nintedanib 100 MG Oral Capsule

RxCUI: 1592742
RxNorm name: nintedanib 100 MG Oral Capsule
Display name: Nintedanib (Oral Pill)
Full name: nintedanib 100 MG Oral Capsule
Term type: SCD
Status: Active
Strength: 100 mg
Dose form: Cap
Route: Oral Pill
Updated: 2026-10-15 15:43:52

RxNorm Status History#

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

Ingredients And Strength#

Ingredient, Strength, Base table
Ingredient	Strength	Base	Basis of strength
nintedanib esylate	100 MG / 1 EACH	nintedanib	nintedanib

Dose Form Concepts#

Dose form, RxCUI table
Dose form	RxCUI
Oral Capsule	316965

Derived Ingredient Concepts#

Ingredient, RxCUI table
Ingredient	RxCUI
nintedanib	1592737

Source Vocabulary Codes#

Code type, Values, Count table
Code type	Values	Count	Category
PRESCRIBABLE	Y	1	ATTRIBUTES
RXNAV_STR	nintedanib 100 MG Oral Capsule	1	NAMES
RxNorm Name	nintedanib 100 MG Oral Capsule	1	NAMES
RxNorm Synonym	nintedanib 100 MG (as nintedanib ethanesulfonate 120.4 MG) Oral Capsule	1	NAMES
TTY	SCD	1	ATTRIBUTES
SPL_SET_ID	11 linked values 0e12f080-fcb4-465f-b988-4fa2c79f49aa 4d017c42-a823-452d-bc6f-0491dd9823e3 4ecf7f05-4a95-b98c-e063-6394a90ab896 43dae004-eaf6-4411-8c3d-db7ab2c3b41e 60d8104e-cb6c-4f4f-8159-95ed57346ffa 88f8600d-0974-51ca-6f8e-28c48a379e08 751c3473-35d6-47d6-b405-af16a989716c 9925b305-c1fb-43b6-a5fd-e03f14f28e6c 572722d7-338a-e4d2-e063-6394a90a257c b72b26c3-7731-80c0-734b-a5f53a1d89ae b14164fb-0276-4ad1-a5ff-400ab9e292da	11	CODES
RxCUI	1592742	1	CODES
MMSL_CODE	2 linked values BD29895 CD29895	2	CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDC	Product NDC	Name	Labeler	Application
0781-2492-60	0781-2492	nintedanib nintedanib	Sandoz Inc	ANDA216915
33342-550-09	33342-550	Nintedanib esylate Nintedanib esylate	Macleods Pharmaceuticals Limited	ANDA219926
42799-972-01	42799-972	Nintedanib nintedanib	Edenbridge Pharmaceuticals LLC.	ANDA219819
42806-569-60	42806-569	nintedanib nintedanib	EPIC PHARMA LLC	ANDA218472
43598-148-60	43598-148	Nintedanib Nintedanib	Dr. Reddy's Laboratories Inc.	ANDA219283
51407-984-60	51407-984	Nintedanib nintedanib	Golden State Medical Supply, Inc.	ANDA219819
60505-4818-6	60505-4818	Nintedanib Nintedanib	Apotex Corp.	ANDA219227
68462-802-60	68462-802	nintedanib nintedanib	Glenmark Pharmaceuticals Inc., USA	ANDA212555
69097-641-03	69097-641	Nintedanib Nintedanib	Cipla USA Inc.	ANDA212609
73190-096-60	73190-096	nintedanib nintedanib	AvKARE	ANDA212555
76282-786-60	76282-786	Nintedanib Capsules, 100 mg and 150 mg Nintedanib	EXELAN PHARMACEUTICALS INC.	ANDA212609

Drugs@FDA Applications#

Application, NDC, Name table
Application	NDC	Name	Marketing category	Labeler
ANDA216915	0781-2492	nintedanib nintedanib	ANDA	Sandoz Inc
ANDA219926	33342-550	Nintedanib esylate Nintedanib esylate	ANDA	Macleods Pharmaceuticals Limited
ANDA219819	42799-972	Nintedanib nintedanib	ANDA	Edenbridge Pharmaceuticals LLC.
ANDA218472	42806-569	nintedanib nintedanib	ANDA	EPIC PHARMA LLC
ANDA219283	43598-148	Nintedanib Nintedanib	ANDA	Dr. Reddy's Laboratories Inc.
ANDA219227	60505-4818	Nintedanib Nintedanib	ANDA	Apotex Corp.
ANDA212555	68462-802	nintedanib nintedanib	ANDA	Glenmark Pharmaceuticals Inc., USA
ANDA212609	69097-641	Nintedanib Nintedanib	ANDA	Cipla USA Inc.

