Home NDC 43598-148 Nintedanib
Product NDC 43598-148
11-digit product format 435980148
Labeler code 43598
Product ID 43598-148_1821bfd8-a3e9-b32c-319a-63d350543631
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nintedanib
Dosage form CAPSULE
Route ORAL
Labeler Dr. Reddy's Laboratories Inc.
Application ANDA219283
Marketing category ANDA
Marketing start 2026-04-02
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 1 .
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 A219283-001 NINTEDANIB ESYLATE NINTEDANIB ESYLATE EQ 100MG BASE CAPSULE / ORAL AB 2026-04-02 A219283-002 NINTEDANIB ESYLATE NINTEDANIB ESYLATE EQ 150MG BASE CAPSULE / ORAL AB 2026-04-02
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 2026-08-01 22:54:32 2026-06 A219283-001 NINTEDANIB ESYLATE EQ 100MG BASE CAPSULE / ORAL AB 2026-04-02 a50c72e98297…2026-08-01 22:54:32 2026-06 A219283-002 NINTEDANIB ESYLATE EQ 150MG BASE CAPSULE / ORAL AB 2026-04-02 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A219283-001 AB 1 a50c72e98297…2026-08-01 22:54:32 2026-06 A219283-002 AB 1 a50c72e98297…
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 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Nintedanib
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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 43598-148-60 Nintedanib 60 in 1 BOTTLE CAPSULE 60 4
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 43598-148-60 43598014860 60 CAPSULE in 1 BOTTLE (43598-148-60) 60 capsule 2026-04-02 No No Current