FDA.reportPublic FDA data

Gilotrif

Product NDC
0597-0138
11-digit product format
005970138
Labeler code
0597
Product ID
0597-0138_3a365319-7ba8-4454-8239-7b0e7ff8a18e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
afatinib
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Boehringer Ingelheim Pharmaceuticals, Inc.
Application
NDA201292
Marketing category
NDA
Marketing start
2013-07-12
Substance
AFATINIB
Active strength
40 mg/1
Pharmacologic classes
Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Gilotrif
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AFATINIB40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii41UD74L59M
Rxcui1430446, 1430449, 1430451, 1430453, 1430455, 1430457

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
89429eeb-a2c7-45de-a004-92a3b584a014Product name120151112

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0597-0138-30Gilotrif1 in 1 CARTONTABLET, FILM COATED120
0597-0138-30Gilotrif30 in 1 BOTTLETABLET, FILM COATED3020
0597-0138-95Gilotrif1 in 1 CARTONTABLET, FILM COATED120
0597-0138-95Gilotrif30 in 1 BOTTLETABLET, FILM COATED3020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0597-0138-30EA - Each0597-01385b8dbb59-8a0b-4d28-892f-aea736d0f61e12013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
afatinibACTIVE INGREDIENT41UD74L59MGILOTRIF (AFATINIB) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]7
afatinibACTIVE MOIETY41UD74L59MGILOTRIF (AFATINIB) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0597-0138GILOTRIF (AFATINIB) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]19Current NDC, Legacy NDC, 4 package rows20241003_fd638e5e-8032-e7ca-0179-95e96ab5d387.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1430446afatinib 20 MG Oral TabletPSNfd638e5e-8032-e7ca-0179-95e96ab5d38720
1430451afatinib 30 MG Oral TabletPSNfd638e5e-8032-e7ca-0179-95e96ab5d38720
1430455afatinib 40 MG Oral TabletPSNfd638e5e-8032-e7ca-0179-95e96ab5d38720
1430449Gilotrif 20 MG Oral TabletPSNfd638e5e-8032-e7ca-0179-95e96ab5d38720
1430453Gilotrif 30 MG Oral TabletPSNfd638e5e-8032-e7ca-0179-95e96ab5d38720
1430457Gilotrif 40 MG Oral TabletPSNfd638e5e-8032-e7ca-0179-95e96ab5d38720
1430449afatinib 20 MG Oral Tablet [Gilotrif]SBDfd638e5e-8032-e7ca-0179-95e96ab5d38720
1430453afatinib 30 MG Oral Tablet [Gilotrif]SBDfd638e5e-8032-e7ca-0179-95e96ab5d38720
1430457afatinib 40 MG Oral Tablet [Gilotrif]SBDfd638e5e-8032-e7ca-0179-95e96ab5d38720
1430446afatinib 20 MG Oral TabletSCDfd638e5e-8032-e7ca-0179-95e96ab5d38720
1430451afatinib 30 MG Oral TabletSCDfd638e5e-8032-e7ca-0179-95e96ab5d38720
1430455afatinib 40 MG Oral TabletSCDfd638e5e-8032-e7ca-0179-95e96ab5d38720
1430446afatinib 20 MG (as afatinib dimaleate 29.56 MG) Oral TabletSYfd638e5e-8032-e7ca-0179-95e96ab5d38720
1430451afatinib 30 MG (as afatinib dimaleate 44.34 MG) Oral TabletSYfd638e5e-8032-e7ca-0179-95e96ab5d38720
1430455afatinib 40 MG (as afatinib dimaleate 59.12 MG) Oral TabletSYfd638e5e-8032-e7ca-0179-95e96ab5d38720
1430449Gilotrif 20 MG (as afatinib dimaleate 29.56 MG) Oral TabletSYfd638e5e-8032-e7ca-0179-95e96ab5d38720
1430449Gilotrif 20 MG Oral TabletSYfd638e5e-8032-e7ca-0179-95e96ab5d38720
1430453Gilotrif 30 MG (as afatinib dimaleate 44.34 MG) Oral TabletSYfd638e5e-8032-e7ca-0179-95e96ab5d38720
1430453Gilotrif 30 MG Oral TabletSYfd638e5e-8032-e7ca-0179-95e96ab5d38720
1430457Gilotrif 40 MG (as afatinib dimaleate 59.12 MG) Oral TabletSYfd638e5e-8032-e7ca-0179-95e96ab5d38720
1430457Gilotrif 40 MG Oral TabletSYfd638e5e-8032-e7ca-0179-95e96ab5d38720

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0597-0138-30005970138301 BOTTLE in 1 CARTON (0597-0138-30) / 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2013-08-080000-00-00NoNoCurrent
0597-0138-95005970138951 BOTTLE in 1 CARTON (0597-0138-95) / 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2013-08-082027-04-30YesNoCurrent