Home NDC 0597-0138 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 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N201292-001 GILOTRIF AFATINIB DIMALEATE EQ 20MG BASE TABLET / ORAL AB RLD 2013-07-12 N201292-002 GILOTRIF AFATINIB DIMALEATE EQ 30MG BASE TABLET / ORAL AB RLD 2013-07-12 N201292-003 GILOTRIF AFATINIB DIMALEATE EQ 40MG BASE TABLET / ORAL AB RLD, RS 2013-07-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 30 matching rows.
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.
Product history page 1 of 4 · 129 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N201292-001 GILOTRIF EQ 20MG BASE TABLET / ORAL AB RLD 2013-07-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201292-002 GILOTRIF EQ 30MG BASE TABLET / ORAL AB RLD 2013-07-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201292-003 GILOTRIF EQ 40MG BASE TABLET / ORAL AB RLD, RS 2013-07-12 84e616aacf4f…2026-08-18 06:07:40 2026-07 N201292-001 GILOTRIF EQ 20MG BASE TABLET / ORAL AB RLD 2013-07-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N201292-002 GILOTRIF EQ 30MG BASE TABLET / ORAL AB RLD 2013-07-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N201292-003 GILOTRIF EQ 40MG BASE TABLET / ORAL AB RLD, RS 2013-07-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N201292-001 GILOTRIF EQ 20MG BASE TABLET / ORAL RLD 2013-07-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201292-002 GILOTRIF EQ 30MG BASE TABLET / ORAL RLD 2013-07-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201292-003 GILOTRIF EQ 40MG BASE TABLET / ORAL RLD, RS 2013-07-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201292-001 GILOTRIF EQ 20MG BASE TABLET / ORAL RLD 2013-07-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201292-002 GILOTRIF EQ 30MG BASE TABLET / ORAL RLD 2013-07-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201292-003 GILOTRIF EQ 40MG BASE TABLET / ORAL RLD, RS 2013-07-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N201292-001 GILOTRIF EQ 20MG BASE TABLET / ORAL RLD 2013-07-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N201292-002 GILOTRIF EQ 30MG BASE TABLET / ORAL RLD 2013-07-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N201292-003 GILOTRIF EQ 40MG BASE TABLET / ORAL RLD, RS 2013-07-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201292-001 GILOTRIF EQ 20MG BASE TABLET / ORAL RLD 2013-07-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201292-002 GILOTRIF EQ 30MG BASE TABLET / ORAL RLD 2013-07-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201292-003 GILOTRIF EQ 40MG BASE TABLET / ORAL RLD, RS 2013-07-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N201292-001 GILOTRIF EQ 20MG BASE TABLET / ORAL RLD 2013-07-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N201292-002 GILOTRIF EQ 30MG BASE TABLET / ORAL RLD 2013-07-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N201292-003 GILOTRIF EQ 40MG BASE TABLET / ORAL RLD, RS 2013-07-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N201292-001 GILOTRIF EQ 20MG BASE TABLET / ORAL RLD 2013-07-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N201292-002 GILOTRIF EQ 30MG BASE TABLET / ORAL RLD 2013-07-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N201292-003 GILOTRIF EQ 40MG BASE TABLET / ORAL RLD, RS 2013-07-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N201292-001 GILOTRIF EQ 20MG BASE TABLET / ORAL RLD 2013-07-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N201292-002 GILOTRIF EQ 30MG BASE TABLET / ORAL RLD 2013-07-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N201292-003 GILOTRIF EQ 40MG BASE TABLET / ORAL RLD, RS 2013-07-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N201292-001 GILOTRIF EQ 20MG BASE TABLET / ORAL RLD 2013-07-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N201292-002 GILOTRIF EQ 30MG BASE TABLET / ORAL RLD 2013-07-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N201292-003 GILOTRIF EQ 40MG BASE TABLET / ORAL RLD, RS 2013-07-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N201292-001 GILOTRIF EQ 20MG BASE TABLET / ORAL RLD 2013-07-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N201292-002 GILOTRIF EQ 30MG BASE TABLET / ORAL RLD 2013-07-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N201292-003 GILOTRIF EQ 40MG BASE TABLET / ORAL RLD, RS 2013-07-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N201292-001 GILOTRIF EQ 20MG BASE TABLET / ORAL RLD 2013-07-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N201292-002 GILOTRIF EQ 30MG BASE TABLET / ORAL RLD 2013-07-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N201292-003 GILOTRIF EQ 40MG BASE TABLET / ORAL RLD, RS 2013-07-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N201292-001 GILOTRIF EQ 20MG BASE TABLET / ORAL RLD 2013-07-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N201292-002 GILOTRIF EQ 30MG BASE TABLET / ORAL RLD 2013-07-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N201292-003 GILOTRIF EQ 40MG BASE TABLET / ORAL RLD, RS 2013-07-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N201292-001 GILOTRIF EQ 20MG BASE TABLET / ORAL RLD 2013-07-12 301d65b070ca…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 29 · 1,140 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N201292-001 RE43431 2026-01-13 Drug substance 2013-08-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201292-001 