FDA.reportPublic FDA data

Nintedanib

Product NDC
42799-972
11-digit product format
427990972
Labeler code
42799
Product ID
42799-972_48de753a-023e-4074-bad4-f406bc347015
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nintedanib
Dosage form
CAPSULE
Route
ORAL
Labeler
Edenbridge Pharmaceuticals LLC.
Application
ANDA219819
Marketing category
ANDA
Marketing start
2026-04-03
Substance
NINTEDANIB ESYLATE
Active strength
100 mg/1
Pharmacologic classes
Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Nintedanib
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NINTEDANIB ESYLATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii42F62RTZ4G
Rxcui1592742, 1592750

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1fc30a7e-89c2-469f-9732-0fc1f1d22141Product name120141124

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42799-972-01Nintedanib60 in 1 BOTTLECAPSULE602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42799-972-01EA - Each42799-9722741b416-c868-4514-b514-37a7678a17d512026-05-22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1592742nintedanib 100 MG Oral CapsulePSN43dae004-eaf6-4411-8c3d-db7ab2c3b41e2
1592750nintedanib 150 MG Oral CapsulePSN43dae004-eaf6-4411-8c3d-db7ab2c3b41e2
1592742nintedanib 100 MG Oral CapsuleSCD43dae004-eaf6-4411-8c3d-db7ab2c3b41e2
1592750nintedanib 150 MG Oral CapsuleSCD43dae004-eaf6-4411-8c3d-db7ab2c3b41e2
1592742nintedanib 100 MG (as nintedanib ethanesulfonate 120.4 MG) Oral CapsuleSY43dae004-eaf6-4411-8c3d-db7ab2c3b41e2
1592750nintedanib 150 MG (as nintedanib ethanesulfonate 180.6 MG) Oral CapsuleSY43dae004-eaf6-4411-8c3d-db7ab2c3b41e2
1592742nintedanib 100 MG Oral CapsulePSN4ecf7f05-4a95-b98c-e063-6394a90ab8961
1592750nintedanib 150 MG Oral CapsulePSN4ecf7f05-4a95-b98c-e063-6394a90ab8961
1592742nintedanib 100 MG Oral CapsuleSCD4ecf7f05-4a95-b98c-e063-6394a90ab8961
1592750nintedanib 150 MG Oral CapsuleSCD4ecf7f05-4a95-b98c-e063-6394a90ab8961
1592742nintedanib 100 MG (as nintedanib ethanesulfonate 120.4 MG) Oral CapsuleSY4ecf7f05-4a95-b98c-e063-6394a90ab8961
1592750nintedanib 150 MG (as nintedanib ethanesulfonate 180.6 MG) Oral CapsuleSY4ecf7f05-4a95-b98c-e063-6394a90ab8961

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42799-972-014279909720160 CAPSULE in 1 BOTTLE (42799-972-01) 60 capsule2026-04-03NoNoHistorical