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 11 matching rows.

NDC11, Source, Active table
NDC11	Source	Active
00781249260	rxnav_ndcs	yes
33342055009	rxnav_ndcs	yes
42799097201	rxnav_ndcs	yes
42806056960	rxnav_ndcs	yes
43598014860	rxnav_ndcs	yes
51407098460	rxnav_ndcs	yes
60505481806	rxnav_ndcs	yes
68462080260	rxnav_ndcs	yes
69097064103	rxnav_ndcs	yes
73190009660	rxnav_ndcs	yes
76282078660	rxnav_ndcs	yes

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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nintedanib esylate	NINTEDANIB ESYLATE	Macleods Pharmaceuticals Limited	9925b305-c1fb-43b6-a5fd-e03f14f28e6c	2026-08-03	Warnings, Adverse reactions	Exact identifier ndc (package): 33342-550-09 ndc (product): 33342-550 ndc11 (package): 33342055009 rxcui: 1592742
Nintedanib	NINTEDANIB	Golden State Medical Supply, Inc.	4ecf7f05-4a95-b98c-e063-6394a90ab896	2026-07-30	Warnings, Adverse reactions	Exact identifier ndc (package): 51407-984-60 ndc (product): 51407-984 ndc11 (package): 51407098460 rxcui: 1592742
Nintedanib	NINTEDANIB	Edenbridge Pharmaceuticals LLC.	43dae004-eaf6-4411-8c3d-db7ab2c3b41e	2026-07-29	Warnings, Adverse reactions	Exact identifier ndc (package): 42799-972-01 ndc (product): 42799-972 ndc11 (package): 42799097201 rxcui: 1592742
nintedanib	NINTEDANIB	AvKARE	572722d7-338a-e4d2-e063-6394a90a257c	2026-07-21	Warnings, Adverse reactions	Exact identifier ndc (package): 73190-096-60 ndc (product): 73190-096 ndc11 (package): 73190009660 rxcui: 1592742
nintedanib	NINTEDANIB	Glenmark Pharmaceuticals Inc., USA	b14164fb-0276-4ad1-a5ff-400ab9e292da	2026-07-10	Warnings, Adverse reactions	Exact identifier ndc (package): 68462-802-60 ndc (product): 68462-802 ndc11 (package): 68462080260 rxcui: 1592742
nintedanib	NINTEDANIB	EPIC PHARMA LLC	0e12f080-fcb4-465f-b988-4fa2c79f49aa	2026-07-09	Warnings, Adverse reactions	Exact identifier ndc (package): 42806-569-60 ndc (product): 42806-569 ndc11 (package): 42806056960 rxcui: 1592742
Nintedanib Capsules, 100 mg and 150 mg	NINTEDANIB	EXELAN PHARMACEUTICALS INC.	60d8104e-cb6c-4f4f-8159-95ed57346ffa	2026-04-21	Warnings, Adverse reactions	Exact identifier ndc (package): 76282-786-60 ndc (product): 76282-786 ndc11 (package): 76282078660 rxcui: 1592742
Nintedanib	NINTEDANIB	Cipla USA Inc.	4d017c42-a823-452d-bc6f-0491dd9823e3	2026-04-02	Warnings, Adverse reactions	Exact identifier ndc (package): 69097-641-03 ndc (product): 69097-641 ndc11 (package): 69097064103 rxcui: 1592742
Nintedanib	NINTEDANIB	Apotex Corp.	b72b26c3-7731-80c0-734b-a5f53a1d89ae	2026-03-20	Warnings, Adverse reactions	Exact identifier ndc (package): 60505-4818-6 ndc (product): 60505-4818 ndc11 (package): 60505481806 rxcui: 1592742
nintedanib	NINTEDANIB	Sandoz Inc	751c3473-35d6-47d6-b405-af16a989716c	2026-01-20	Warnings, Adverse reactions	Exact identifier ndc (package): 0781-2492-60 ndc (product): 0781-2492 ndc11 (package): 00781249260 rxcui: 1592742
Nintedanib	NINTEDANIB	Dr. Reddy's Laboratories Inc.	88f8600d-0974-51ca-6f8e-28c48a379e08	2025-11-20	Warnings, Adverse reactions	Exact identifier ndc (package): 43598-148-60 ndc (product): 43598-148 ndc11 (package): 43598014860 rxcui: 1592742
Ofev	NINTEDANIB	Boehringer Ingelheim Pharmaceuticals, Inc.	da1c9f37-779e-4682-816f-93d0faa4cfc9	2025-11-20	Warnings, Adverse reactions	Exact identifier rxcui: 1592742

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 · 8 matching rows.

