Home NDC 60505-3803-7 Nilotinib
Product NDC 60505-3803
Requested package NDC 60505-3803-7
11-digit product format 605053803
Labeler code 60505
Product ID 60505-3803_6c941626-eccb-8cc5-eea9-cf3bc4ee3f0e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name nilotinib
Dosage form CAPSULE
Route ORAL
Labeler Apotex Corp.
Application ANDA203640
Marketing category ANDA
Marketing start 2025-05-23
Substance NILOTINIB
Active strength 50 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 1 .
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 A203640-001 NILOTINIB HYDROCHLORIDE NILOTINIB HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 2024-01-05 A203640-002 NILOTINIB HYDROCHLORIDE NILOTINIB HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2024-01-05 A203640-003 NILOTINIB HYDROCHLORIDE NILOTINIB HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL AB 2024-01-05
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.
Product history page 1 of 2 · 51 observed 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 2026-02-19 14:30 UTC 2026-02 A203640-001 NILOTINIB HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 2024-01-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203640-002 NILOTINIB HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2024-01-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203640-003 NILOTINIB HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL AB 2024-01-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203640-001 NILOTINIB HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 2024-01-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203640-002 NILOTINIB HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2024-01-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203640-003 NILOTINIB HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL AB 2024-01-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203640-001 NILOTINIB HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB 2024-01-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203640-002 NILOTINIB HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB 2024-01-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203640-003 NILOTINIB HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL AB 2024-01-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203640-001 NILOTINIB HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL 2024-01-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203640-002 NILOTINIB HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL 2024-01-05 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203640-003 NILOTINIB HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL 2024-01-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203640-001 NILOTINIB HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL 2024-01-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203640-002 NILOTINIB HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL 2024-01-05 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203640-003 NILOTINIB HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL 2024-01-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203640-001 NILOTINIB HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL 2024-01-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203640-002 NILOTINIB HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL 2024-01-05 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203640-003 NILOTINIB HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL 2024-01-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203640-001 NILOTINIB HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL 2024-01-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203640-002 NILOTINIB HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL 2024-01-05 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203640-003 NILOTINIB HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL 2024-01-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203640-001 NILOTINIB HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL 2024-01-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203640-002 NILOTINIB HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL 2024-01-05 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203640-003 NILOTINIB HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL 2024-01-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203640-001 NILOTINIB HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL 2024-01-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203640-002 NILOTINIB HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL 2024-01-05 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203640-003 NILOTINIB HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL 2024-01-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203640-001 NILOTINIB HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL 2024-01-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203640-002 NILOTINIB HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL 2024-01-05 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203640-003 NILOTINIB HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL 2024-01-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203640-001 NILOTINIB HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL 2024-01-05 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203640-002 NILOTINIB HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL 2024-01-05 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203640-003 NILOTINIB HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL 2024-01-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203640-001 NILOTINIB HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL 2024-01-05 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203640-002 NILOTINIB HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL 2024-01-05 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203640-003 NILOTINIB HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL 2024-01-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203640-001 NILOTINIB HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL 2024-01-05 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203640-002 NILOTINIB HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL 2024-01-05 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203640-003 NILOTINIB HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL 2024-01-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203640-001 NILOTINIB HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL 2024-01-05 8072bd15b7f6…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203640-001 PC 2025-11-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203640-002 PC 2025-11-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203640-003 PC 2025-11-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203640-001 PC 2025-11-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203640-002 PC 2025-11-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203640-003 PC 2025-11-19 6a471c1ec25d…
Additional Listing Data#
Finished product Yes
Brand name base Nilotinib
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NILOTINIB 50 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination F41401512X 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 60505-3803-7 Nilotinib 120 in 1 BOTTLE CAPSULE 120 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60505-3803 NILOTINIB CAPSULE [APOTEX CORP.] 4 Current NDC, 1 package rows 20250525_8283672c-619f-fe60-3d25-040f95ac1440.zip
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 60505-3803-7 60505380307 120 CAPSULE in 1 BOTTLE (60505-3803-7) 120 capsule 2025-05-23 No No Current