nintedanib 100 MG Oral Capsule [Ofev]

RxCUI
1592748
RxNorm name
nintedanib 100 MG Oral Capsule [Ofev]
Display name
OFEV (Oral Pill)
Full name
nintedanib 100 MG Oral Capsule [Ofev]
Term type
SBD
Status
Active
Strength
100 mg
Dose form
Cap
Route
Oral Pill
Updated
2026-10-15 15:44:00

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
122014
Active start
122014
Multiple ingredient
NO
Branded
YES

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
nintedanib esylate100 MG / 1 EACHnintedanibnintedanib

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Oral Capsule316965

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
nintedanib1592737

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STROfev 100 MG (as nintedanib ethanesulfonate 120.4 MG) Oral Capsule1NAMES
RxNorm Namenintedanib 100 MG Oral Capsule [Ofev]1NAMES
RxNorm SynonymOfev 100 MG (as nintedanib ethanesulfonate 120.4 MG) Oral Capsule1NAMES
TTYSBD1ATTRIBUTES
SPL_SET_IDda1c9f37-779e-4682-816f-93d0faa4cfc91CODES
RxCUI15927481CODES
MMSL_CODEBD298951CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
0597-0143-600597-0143Ofev nintedanibBoehringer Ingelheim Pharmaceuticals, Inc.NDA205832

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
NDA2058320597-0143Ofev nintedanibNDABoehringer Ingelheim Pharmaceuticals, Inc.

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 1 matching rows.

NDC11, Source, Active table
NDC11SourceActive
00597014360rxnav_ndcsyes

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OfevNINTEDANIBBoehringer Ingelheim Pharmaceuticals, Inc.da1c9f37-779e-4682-816f-93d0faa4cfc92025-11-20Warnings, Adverse reactionsExact identifier
ndc (package): 0597-0143-60
ndc (product): 0597-0143
ndc11 (package): 00597014360
rxcui: 1592748

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
da1c9f37-779e-4682-816f-93d0faa4cfc9Ofev 100 MG Oral Capsule [PSN] · nintedanib 100 MG Oral Capsule [Ofev] [SBD] · Ofev 100 MG (as nintedanib ethanesulfonate 120.4 MG) Oral Capsule [SY]321These highlights do not include all the information needed to use OFEV safely and effectively. See full prescribing information for OFEV. OFEV ® (nintedanib capsules), for oral use Initial U.S. Approval: 201420251120

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
da1c9f37-779e-4682-816f-93d0faa4cfc9These highlights do not include all the information needed to use OFEV safely and effectively. See full prescribing information for OFEV. OFEV ® (nintedanib capsules), for oral use Initial U.S. Approval: 2014Boehringer Ingelheim Pharmaceuticals, Inc.20251120

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCL01EXOther protein kinase inhibitorsATC1-4nintedanib
FDASPLN0000175605Kinase InhibitorEPChas_epcnintedanib
FDASPLN0000175076Protein Kinase InhibitorsMOAhas_moanintedanib
MEDRTD007211IndolesCHEMhas_ingredientnintedanib
MEDRTD054990Idiopathic Pulmonary FibrosisDISEASEmay_treatnintedanib
MEDRTN0000020000Receptor Tyrosine Kinase InhibitorsMOAhas_moanintedanib
MEDRTN0000175678Decreased Endothelial ProliferationPEhas_penintedanib

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH100 MG
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESNDANDA205832
NAMESPrescribable SynonymOfev 100 MG Oral Capsule
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon