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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N201292-001GILOTRIFAFATINIB DIMALEATEEQ 20MG BASETABLET / ORALRLD2013-07-12
N201292-002GILOTRIFAFATINIB DIMALEATEEQ 30MG BASETABLET / ORALRLD2013-07-12
N201292-003GILOTRIFAFATINIB DIMALEATEEQ 40MG BASETABLET / ORALRLD, RS2013-07-12

Orange Book patents#

Current patent rows page 1 of 1 · 30 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N201292-001RE434312026-01-13Drug substance2013-08-01
N201292-001RE43431*PED2026-07-13Pediatric extension
N201292-00195392582026-11-09U-19502017-02-02
N201292-0019539258*PED2027-05-09Pediatric extension
N201292-00184265862029-10-10Drug substance2013-08-01
N201292-00185458842029-12-19Drug product2013-10-28
N201292-0018426586*PED2030-04-10Pediatric extension
N201292-0018545884*PED2030-06-19Pediatric extension
N201292-001100047432030-07-05Drug product2018-08-02
N201292-00110004743*PED2031-01-05Pediatric extension
N201292-002RE434312026-01-13Drug substance2013-08-01
N201292-002RE43431*PED2026-07-13Pediatric extension
N201292-00295392582026-11-09U-19502017-02-02
N201292-0029539258*PED2027-05-09Pediatric extension
N201292-00284265862029-10-10Drug substance2013-08-01
N201292-00285458842029-12-19Drug product2013-10-28
N201292-0028426586*PED2030-04-10Pediatric extension
N201292-0028545884*PED2030-06-19Pediatric extension
N201292-002100047432030-07-05Drug product2018-08-02
N201292-00210004743*PED2031-01-05Pediatric extension
N201292-003RE434312026-01-13Drug substance2013-08-01
N201292-003RE43431*PED2026-07-13Pediatric extension
N201292-00395392582026-11-09U-19502017-02-02
N201292-0039539258*PED2027-05-09Pediatric extension
N201292-00384265862029-10-10Drug substance2013-08-01
N201292-00385458842029-12-19Drug product2013-10-28
N201292-0038426586*PED2030-04-10Pediatric extension
N201292-0038545884*PED2030-06-19Pediatric extension
N201292-003100047432030-07-05Drug product2018-08-02
N201292-00310004743*PED2031-01-05Pediatric extension

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N201292-001GILOTRIFEQ 20MG BASETABLET / ORALRLD2013-07-12a50c72e98297…
2026-08-01 22:54:322026-06N201292-002GILOTRIFEQ 30MG BASETABLET / ORALRLD2013-07-12a50c72e98297…
2026-08-01 22:54:322026-06N201292-003GILOTRIFEQ 40MG BASETABLET / ORALRLD, RS2013-07-12a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N201292-001RE434312026-01-13Drug substance2013-08-01a50c72e98297…
2026-08-01 22:54:322026-06N201292-001RE43431*PED2026-07-13Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N201292-00195392582026-11-09U-19502017-02-02a50c72e98297…
2026-08-01 22:54:322026-06N201292-0019539258*PED2027-05-09Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N201292-00184265862029-10-10Drug substance2013-08-01a50c72e98297…
2026-08-01 22:54:322026-06N201292-00185458842029-12-19Drug product2013-10-28a50c72e98297…
2026-08-01 22:54:322026-06N201292-0018426586*PED2030-04-10Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N201292-0018545884*PED2030-06-19Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N201292-001100047432030-07-05Drug product2018-08-02a50c72e98297…
2026-08-01 22:54:322026-06N201292-00110004743*PED2031-01-05Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N201292-002RE434312026-01-13Drug substance2013-08-01a50c72e98297…
2026-08-01 22:54:322026-06N201292-002RE43431*PED2026-07-13Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N201292-00295392582026-11-09U-19502017-02-02a50c72e98297…
2026-08-01 22:54:322026-06N201292-0029539258*PED2027-05-09Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N201292-00284265862029-10-10Drug substance2013-08-01a50c72e98297…
2026-08-01 22:54:322026-06N201292-00285458842029-12-19Drug product2013-10-28a50c72e98297…
2026-08-01 22:54:322026-06N201292-0028426586*PED2030-04-10Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N201292-0028545884*PED2030-06-19Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N201292-002100047432030-07-05Drug product2018-08-02a50c72e98297…
2026-08-01 22:54:322026-06N201292-00210004743*PED2031-01-05Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N201292-003RE434312026-01-13Drug substance2013-08-01a50c72e98297…
2026-08-01 22:54:322026-06N201292-003RE43431*PED2026-07-13Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N201292-00395392582026-11-09U-19502017-02-02a50c72e98297…
2026-08-01 22:54:322026-06N201292-0039539258*PED2027-05-09Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N201292-00384265862029-10-10Drug substance2013-08-01a50c72e98297…
2026-08-01 22:54:322026-06N201292-00385458842029-12-19Drug product2013-10-28a50c72e98297…
2026-08-01 22:54:322026-06N201292-0038426586*PED2030-04-10Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N201292-0038545884*PED2030-06-19Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N201292-003100047432030-07-05Drug product2018-08-02a50c72e98297…
2026-08-01 22:54:322026-06N201292-00310004743*PED2031-01-05Pediatric extensiona50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GilotrifAFATINIBBoehringer Ingelheim Pharmaceuticals, Inc.fd638e5e-8032-e7ca-0179-95e96ab5d3872025-11-13Warnings, Adverse reactionsExact identifier
application applno (NDA): 201292
application number: NDA201292
ndc (product): 0597-0138

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
41UD74L59MInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1430446Internal RxNorm lookup
1430449Internal RxNorm lookup
1430451Internal RxNorm lookup
1430453Internal RxNorm lookup
1430455Internal RxNorm lookup
1430457Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
fd638e5e-8032-e7ca-0179-95e96ab5d387Available on FDA.report

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