Home NDC 33342-550 Nintedanib esylate
Product NDC 33342-550
11-digit product format 333420550
Labeler code 33342
Product ID 33342-550_9925b305-c1fb-43b6-a5fd-e03f14f28e6c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nintedanib esylate
Dosage form CAPSULE
Route ORAL
Labeler Macleods Pharmaceuticals Limited
Application ANDA219926
Marketing category ANDA
Marketing start 2026-08-03
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 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A219926-001 NINTEDANIB ESYLATE NINTEDANIB ESYLATE EQ 100MG BASE CAPSULE / ORAL AB 2026-08-03 A219926-002 NINTEDANIB ESYLATE NINTEDANIB ESYLATE EQ 150MG BASE CAPSULE / ORAL AB 2026-08-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A219926-001 NINTEDANIB ESYLATE EQ 100MG BASE CAPSULE / ORAL AB 2026-08-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 A219926-002 NINTEDANIB ESYLATE EQ 150MG BASE CAPSULE / ORAL AB 2026-08-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 A219926-001 NINTEDANIB ESYLATE EQ 100MG BASE CAPSULE / ORAL AB 2026-08-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A219926-002 NINTEDANIB ESYLATE EQ 150MG BASE CAPSULE / ORAL AB 2026-08-03 caaa826d4ba7…
Observed Orange Book normalized TE history# 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 esylate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NINTEDANIB ESYLATE 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 42F62RTZ4G Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1592742 Internal RxNorm lookup 1592750 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 33342-550-09 33342055009 60 CAPSULE in 1 BOTTLE (33342-550-09) 60 capsule 2026-08-03 No No Current