Set ID, RxNorm mappings, Terms table
Set ID	RxNorm mappings	Terms	SPL version	Label	Effective
da1c9f37-779e-4682-816f-93d0faa4cfc9	nintedanib 100 MG Oral Capsule [PSN] · nintedanib 100 MG Oral Capsule [SCD] · nintedanib 100 MG (as nintedanib ethanesulfonate 120.4 MG) Oral Capsule [SY]	3	21	These 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: 2014	20251120
88f8600d-0974-51ca-6f8e-28c48a379e08	nintedanib 100 MG Oral Capsule [PSN] · nintedanib 100 MG Oral Capsule [SCD] · nintedanib 100 MG (as nintedanib ethanesulfonate 120.4 MG) Oral Capsule [SY]	3	4	These highlights do not include all the information needed to use NINTEDANIB CAPSULES safely and effectively. See full prescribing information for NINTEDANIB CAPSULES. NINTEDANIB capsules, for oral use Initial U.S. Approval: 2014	20251120
4d017c42-a823-452d-bc6f-0491dd9823e3	nintedanib 100 MG Oral Capsule [PSN] · nintedanib 100 MG Oral Capsule [SCD] · nintedanib 100 MG (as nintedanib ethanesulfonate 120.4 MG) Oral Capsule [SY]	3	3	These highlights do not include all the information needed to use NINTEDANIB CAPSULES safely and effectively. See full prescribing information for NINTEDANIB CAPSULES. NINTEDANIB capsules, for oral use Initial U.S. Approval: 2014	20260402
43dae004-eaf6-4411-8c3d-db7ab2c3b41e	nintedanib 100 MG Oral Capsule [PSN] · nintedanib 100 MG Oral Capsule [SCD] · nintedanib 100 MG (as nintedanib ethanesulfonate 120.4 MG) Oral Capsule [SY]	3	2	These highlights do not include all the information needed to use NINTEDANIB CAPSULES safely and effectively. See full prescribing information for NINTEDANIB CAPSULES. NINTEDANIB CAPSULES, for oral use Initial U.S. Approval: 2014	20260415
751c3473-35d6-47d6-b405-af16a989716c	nintedanib 100 MG Oral Capsule [PSN] · nintedanib 100 MG Oral Capsule [SCD] · nintedanib 100 MG (as nintedanib ethanesulfonate 120.4 MG) Oral Capsule [SY]	3	2	These highlights do not include all the information needed to use NINTEDANIB CAPSULES safely and effectively. See full prescribing information for NINTEDANIB CAPSULES. NINTEDANIB capsules, for oral use Initial U.S. Approval: 2014	20260120
60d8104e-cb6c-4f4f-8159-95ed57346ffa	nintedanib 100 MG Oral Capsule [PSN] · nintedanib 100 MG Oral Capsule [SCD] · nintedanib 100 MG (as nintedanib ethanesulfonate 120.4 MG) Oral Capsule [SY]	3	1	These highlights do not include all the information needed to use NINTEDANIB CAPSULES safely and effectively. See full prescribing information for NINTEDANIB CAPSULES. NINTEDANIB capsules, for oral use Initial U.S. Approval: 2014	20260421
4ecf7f05-4a95-b98c-e063-6394a90ab896	nintedanib 100 MG Oral Capsule [PSN] · nintedanib 100 MG Oral Capsule [SCD] · nintedanib 100 MG (as nintedanib ethanesulfonate 120.4 MG) Oral Capsule [SY]	3	1	NINTEDANIB CAPSULES. These highlights do not include all the information needed to use NINTEDANIB CAPSULES safely and effectively. See full prescribing information for NINTEDANIB CAPSULES. NINTEDANIB CAPSULES, for oral use Initial U.S. Approval: 2014	20260406
b72b26c3-7731-80c0-734b-a5f53a1d89ae	nintedanib 100 MG Oral Capsule [PSN] · nintedanib 100 MG Oral Capsule [SCD] · nintedanib 100 MG (as nintedanib ethanesulfonate 120.4 MG) Oral Capsule [SY]	3	1	These highlights do not include all the information needed to use NINTEDANIB CAPSULES safely and effectively. See full prescribing information for NINTEDANIB CAPSULES. NINTEDANIB capsules, for oral use Initial U.S. Approval: 2014	20260320