RE43431*PED 2026-07-13 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201292-001 9539258 2026-11-09 U-1950 2017-02-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201292-001 9539258*PED 2027-05-09 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201292-001 8426586 2029-10-10 Drug substance 2013-08-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201292-001 8545884 2029-12-19 Drug product 2013-10-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201292-001 8426586*PED 2030-04-10 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201292-001 8545884*PED 2030-06-19 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201292-001 10004743 2030-07-05 Drug product 2018-08-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201292-001 10004743*PED 2031-01-05 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201292-002 RE43431 2026-01-13 Drug substance 2013-08-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201292-002 RE43431*PED 2026-07-13 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201292-002 9539258 2026-11-09 U-1950 2017-02-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201292-002 9539258*PED 2027-05-09 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201292-002 8426586 2029-10-10 Drug substance 2013-08-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201292-002 8545884 2029-12-19 Drug product 2013-10-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201292-002 8426586*PED 2030-04-10 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201292-002 8545884*PED 2030-06-19 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201292-002 10004743 2030-07-05 Drug product 2018-08-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201292-002 10004743*PED 2031-01-05 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201292-003 RE43431 2026-01-13 Drug substance 2013-08-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201292-003 RE43431*PED 2026-07-13 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201292-003 9539258 2026-11-09 U-1950 2017-02-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201292-003 9539258*PED 2027-05-09 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201292-003 8426586 2029-10-10 Drug substance 2013-08-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201292-003 8545884 2029-12-19 Drug product 2013-10-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201292-003 8426586*PED 2030-04-10 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201292-003 8545884*PED 2030-06-19 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201292-003 10004743 2030-07-05 Drug product 2018-08-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 N201292-003 10004743*PED 2031-01-05 Pediatric extension 84e616aacf4f…2026-08-18 06:07:40 2026-07 N201292-001 RE43431 2026-01-13 Drug substance 2013-08-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N201292-001 RE43431*PED 2026-07-13 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N201292-001 9539258 2026-11-09 U-1950 2017-02-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N201292-001 9539258*PED 2027-05-09 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N201292-001 8426586 2029-10-10 Drug substance 2013-08-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N201292-001 8545884 2029-12-19 Drug product 2013-10-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N201292-001 8426586*PED 2030-04-10 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N201292-001 8545884*PED 2030-06-19 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N201292-001 10004743 2030-07-05 Drug product 2018-08-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N201292-001 10004743*PED 2031-01-05 Pediatric extension caaa826d4ba7…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 14 · 523 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Gilotrif
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AFATINIB 40 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 41UD74L59M Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1430446 Internal RxNorm lookup 1430449 Internal RxNorm lookup 1430451 Internal RxNorm lookup 1430453 Internal RxNorm lookup 1430455 Internal RxNorm lookup 1430457 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0597-0138-30 Gilotrif 1 in 1 CARTON TABLET, FILM COATED 1 20 0597-0138-30 Gilotrif 30 in 1 BOTTLE TABLET, FILM COATED 30 20 0597-0138-95 Gilotrif 1 in 1 CARTON TABLET, FILM COATED 1 20 0597-0138-95 Gilotrif 30 in 1 BOTTLE TABLET, FILM COATED 30 20
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0597-0138 GILOTRIF (AFATINIB) TABLET, FILM COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] 19 Current NDC, Legacy NDC, 4 package rows 20241003_fd638e5e-8032-e7ca-0179-95e96ab5d387.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Gilotrif AFATINIB Boehringer Ingelheim Pharmaceuticals, Inc. fd638e5e-8032-e7ca-0179-95e96ab5d387 2025-11-13 Warnings, Adverse reactions Exact identifier application applno (NDA): 201292 application number: NDA201292 ndc (product): 0597-0138
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0597-0138-30 00597013830 1 BOTTLE in 1 CARTON (0597-0138-30) / 30 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2013-08-08 0000-00-00 No No Current 0597-0138-95 00597013895 1 BOTTLE in 1 CARTON (0597-0138-95) / 30 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2013-08-08 2027-04-30 Yes No Current