FDA.reportPublic FDA data

nintedanib

Product NDC
73190-097
Requested package NDC
73190-097-60
11-digit product format
731900097
Labeler code
73190
Product ID
73190-097_572722d7-338b-e4d2-e063-6394a90a257c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nintedanib
Dosage form
CAPSULE
Route
ORAL
Labeler
AvKARE
Application
ANDA212555
Marketing category
ANDA
Marketing start
2026-07-21
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 43.

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
A212555-001NINTEDANIB ESYLATENINTEDANIB ESYLATEEQ 100MG BASECAPSULE / ORALAB2026-07-09
A212555-002NINTEDANIB ESYLATENINTEDANIB ESYLATEEQ 150MG BASECAPSULE / ORALAB2026-07-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A212555-001AB
A212555-002AB

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
2026-09-14 22:38:342026-08A212555-001NINTEDANIB ESYLATEEQ 100MG BASECAPSULE / ORALAB2026-07-0984e616aacf4f…
2026-09-14 22:38:342026-08A212555-002NINTEDANIB ESYLATEEQ 150MG BASECAPSULE / ORALAB2026-07-0984e616aacf4f…
2026-08-18 06:07:402026-07A212555-001NINTEDANIB ESYLATEEQ 100MG BASECAPSULE / ORALAB2026-07-09caaa826d4ba7…
2026-08-18 06:07:402026-07A212555-002NINTEDANIB ESYLATEEQ 150MG BASECAPSULE / ORALAB2026-07-09caaa826d4ba7…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A212555-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A212555-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A212555-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A212555-002AB1caaa826d4ba7…

Reported adverse events (FAERS/openFDA)#

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

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
572722d7-338a-e4d2-e063-6394a90a257cAvailable on FDA.report

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
nintedanibNINTEDANIBAvKARE572722d7-338a-e4d2-e063-6394a90a257c2026-07-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212555
application number: ANDA212555
ndc (package): 73190-097-60
ndc (product): 73190-097
ndc11 (package): 73190009760
nintedanibNINTEDANIBGlenmark Pharmaceuticals Inc., USAb14164fb-0276-4ad1-a5ff-400ab9e292da2026-07-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212555
application number: ANDA212555

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
73190-097-607319000976060 CAPSULE in 1 BOTTLE (73190-097-60) 60 capsule2026-07-21NoNoCurrent