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set ID	Title	Manufacturer	Effective
9925b305-c1fb-43b6-a5fd-e03f14f28e6c	These highlights do not include all the information needed to use NINTEDANIB CAPSULES safely and effectively. See full prescribing information for NINTEDANIB CAPSULES. NINTEDANIB capsules, for oral use Initial U.S. Approval: 2014	Macleods Pharmaceuticals Limited	20260803
4ecf7f05-4a95-b98c-e063-6394a90ab896	NINTEDANIB CAPSULES. These highlights do not include all the information needed to use NINTEDANIB CAPSULES safely and effectively. See full prescribing information for NINTEDANIB CAPSULES. NINTEDANIB CAPSULES, for oral use Initial U.S. Approval: 2014	Golden State Medical Supply, Inc.	20260730
43dae004-eaf6-4411-8c3d-db7ab2c3b41e	These highlights do not include all the information needed to use NINTEDANIB CAPSULES safely and effectively. See full prescribing information for NINTEDANIB CAPSULES. NINTEDANIB CAPSULES, for oral use Initial U.S. Approval: 2014	Edenbridge Pharmaceuticals LLC.	20260729
572722d7-338a-e4d2-e063-6394a90a257c	Nintedanib Capsule Rx only These highlights do not include all the information needed to use NINTEDANIB CAPSULES safely and effectively. See full prescribing information for NINTEDANIB CAPSULES. Initial U.S. Approval: 2014	AvKARE	20260721
43dae004-eaf6-4411-8c3d-db7ab2c3b41e	These highlights do not include all the information needed to use NINTEDANIB CAPSULES safely and effectively. See full prescribing information for NINTEDANIB CAPSULES. NINTEDANIB CAPSULES, for oral use Initial U.S. Approval: 2014	Edenbridge Pharmaceuticals LLC.	20260714
b14164fb-0276-4ad1-a5ff-400ab9e292da	These highlights do not include all the information needed to use NINTEDANIB CAPSULES safely and effectively. See full prescribing information for NINTEDANIB CAPSULES. NINTEDANIB capsules, for oral use Initial U.S. Approval: 2014	Glenmark Pharmaceuticals Inc., USA \| Cyndea Pharma SL	20260710
0e12f080-fcb4-465f-b988-4fa2c79f49aa	These highlights do not include all the information needed to use NINTEDANIB CAPSULES safely and effectively. See full prescribing information for NINTEDANIB CAPSULES. NINTEDANIB capsules, for oral use Initial U.S. Approval: 2014	EPIC PHARMA LLC	20260709
4ecf7f05-4a95-b98c-e063-6394a90ab896	NINTEDANIB CAPSULES. These highlights do not include all the information needed to use NINTEDANIB CAPSULES safely and effectively. See full prescribing information for NINTEDANIB CAPSULES. NINTEDANIB CAPSULES, for oral use Initial U.S. Approval: 2014	Golden State Medical Supply, Inc.	20260616
60d8104e-cb6c-4f4f-8159-95ed57346ffa	These highlights do not include all the information needed to use NINTEDANIB CAPSULES safely and effectively. See full prescribing information for NINTEDANIB CAPSULES. NINTEDANIB capsules, for oral use Initial U.S. Approval: 2014	EXELAN PHARMACEUTICALS INC. \| Cipla Limited \| CIPLA LIMITED VIRGONAGAR \| Douglas Manufacturing Limited	20260421
43dae004-eaf6-4411-8c3d-db7ab2c3b41e	These highlights do not include all the information needed to use NINTEDANIB CAPSULES safely and effectively. See full prescribing information for NINTEDANIB CAPSULES. NINTEDANIB CAPSULES, for oral use Initial U.S. Approval: 2014	Edenbridge Pharmaceuticals LLC.	20260415
4ecf7f05-4a95-b98c-e063-6394a90ab896	NINTEDANIB CAPSULES. These highlights do not include all the information needed to use NINTEDANIB CAPSULES safely and effectively. See full prescribing information for NINTEDANIB CAPSULES. NINTEDANIB CAPSULES, for oral use Initial U.S. Approval: 2014	Golden State Medical Supply, Inc.	20260406
4d017c42-a823-452d-bc6f-0491dd9823e3	These highlights do not include all the information needed to use NINTEDANIB CAPSULES safely and effectively. See full prescribing information for NINTEDANIB CAPSULES. NINTEDANIB capsules, for oral use Initial U.S. Approval: 2014	Cipla USA Inc. \| Cipla Limited \| CIPLA LIMITED GOA \| CIPLA LIMITED VIRGONAGAR \| CIPLA LIMITED KURKUMBH	20260402
b72b26c3-7731-80c0-734b-a5f53a1d89ae	These highlights do not include all the information needed to use NINTEDANIB CAPSULES safely and effectively. See full prescribing information for NINTEDANIB CAPSULES. NINTEDANIB capsules, for oral use Initial U.S. Approval: 2014	Apotex Corp.	20260320
751c3473-35d6-47d6-b405-af16a989716c	These highlights do not include all the information needed to use NINTEDANIB CAPSULES safely and effectively. See full prescribing information for NINTEDANIB CAPSULES. NINTEDANIB capsules, for oral use Initial U.S. Approval: 2014	Sandoz Inc	20260120
88f8600d-0974-51ca-6f8e-28c48a379e08	These highlights do not include all the information needed to use NINTEDANIB CAPSULES safely and effectively. See full prescribing information for NINTEDANIB CAPSULES. NINTEDANIB capsules, for oral use Initial U.S. Approval: 2014	Dr. Reddy's Laboratories Inc. \| Dr. Reddy's Laboratories Limited, FTO-SEZ - Process Unit-02	20251120

