gavreto

Generic: pralsetinib

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

Drug Facts

Product Profile

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

pralsetinib 100 mg/1

Manufacturer
Rigel Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 71332-006
Product ID 71332-006_af2c2115-cb7d-4679-935a-c2200487b965
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA213721
Listing Expiration 2027-12-31
Marketing Start 2024-06-24

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 71332006
Hyphenated Format 71332-006

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
  • 120 CAPSULE in 1 BOTTLE (71332-006-12)
  • 60 CAPSULE in 1 BOTTLE (71332-006-60)
  • 90 CAPSULE in 1 BOTTLE (71332-006-90)
source: ndc

Packages (3)

71332-006-12 120 CAPSULE in 1 BOTTLE (71332-006-12) 71332-006-60 60 CAPSULE in 1 BOTTLE (71332-006-60) 71332-006-90 90 CAPSULE in 1 BOTTLE (71332-006-90)

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": "af2c2115-cb7d-4679-935a-c2200487b965", "openfda": {"nui": ["N0000175605", "N0000193947"], "unii": ["1WPE73O1WV"], "rxcui": ["2394941", "2394947"], "spl_set_id": ["16edd46e-28b8-f06d-e063-6394a90ae31b"], "pharm_class_epc": ["Kinase Inhibitor [EPC]"], "pharm_class_moa": ["Rearranged during Transfection (RET) Inhibitors [MoA]"], "manufacturer_name": ["Rigel Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 CAPSULE in 1 BOTTLE (71332-006-12)", "package_ndc": "71332-006-12", "marketing_start_date": "20240624"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (71332-006-60)", "package_ndc": "71332-006-60", "marketing_start_date": "20240624"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (71332-006-90)", "package_ndc": "71332-006-90", "marketing_start_date": "20240624"}], "brand_name": "Gavreto", "product_id": "71332-006_af2c2115-cb7d-4679-935a-c2200487b965", "dosage_form": "CAPSULE", "pharm_class": ["Kinase Inhibitor [EPC]", "Rearranged during Transfection (RET) Inhibitors [MoA]"], "product_ndc": "71332-006", "generic_name": "Pralsetinib", "labeler_name": "Rigel Pharmaceuticals, 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_start_date": "20240624", "listing_expiration_date": "20271231"}