Home NDC 0078-0592 Tasigna
Product NDC 0078-0592
11-digit product format 000780592
Labeler code 0078
Product ID 0078-0592_fe0fef5b-4f09-4f67-946f-67e84d10e102
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name nilotinib
Dosage form CAPSULE
Route ORAL
Labeler Novartis Pharmaceuticals Corporation
Application NDA022068
Marketing category NDA
Marketing start 2007-10-29
Substance NILOTINIB HYDROCHLORIDE MONOHYDRATE
Active strength 150 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 N022068-001 TASIGNA NILOTINIB HYDROCHLORIDE EQ 200MG BASE CAPSULE / ORAL AB RLD, RS 2007-10-29 N022068-002 TASIGNA NILOTINIB HYDROCHLORIDE EQ 150MG BASE CAPSULE / ORAL AB RLD 2010-06-17 N022068-003 TASIGNA NILOTINIB HYDROCHLORIDE EQ 50MG BASE CAPSULE / ORAL AB RLD 2018-03-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 42 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022068-001 8389537 2026-07-18 U-1374 2013-03-29 N022068-001 8415363 2026-07-18 U-1374 Drug substance, Drug product 2013-06-13 N022068-001 8415363 2026-07-18 U-1407 Drug substance, Drug product 2013-06-13 N022068-001 8501760 2026-07-18 Drug product 2013-08-09 N022068-001 8389537*PED 2027-01-18 Pediatric extension N022068-001 8415363*PED 2027-01-18 Pediatric extension N022068-001 8501760*PED 2027-01-18 Pediatric extension N022068-001 8293756 2027-09-25 Drug product 2014-10-08 N022068-001 8293756*PED 2028-03-25 Pediatric extension N022068-001 8163904 2028-08-23 Drug substance, Drug product 2012-05-10 N022068-001 8163904*PED 2029-02-23 Pediatric extension N022068-001 9061029 2032-04-07 U-1374 Drug substance 2016-12-01 N022068-001 9061029 2032-04-07 U-3231 Drug substance 2016-12-01 N022068-001 9061029*PED 2032-10-07 Pediatric extension N022068-002 8389537 2026-07-18 U-1374 N022068-002 8415363 2026-07-18 U-1374 Drug substance, Drug product N022068-002 8415363 2026-07-18 U-1407 Drug substance, Drug product N022068-002 8501760 2026-07-18 Drug product 2013-08-09 N022068-002 8389537*PED 2027-01-18 Pediatric extension N022068-002 8415363*PED 2027-01-18 Pediatric extension N022068-002 8501760*PED 2027-01-18 Pediatric extension N022068-002 8293756 2027-09-25 Drug product 2014-10-08 N022068-002 8293756*PED 2028-03-25 Pediatric extension N022068-002 8163904 2028-08-23 Drug substance, Drug product N022068-002 8163904*PED 2029-02-23 Pediatric extension N022068-002 9061029 2032-04-07 U-1374 Drug substance 2016-12-01 N022068-002 9061029 2032-04-07 U-3231 Drug substance 2016-12-01 N022068-002 9061029*PED 2032-10-07 Pediatric extension N022068-003 8389537 2026-07-18 U-1374 2018-04-12 N022068-003 8415363 2026-07-18 U-1374 Drug substance, Drug product 2018-04-12 N022068-003 8415363 2026-07-18 U-1407 Drug substance, Drug product 2018-04-12 N022068-003 8501760 2026-07-18 Drug product 2018-04-12 N022068-003 8389537*PED 2027-01-18 Pediatric extension N022068-003 8415363*PED 2027-01-18 Pediatric extension N022068-003 8501760*PED 2027-01-18 Pediatric extension N022068-003 8293756 2027-09-25 Drug product 2018-04-12 N022068-003 8293756*PED 2028-03-25 Pediatric extension N022068-003 8163904 2028-08-23 Drug substance, Drug product 2018-04-12 N022068-003 8163904*PED 2029-02-23 Pediatric extension N022068-003 9061029 2032-04-07 U-1374 Drug substance 2018-04-12 N022068-003 9061029 2032-04-07 U-3231 Drug substance 2018-04-12 N022068-003 9061029*PED 2032-10-07 Pediatric extension
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 6 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 N022068-001 TASIGNA EQ 200MG BASE CAPSULE / ORAL AB RLD, RS 2007-10-29 a50c72e98297…2026-08-01 22:54:32 2026-06 N022068-002 TASIGNA EQ 150MG BASE CAPSULE / ORAL AB RLD 2010-06-17 a50c72e98297…2026-08-01 22:54:32 2026-06 N022068-003 TASIGNA EQ 50MG BASE CAPSULE / ORAL AB RLD 2018-03-22 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 2 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-01 22:54:32 2026-06 N022068-001 8389537 2026-07-18 U-1374 2013-03-29 a50c72e98297…2026-08-01 22:54:32 2026-06 N022068-001 8415363 2026-07-18 U-1407 Drug substance, Drug product 2013-06-13 a50c72e98297…2026-08-01 22:54:32 2026-06 N022068-001 8415363 2026-07-18 U-1374 Drug substance, Drug product 2013-06-13 a50c72e98297…2026-08-01 22:54:32 2026-06 N022068-001 8501760 2026-07-18 Drug product 2013-08-09 a50c72e98297…2026-08-01 22:54:32 2026-06 N022068-001 8389537*PED 2027-01-18 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N022068-001 8415363*PED 2027-01-18 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N022068-001 8501760*PED 2027-01-18 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N022068-001 8293756 2027-09-25 Drug product 