Drug Classes#

Source, Class ID, Class table
Source	Class ID	Class	Type	Relationship	Drug concept
ATC	L01EX	Other protein kinase inhibitors	ATC1-4		nintedanib
FDASPL	N0000175605	Kinase Inhibitor	EPC	has_epc	nintedanib
FDASPL	N0000175076	Protein Kinase Inhibitors	MOA	has_moa	nintedanib
MEDRT	D007211	Indoles	CHEM	has_ingredient	nintedanib
MEDRT	D054990	Idiopathic Pulmonary Fibrosis	DISEASE	may_treat	nintedanib
MEDRT	N0000020000	Receptor Tyrosine Kinase Inhibitors	MOA	has_moa	nintedanib
MEDRT	N0000175678	Decreased Endothelial Proliferation	PE	has_pe	nintedanib

Group, Type, Concept table
Group	Type	Concept	Source
BN	BN	Ofev	rxnav_allrelated
DF	DF	Oral Capsule	rxnav_allrelated
DFG	DFG	Oral Product	rxnav_allrelated
DFG	DFG	Pill	rxnav_allrelated
IN	IN	nintedanib	rxnav_allrelated
SBD	SBD	nintedanib 100 MG Oral Capsule [Ofev]	rxnav_allrelated
SBDC	SBDC	nintedanib 100 MG [Ofev]	rxnav_allrelated
SBDF	SBDF	nintedanib Oral Capsule [Ofev]	rxnav_allrelated
SBDG	SBDG	Ofev Oral Product	rxnav_allrelated
SBDG	SBDG	Ofev Pill	rxnav_allrelated
SCD	SCD	nintedanib 100 MG Oral Capsule	rxnav_allrelated
SCDC	SCDC	nintedanib 100 MG	rxnav_allrelated
SCDF	SCDF	nintedanib Oral Capsule	rxnav_allrelated
SCDG	SCDG	nintedanib Oral Product	rxnav_allrelated
SCDG	SCDG	nintedanib Pill	rxnav_allrelated

Properties#

Category, Property, Value table
Category	Property	Value
ATTRIBUTES	AVAILABLE_STRENGTH	100 MG
ATTRIBUTES	GENERAL_CARDINALITY	SINGLE
ATTRIBUTES	HUMAN_DRUG	US
ATTRIBUTES	RXNAV_HUMAN_DRUG	US
ATTRIBUTES	SCHEDULE	0
CODES	ANDA	ANDA212555
CODES	ANDA	ANDA212609
CODES	ANDA	ANDA216915
CODES	ANDA	ANDA218472
CODES	ANDA	ANDA219227
CODES	ANDA	ANDA219283
CODES	ANDA	ANDA219819
CODES	ANDA	ANDA219926
CODES	SNOMEDCT	865888008
CODES	VUID	4033817
NAMES	Prescribable Synonym	nintedanib 100 MG Oral Capsule
SOURCES	Source	Gold Standard Alchemy
SOURCES	Source	Metathesaurus FDA Structured Product Labels
SOURCES	Source	Micromedex RED BOOK
SOURCES	Source	Multum MediSource Lexicon
SOURCES	Source	National Drug Data File Plus Source Vocabulary
SOURCES	Source	US Edition of SNOMED_CT
SOURCES	Source	Veterans Health Administration National Drug File