Home NDC 43598-456 Nilotinib
Product NDC 43598-456
11-digit product format 435980456
Labeler code 43598
Product ID 43598-456_0e4d3a09-2813-d066-3d1b-2a7e0b196fd5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nilotinib
Dosage form CAPSULE
Route ORAL
Labeler Dr. Reddy's Laboratories Inc
Application ANDA218350
Marketing category ANDA
Marketing start 2025-11-19
Substance NILOTINIB HYDROCHLORIDE MONOHYDRATE
Active strength 200 mg/1
Pharmacologic classes Bcr-Abl Tyrosine Kinase Inhibitors [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Kinase Inhibitor [EPC], P-Glycoprotein Inhibitors [MoA], UGT1A1 Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A218350-001 NILOTINIB HYDROCHLORIDE NILOTINIB HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 2025-11-19 A218350-002 NILOTINIB HYDROCHLORIDE NILOTINIB HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2025-11-19 A218350-003 NILOTINIB HYDROCHLORIDE NILOTINIB HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL AB 2025-11-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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 2026-08-18 06:07:40 2026-07 A218350-001 NILOTINIB HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 2025-11-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218350-002 NILOTINIB HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2025-11-19 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218350-003 NILOTINIB HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL AB 2025-11-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A218350-001 NILOTINIB HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 2025-11-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218350-002 NILOTINIB HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2025-11-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218350-003 NILOTINIB HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL AB 2025-11-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218350-001 NILOTINIB HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 2025-11-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218350-002 NILOTINIB HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2025-11-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218350-003 NILOTINIB HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL AB 2025-11-19 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218350-001 NILOTINIB HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 2025-11-19 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218350-002 NILOTINIB HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2025-11-19 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218350-003 NILOTINIB HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL AB 2025-11-19 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Nilotinib
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NILOTINIB HYDROCHLORIDE MONOHYDRATE 200 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5JHU0N1R6K Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 746606 Internal RxNorm lookup 997653 Internal RxNorm lookup 2002717 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 43598-456-46 Nilotinib 8 in 1 CARTON CAPSULE 8 9 43598-456-74 Nilotinib 14 in 1 BLISTER PACK CAPSULE 14 9
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 43598-456-46 43598045646 8 BLISTER PACK in 1 CARTON (43598-456-46) / 14 CAPSULE in 1 BLISTER PACK (43598-456-74) 8 blister pack 2025-11-19 No No Current 43598-456-74 43598045674 14 in 1 BLISTER PACK Historical