FDA.reportPublic FDA data

Nintedanib

Product NDC
69097-639
11-digit product format
690970639
Labeler code
69097
Product ID
69097-639_128511d3-f076-4a68-993b-53ad52233ee2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nintedanib
Dosage form
CAPSULE
Route
ORAL
Labeler
Cipla USA Inc.
Application
ANDA212609
Marketing category
ANDA
Marketing start
2026-04-02
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
A212609-001NINTEDANIB ESYLATENINTEDANIB ESYLATEEQ 100MG BASECAPSULE / ORALAB2026-04-02
A212609-002NINTEDANIB 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
A212609-001AB
A212609-002AB

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 22:54:322026-06A212609-001NINTEDANIB ESYLATEEQ 100MG BASECAPSULE / ORALAB2026-04-02a50c72e98297…
2026-08-01 22:54:322026-06A212609-002NINTEDANIB 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 22:54:322026-06A212609-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A212609-002AB1a50c72e98297…

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
Nintedanib Capsules, 100 mg and 150 mgNINTEDANIBEXELAN PHARMACEUTICALS INC.60d8104e-cb6c-4f4f-8159-95ed57346ffa2026-04-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212609
application number: ANDA212609
NintedanibNINTEDANIBCipla USA Inc.4d017c42-a823-452d-bc6f-0491dd9823e32026-04-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212609
application number: ANDA212609
ndc (product): 69097-639

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
4d017c42-a823-452d-bc6f-0491dd9823e3Available 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
69097-639-03Nintedanib60 in 1 BOTTLECAPSULE603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-639-03EA - Each69097-639237a231e-0e81-4e6a-81a3-9467b1b7c0f312026-04-20

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1592742nintedanib 100 MG Oral CapsulePSN4d017c42-a823-452d-bc6f-0491dd9823e33
1592750nintedanib 150 MG Oral CapsulePSN4d017c42-a823-452d-bc6f-0491dd9823e33
1592742nintedanib 100 MG Oral CapsuleSCD4d017c42-a823-452d-bc6f-0491dd9823e33
1592750nintedanib 150 MG Oral CapsuleSCD4d017c42-a823-452d-bc6f-0491dd9823e33
1592742nintedanib 100 MG (as nintedanib ethanesulfonate 120.4 MG) Oral CapsuleSY4d017c42-a823-452d-bc6f-0491dd9823e33
1592750nintedanib 150 MG (as nintedanib ethanesulfonate 180.6 MG) Oral CapsuleSY4d017c42-a823-452d-bc6f-0491dd9823e33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69097-639-036909706390360 CAPSULE in 1 BOTTLE (69097-639-03) 60 capsule2026-04-02NoNoCurrent