FDA.reportPublic FDA data

Gavreto

Product NDC
50242-210
11-digit product format
502420210
Labeler code
50242
Product ID
50242-210_202f12fc-4f57-4e69-bf7b-73d7c1d1ed0c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pralsetinib
Dosage form
CAPSULE
Route
ORAL
Labeler
Genentech, Inc.
Application
NDA213721
Marketing category
NDA
Marketing start
2021-07-01
Marketing end
2026-09-30
Substance
PRALSETINIB
Active strength
100 mg/1
Pharmacologic classes
Kinase Inhibitor [EPC], Rearranged during Transfection (RET) Inhibitors [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Gavreto

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRALSETINIB100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1WPE73O1WV
Rxcui2394941, 2394947

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
b01d7c5e-8a19-4838-b13a-e7dff83e1be3Product name120210511
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50242-210-12Gavreto120 in 1 BOTTLECAPSULE12018
50242-210-12Gavreto1 in 1 CARTONCAPSULE118
50242-210-60Gavreto60 in 1 BOTTLECAPSULE6018
50242-210-60Gavreto1 in 1 CARTONCAPSULE118
50242-210-83Gavreto1 in 1 CARTONCAPSULE118
50242-210-83Gavreto60 in 1 BOTTLECAPSULE6018
50242-210-90Gavreto90 in 1 BOTTLECAPSULE9018
50242-210-90Gavreto1 in 1 CARTONCAPSULE118

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50242-210-60EA - Each50242-210a842d32a-216b-42d1-bd66-a785f2df9fa612021-06-02
50242-210-90EA - Each50242-210543d1917-f2b6-451d-b199-d966737f329212021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50242-210GAVRETO (PRALSETINIB) CAPSULE [GENENTECH, INC.]16Current NDC, Legacy NDC, 8 package rows20241121_59984249-e3ff-4f97-8d7a-c1a905d604a8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2394947GAVRETO 100 MG Oral CapsulePSN59984249-e3ff-4f97-8d7a-c1a905d604a818
2394941pralsetinib 100 MG Oral CapsulePSN59984249-e3ff-4f97-8d7a-c1a905d604a818
2394947pralsetinib 100 MG Oral Capsule [Gavreto]SBD59984249-e3ff-4f97-8d7a-c1a905d604a818
2394941pralsetinib 100 MG Oral CapsuleSCD59984249-e3ff-4f97-8d7a-c1a905d604a818
2394947Gavreto 100 MG Oral CapsuleSY59984249-e3ff-4f97-8d7a-c1a905d604a818

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50242-210-12502420210121 BOTTLE in 1 CARTON (50242-210-12) > 120 CAPSULE in 1 BOTTLE1 bottle2021-07-010000-00-00NoNoCurrent
50242-210-60502420210601 BOTTLE in 1 CARTON (50242-210-60) / 60 CAPSULE in 1 BOTTLE1 bottle2021-07-012026-09-30NoNoCurrent
50242-210-83502420210831 BOTTLE in 1 CARTON (50242-210-83) / 60 CAPSULE in 1 BOTTLE1 bottle2021-07-012026-09-30YesNoCurrent
50242-210-86502420210861 BOTTLE in 1 CARTON (50242-210-86) > 120 CAPSULE in 1 BOTTLE1 bottle2020-09-150000-00-00YesNoCurrent
50242-210-90502420210901 BOTTLE in 1 CARTON (50242-210-90) / 90 CAPSULE in 1 BOTTLE1 bottle2021-07-012026-09-30NoNoCurrent