tasigna

Generic: nilotinib

Labeler: novartis pharmaceuticals corporation
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name tasigna
Generic Name nilotinib
Labeler novartis pharmaceuticals corporation
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

nilotinib hydrochloride monohydrate 200 mg/1

Manufacturer
Novartis Pharmaceuticals Corporation

Identifiers & Regulatory

Product NDC 0078-0526
Product ID 0078-0526_fe0fef5b-4f09-4f67-946f-67e84d10e102
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022068
Listing Expiration 2026-12-31
Marketing Start 2007-10-29

Pharmacologic Class

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]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00780526
Hyphenated Format 0078-0526

Supplemental Identifiers

RxCUI
746606 746609 997653 1002300 2002717 2002719
UNII
5JHU0N1R6K

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name tasigna (source: ndc)
Generic Name nilotinib (source: ndc)
Application Number NDA022068 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 28 CAPSULE in 1 BLISTER PACK (0078-0526-51)
  • 4 BLISTER PACK in 1 CARTON (0078-0526-87) / 28 CAPSULE in 1 BLISTER PACK
source: ndc

Packages (2)

0078-0526-51 28 CAPSULE in 1 BLISTER PACK (0078-0526-51) 0078-0526-87 4 BLISTER PACK in 1 CARTON (0078-0526-87) / 28 CAPSULE in 1 BLISTER PACK

Ingredients (1)

nilotinib hydrochloride monohydrate (200 mg/1)

Linked Drug Pages (1)

Tasigna ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "fe0fef5b-4f09-4f67-946f-67e84d10e102", "openfda": {"unii": ["5JHU0N1R6K"], "rxcui": ["746606", "746609", "997653", "1002300", "2002717", "2002719"], "spl_set_id": ["6093952a-5248-45cb-ad17-33716a411146"], "manufacturer_name": ["Novartis Pharmaceuticals Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "28 CAPSULE in 1 BLISTER PACK (0078-0526-51)", "package_ndc": "0078-0526-51", "marketing_start_date": "20071029"}, {"sample": false, "description": "4 BLISTER PACK in 1 CARTON (0078-0526-87)  / 28 CAPSULE in 1 BLISTER PACK", "package_ndc": "0078-0526-87", "marketing_start_date": "20071029"}], "brand_name": "Tasigna", "product_id": "0078-0526_fe0fef5b-4f09-4f67-946f-67e84d10e102", "dosage_form": "CAPSULE", "pharm_class": ["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]"], "product_ndc": "0078-0526", "generic_name": "nilotinib", "labeler_name": "Novartis Pharmaceuticals Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tasigna", "active_ingredients": [{"name": "NILOTINIB HYDROCHLORIDE MONOHYDRATE", "strength": "200 mg/1"}], "application_number": "NDA022068", "marketing_category": "NDA", "marketing_start_date": "20071029", "listing_expiration_date": "20261231"}