Home NDC 0597-0145 Ofev
Product NDC 0597-0145
11-digit product format 005970145
Labeler code 0597
Product ID 0597-0145_5c860918-0d7e-4aaf-b103-85f66e9dcdbe
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name nintedanib
Dosage form CAPSULE
Route ORAL
Labeler Boehringer Ingelheim Pharmaceuticals, Inc.
Application NDA205832
Marketing category NDA
Marketing start 2014-10-15
Substance NINTEDANIB ESYLATE
Active strength 150 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N205832-001 OFEV NINTEDANIB ESYLATE EQ 100MG BASE CAPSULE / ORAL AB RLD 2014-10-15 N205832-002 OFEV NINTEDANIB ESYLATE EQ 150MG BASE CAPSULE / ORAL AB RLD, RS 2014-10-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 16 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N205832-001 6762180 2025-10-01 Drug substance, Drug product 2014-10-22 N205832-001 10154990 2026-01-08 U-2620 2019-09-18 N205832-001 6762180*PED 2026-04-01 Pediatric extension N205832-001 10154990*PED 2026-07-08 Pediatric extension N205832-001 10105323 2029-06-04 Drug product 2018-11-06 N205832-001 9907756 2029-06-07 Drug product 2018-04-04 N205832-001 10105323*PED 2029-12-04 Pediatric extension N205832-001 9907756*PED 2029-12-07 Pediatric extension N205832-002 6762180 2025-10-01 Drug substance, Drug product 2014-10-22 N205832-002 10154990 2026-01-08 U-2620 2019-09-18 N205832-002 6762180*PED 2026-04-01 Pediatric extension N205832-002 10154990*PED 2026-07-08 Pediatric extension N205832-002 10105323 2029-06-04 Drug product 2018-11-06 N205832-002 9907756 2029-06-07 Drug product 2018-04-04 N205832-002 10105323*PED 2029-12-04 Pediatric extension N205832-002 9907756*PED 2029-12-07 Pediatric extension
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 4 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 3 · 86 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 N205832-001 OFEV EQ 100MG BASE CAPSULE / ORAL AB RLD 2014-10-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205832-002 OFEV EQ 150MG BASE CAPSULE / ORAL AB RLD, RS 2014-10-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 N205832-001 OFEV EQ 100MG BASE CAPSULE / ORAL AB RLD 2014-10-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205832-002 OFEV EQ 150MG BASE CAPSULE / ORAL AB RLD, RS 2014-10-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N205832-001 OFEV EQ 100MG BASE CAPSULE / ORAL RLD 2014-10-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205832-002 OFEV EQ 150MG BASE CAPSULE / ORAL RLD, RS 2014-10-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205832-001 OFEV EQ 100MG BASE CAPSULE / ORAL RLD 2014-10-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205832-002 OFEV EQ 150MG BASE CAPSULE / ORAL RLD, RS 2014-10-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205832-001 OFEV EQ 100MG BASE CAPSULE / ORAL RLD 2014-10-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205832-002 OFEV EQ 150MG BASE CAPSULE / ORAL RLD, RS 2014-10-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205832-001 OFEV EQ 100MG BASE CAPSULE / ORAL RLD 2014-10-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205832-002 OFEV EQ 150MG BASE CAPSULE / ORAL RLD, RS 2014-10-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205832-001 OFEV EQ 100MG BASE CAPSULE / ORAL RLD 2014-10-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205832-002 OFEV EQ 150MG BASE CAPSULE / ORAL RLD, RS 2014-10-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205832-001 OFEV EQ 100MG BASE CAPSULE / ORAL RLD 2014-10-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205832-002 OFEV EQ 150MG BASE CAPSULE / ORAL RLD, RS 2014-10-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205832-001 OFEV EQ 100MG BASE CAPSULE / ORAL RLD 2014-10-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205832-002 OFEV EQ 150MG BASE CAPSULE / ORAL RLD, RS 2014-10-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205832-001 OFEV EQ 100MG BASE CAPSULE / ORAL RLD 2014-10-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205832-002 OFEV EQ 150MG BASE CAPSULE / ORAL RLD, RS 2014-10-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205832-001 OFEV EQ 100MG BASE CAPSULE / ORAL RLD 2014-10-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205832-002 OFEV EQ 150MG BASE CAPSULE / ORAL RLD, RS 2014-10-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N205832-001 OFEV EQ 100MG BASE CAPSULE / ORAL RLD 2014-10-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N205832-002 OFEV EQ 150MG BASE CAPSULE / ORAL RLD, RS 2014-10-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205832-001 OFEV EQ 100MG BASE CAPSULE / ORAL RLD 2014-10-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205832-002 OFEV EQ 150MG BASE CAPSULE / ORAL RLD, RS 2014-10-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205832-001 OFEV EQ 100MG BASE CAPSULE / ORAL RLD 2014-10-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205832-002 OFEV EQ 150MG BASE CAPSULE / ORAL RLD, RS 2014-10-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N205832-001 OFEV EQ 100MG BASE CAPSULE / ORAL RLD 2014-10-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N205832-002 OFEV EQ 150MG BASE CAPSULE / ORAL RLD, RS 2014-10-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N205832-001 OFEV EQ 100MG BASE CAPSULE / ORAL RLD 2014-10-15 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N205832-002 OFEV EQ 150MG BASE CAPSULE / ORAL RLD, RS 2014-10-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N205832-001 OFEV EQ 100MG BASE CAPSULE / ORAL RLD 2014-10-15 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N205832-002 OFEV EQ 150MG BASE CAPSULE / ORAL RLD, RS 2014-10-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N205832-001 OFEV EQ 100MG BASE CAPSULE / ORAL RLD 2014-10-15 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N205832-002 OFEV EQ 