danziten

Generic: nilotinib

Labeler: azurity pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name danziten
Generic Name nilotinib
Labeler azurity pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

nilotinib 95 mg/1

Manufacturer
Azurity Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 24338-155
Product ID 24338-155_62029a35-74af-47bc-9b7b-93dcaddfd278
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA219293
Listing Expiration 2026-12-31
Marketing Start 2024-11-30

Pharmacologic Class

Established (EPC)
kinase inhibitor [epc]
Mechanism of Action
bcr-abl tyrosine kinase inhibitors [moa] cytochrome p450 2c8 inhibitors [moa] cytochrome p450 2d6 inhibitors [moa] cytochrome p450 2b6 inducers [moa] cytochrome p450 2c8 inducers [moa] ugt1a1 inhibitors [moa] p-glycoprotein inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 24338155
Hyphenated Format 24338-155

Supplemental Identifiers

RxCUI
2698564 2698570 2698572 2698574
UNII
F41401512X
NUI
N0000175605 N0000020009 N0000187062 N0000182137 N0000187064 N0000187063 N0000191272 N0000185503

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 danziten (source: ndc)
Generic Name nilotinib (source: ndc)
Application Number NDA219293 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 95 mg/1
source: ndc
Packaging
  • 4 CARTON in 1 CARTON (24338-155-01) / 2 BLISTER PACK in 1 CARTON (24338-155-02) / 14 TABLET in 1 BLISTER PACK (24338-155-03)
source: ndc

Packages (1)

24338-155-01 4 CARTON in 1 CARTON (24338-155-01) / 2 BLISTER PACK in 1 CARTON (24338-155-02) / 14 TABLET in 1 BLISTER PACK (24338-155-03)

Ingredients (1)

nilotinib (95 mg/1)

Linked Drug Pages (1)

DANZITEN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "62029a35-74af-47bc-9b7b-93dcaddfd278", "openfda": {"nui": ["N0000175605", "N0000020009", "N0000187062", "N0000182137", "N0000187064", "N0000187063", "N0000191272", "N0000185503"], "unii": ["F41401512X"], "rxcui": ["2698564", "2698570", "2698572", "2698574"], "spl_set_id": ["d288d165-3505-49bb-9b2e-124490d65f49"], "pharm_class_epc": ["Kinase Inhibitor [EPC]"], "pharm_class_moa": ["Bcr-Abl Tyrosine Kinase Inhibitors [MoA]", "Cytochrome P450 2C8 Inhibitors [MoA]", "Cytochrome P450 2D6 Inhibitors [MoA]", "Cytochrome P450 2B6 Inducers [MoA]", "Cytochrome P450 2C8 Inducers [MoA]", "UGT1A1 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "manufacturer_name": ["Azurity Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 CARTON in 1 CARTON (24338-155-01)  / 2 BLISTER PACK in 1 CARTON (24338-155-02)  / 14 TABLET in 1 BLISTER PACK (24338-155-03)", "package_ndc": "24338-155-01", "marketing_start_date": "20241130"}], "brand_name": "DANZITEN", "product_id": "24338-155_62029a35-74af-47bc-9b7b-93dcaddfd278", "dosage_form": "TABLET", "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": "24338-155", "generic_name": "nilotinib", "labeler_name": "Azurity Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DANZITEN", "active_ingredients": [{"name": "NILOTINIB", "strength": "95 mg/1"}], "application_number": "NDA219293", "marketing_category": "NDA", "marketing_start_date": "20241130", "listing_expiration_date": "20261231"}