FDA.reportPublic FDA data

Nintedanib

Product NDC
51407-985
11-digit product format
514070985
Labeler code
51407
Product ID
51407-985_4ecf4931-38dc-5a86-e063-6394a90afe25
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nintedanib
Dosage form
CAPSULE
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA219819
Marketing category
ANDA
Marketing start
2026-02-15
Substance
NINTEDANIB ESYLATE
Active strength
150 mg/1
Pharmacologic classes
Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A219819-001NINTEDANIB ESYLATENINTEDANIB ESYLATEEQ 100MG BASECAPSULE / ORALAB2026-04-02
A219819-002NINTEDANIB ESYLATENINTEDANIB ESYLATEEQ 150MG BASECAPSULE / ORALAB2026-04-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A219819-001AB
A219819-002AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A219819-001NINTEDANIB ESYLATEEQ 100MG BASECAPSULE / ORALAB2026-04-02a50c72e98297…
2026-08-01 22:54:322026-06A219819-002NINTEDANIB ESYLATEEQ 150MG BASECAPSULE / ORALAB2026-04-02a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A219819-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A219819-002AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NintedanibNINTEDANIBEdenbridge Pharmaceuticals LLC.43dae004-eaf6-4411-8c3d-db7ab2c3b41e2026-07-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219819
application number: ANDA219819
NintedanibNINTEDANIBGolden State Medical Supply, Inc.4ecf7f05-4a95-b98c-e063-6394a90ab8962026-06-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219819
application number: ANDA219819
ndc (product): 51407-985

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NINTEDANIB ESYLATE150 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
42F62RTZ4GInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1592742Internal RxNorm lookup
1592750Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4ecf7f05-4a95-b98c-e063-6394a90ab896Available on FDA.report

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
51407-985-60Nintedanib60 in 1 BOTTLECAPSULE601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-985-60EA - Each51407-9852415e0f0-3d5c-4499-99ca-986aaf21d37d12026-05-22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
51407-985-605140709856060 CAPSULE in 1 BOTTLE (51407-985-60) 60 capsule2026-02-15NoNoCurrent