150MG BASE CAPSULE / ORAL RLD, RS 2014-10-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N205832-001 OFEV EQ 100MG BASE CAPSULE / ORAL RLD 2014-10-15 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N205832-002 OFEV EQ 150MG BASE CAPSULE / ORAL RLD, RS 2014-10-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N205832-001 OFEV EQ 100MG BASE CAPSULE / ORAL RLD 2014-10-15 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N205832-002 OFEV EQ 150MG BASE CAPSULE / ORAL RLD, RS 2014-10-15 74a2ff9319b5…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 15 · 586 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 N205832-001 6762180 2025-10-01 Drug substance, Drug product 2014-10-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205832-001 10154990 2026-01-08 U-2620 2019-09-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205832-001 6762180*PED 2026-04-01 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205832-001 10154990*PED 2026-07-08 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205832-001 10105323 2029-06-04 Drug product 2018-11-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205832-001 9907756 2029-06-07 Drug product 2018-04-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205832-001 10105323*PED 2029-12-04 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205832-001 9907756*PED 2029-12-07 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205832-002 6762180 2025-10-01 Drug substance, Drug product 2014-10-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205832-002 10154990 2026-01-08 U-2620 2019-09-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205832-002 6762180*PED 2026-04-01 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205832-002 10154990*PED 2026-07-08 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205832-002 10105323 2029-06-04 Drug product 2018-11-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205832-002 9907756 2029-06-07 Drug product 2018-04-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205832-002 10105323*PED 2029-12-04 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N205832-002 9907756*PED 2029-12-07 Pediatric extension 84e616aacf4f…2026-08-18 06:07:40 2026-07 N205832-001 6762180 2025-10-01 Drug substance, Drug product 2014-10-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205832-001 10154990 2026-01-08 U-2620 2019-09-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205832-001 6762180*PED 2026-04-01 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205832-001 10154990*PED 2026-07-08 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205832-001 10105323 2029-06-04 Drug product 2018-11-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205832-001 9907756 2029-06-07 Drug product 2018-04-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205832-001 10105323*PED 2029-12-04 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205832-001 9907756*PED 2029-12-07 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205832-002 6762180 2025-10-01 Drug substance, Drug product 2014-10-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205832-002 10154990 2026-01-08 U-2620 2019-09-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205832-002 6762180*PED 2026-04-01 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205832-002 10154990*PED 2026-07-08 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205832-002 10105323 2029-06-04 Drug product 2018-11-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205832-002 9907756 2029-06-07 Drug product 2018-04-04 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205832-002 10105323*PED 2029-12-04 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N205832-002 9907756*PED 2029-12-07 Pediatric extension caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N205832-001 6762180 2025-10-01 Drug substance, Drug product 2014-10-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205832-001 10154990 2026-01-08 U-2620 2019-09-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205832-001 6762180*PED 2026-04-01 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205832-001 10154990*PED 2026-07-08 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205832-001 10105323 2029-06-04 Drug product 2018-11-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205832-001 9907756 2029-06-07 Drug product 2018-04-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205832-001 10105323*PED 2029-12-04 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205832-001 9907756*PED 2029-12-07 Pediatric extension 011fe1cb6892…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 6 · 222 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Ofev
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NINTEDANIB ESYLATE 150 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 42F62RTZ4G Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1592742 Internal RxNorm lookup 1592748 Internal RxNorm lookup 1592750 Internal RxNorm lookup 1592752 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 0597-0145-60 Ofev 60 in 1 BOTTLE CAPSULE 60 21 0597-0145-60 Ofev 1 in 1 CARTON CAPSULE 1 21
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0597-0145 OFEV (NINTEDANIB) CAPSULE [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.] 20 Current NDC, Legacy NDC, 2 package rows 20250523_da1c9f37-779e-4682-816f-93d0faa4cfc9.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 Ofev NINTEDANIB Boehringer Ingelheim Pharmaceuticals, Inc. da1c9f37-779e-4682-816f-93d0faa4cfc9 2025-11-20 Warnings, Adverse reactions Exact identifier application applno (NDA): 205832 application number: NDA205832 ndc (product): 0597-0145
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 0597-0145-60 00597014560 1 BOTTLE in 1 CARTON (0597-0145-60) / 60 CAPSULE in 1 BOTTLE 1 bottle 2014-10-17 0000-00-00 No No Current