2014-10-08 a50c72e98297…2026-08-01 22:54:32 2026-06 N022068-001 8293756*PED 2028-03-25 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N022068-001 8163904 2028-08-23 Drug substance, Drug product 2012-05-10 a50c72e98297…2026-08-01 22:54:32 2026-06 N022068-001 8163904*PED 2029-02-23 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N022068-001 9061029 2032-04-07 U-1374 Drug substance 2016-12-01 a50c72e98297…2026-08-01 22:54:32 2026-06 N022068-001 9061029 2032-04-07 U-3231 Drug substance 2016-12-01 a50c72e98297…2026-08-01 22:54:32 2026-06 N022068-001 9061029*PED 2032-10-07 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N022068-002 8389537 2026-07-18 U-1374 a50c72e98297…2026-08-01 22:54:32 2026-06 N022068-002 8415363 2026-07-18 U-1407 Drug substance, Drug product a50c72e98297…2026-08-01 22:54:32 2026-06 N022068-002 8415363 2026-07-18 U-1374 Drug substance, Drug product a50c72e98297…2026-08-01 22:54:32 2026-06 N022068-002 8501760 2026-07-18 Drug product 2013-08-09 a50c72e98297…2026-08-01 22:54:32 2026-06 N022068-002 8389537*PED 2027-01-18 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N022068-002 8415363*PED 2027-01-18 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N022068-002 8501760*PED 2027-01-18 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N022068-002 8293756 2027-09-25 Drug product 2014-10-08 a50c72e98297…2026-08-01 22:54:32 2026-06 N022068-002 8293756*PED 2028-03-25 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N022068-002 8163904 2028-08-23 Drug substance, Drug product a50c72e98297…2026-08-01 22:54:32 2026-06 N022068-002 8163904*PED 2029-02-23 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N022068-002 9061029 2032-04-07 U-1374 Drug substance 2016-12-01 a50c72e98297…2026-08-01 22:54:32 2026-06 N022068-002 9061029 2032-04-07 U-3231 Drug substance 2016-12-01 a50c72e98297…2026-08-01 22:54:32 2026-06 N022068-002 9061029*PED 2032-10-07 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N022068-003 8389537 2026-07-18 U-1374 2018-04-12 a50c72e98297…2026-08-01 22:54:32 2026-06 N022068-003 8415363 2026-07-18 U-1407 Drug substance, Drug product 2018-04-12 a50c72e98297…2026-08-01 22:54:32 2026-06 N022068-003 8415363 2026-07-18 U-1374 Drug substance, Drug product 2018-04-12 a50c72e98297…2026-08-01 22:54:32 2026-06 N022068-003 8501760 2026-07-18 Drug product 2018-04-12 a50c72e98297…2026-08-01 22:54:32 2026-06 N022068-003 8389537*PED 2027-01-18 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N022068-003 8415363*PED 2027-01-18 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N022068-003 8501760*PED 2027-01-18 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N022068-003 8293756 2027-09-25 Drug product 2018-04-12 a50c72e98297…2026-08-01 22:54:32 2026-06 N022068-003 8293756*PED 2028-03-25 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N022068-003 8163904 2028-08-23 Drug substance, Drug product 2018-04-12 a50c72e98297…2026-08-01 22:54:32 2026-06 N022068-003 8163904*PED 2029-02-23 Pediatric extension a50c72e98297…2026-08-01 22:54:32 2026-06 N022068-003 9061029 2032-04-07 U-1374 Drug substance 2018-04-12 a50c72e98297…
Observed Orange Book exclusivity history# 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Tasigna NILOTINIB Novartis Pharmaceuticals Corporation 6093952a-5248-45cb-ad17-33716a411146 2025-12-16 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 022068 application number: NDA022068 ndc (product): 0078-0592
Additional Listing Data#
Finished product Yes
Brand name base Tasigna
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NILOTINIB HYDROCHLORIDE MONOHYDRATE 150 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 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 746606 Internal RxNorm lookup 746609 Internal RxNorm lookup 997653 Internal RxNorm lookup 1002300 Internal RxNorm lookup 2002717 Internal RxNorm lookup 2002719 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 0078-0592-51 Tasigna 28 in 1 BLISTER PACK CAPSULE 28 42 0078-0592-87 Tasigna 28 in 1 BLISTER PACK CAPSULE 28 42 0078-0592-87 Tasigna 4 in 1 CARTON CAPSULE 4 42
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0078-0592 TASIGNA (NILOTINIB) CAPSULE [NOVARTIS PHARMACEUTICALS CORPORATION] 41 Current NDC, Legacy NDC, 3 package rows 20250223_6093952a-5248-45cb-ad17-33716a411146.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0078-0592-51 00078059251 28 CAPSULE in 1 BLISTER PACK (0078-0592-51) 28 capsule 2007-10-29 0000-00-00 No No Current 0078-0592-87 00078059287 4 BLISTER PACK in 1 CARTON (0078-0592-87) / 28 CAPSULE in 1 BLISTER PACK 4 blister pack 2007-10-29 0000-00-00 No No Current