1 BOTTLE in 1 CARTON (50242-210-60) / 60 CAPSULE in 1 BOTTLE 50242-210-83 1 BOTTLE in 1 CARTON (50242-210-83) / 60 CAPSULE in 1 BOTTLE 50242-210-90 1 BOTTLE in 1 CARTON (50242-210-90) / 90 CAPSULE in 1 BOTTLE

Ingredients (1)

pralsetinib (100 mg/1)

Linked Drug Pages (1)

Gavreto ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "202f12fc-4f57-4e69-bf7b-73d7c1d1ed0c", "openfda": {"nui": ["N0000175605", "N0000193947"], "unii": ["1WPE73O1WV"], "rxcui": ["2394941", "2394947"], "spl_set_id": ["59984249-e3ff-4f97-8d7a-c1a905d604a8"], "pharm_class_epc": ["Kinase Inhibitor [EPC]"], "pharm_class_moa": ["Rearranged during Transfection (RET) Inhibitors [MoA]"], "manufacturer_name": ["Genentech, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (50242-210-60)  / 60 CAPSULE in 1 BOTTLE", "package_ndc": "50242-210-60", "marketing_end_date": "20260930", "marketing_start_date": "20210701"}, {"sample": true, "description": "1 BOTTLE in 1 CARTON (50242-210-83)  / 60 CAPSULE in 1 BOTTLE", "package_ndc": "50242-210-83", "marketing_end_date": "20260930", "marketing_start_date": "20210701"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (50242-210-90)  / 90 CAPSULE in 1 BOTTLE", "package_ndc": "50242-210-90", "marketing_end_date": "20260930", "marketing_start_date": "20210701"}], "brand_name": "Gavreto", "product_id": "50242-210_202f12fc-4f57-4e69-bf7b-73d7c1d1ed0c", "dosage_form": "CAPSULE", "pharm_class": ["Kinase Inhibitor [EPC]", "Rearranged during Transfection (RET) Inhibitors [MoA]"], "product_ndc": "50242-210", "generic_name": "Pralsetinib", "labeler_name": "Genentech, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gavreto", "active_ingredients": [{"name": "PRALSETINIB", "strength": "100 mg/1"}], "application_number": "NDA213721", "marketing_category": "NDA", "marketing_end_date": "20260930", "marketing_start_date": "20210701"}