nilotinib

Generic: nilotinib

Labeler: novadoz pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nilotinib
Generic Name nilotinib
Labeler novadoz pharmaceuticals llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

nilotinib 200 mg/1

Manufacturer
Novadoz Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 72205-239
Product ID 72205-239_13b46e09-62d2-4ce9-b3c0-deafcb1f1842
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218544
Listing Expiration 2026-12-31
Marketing Start 2025-11-19

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 72205239
Hyphenated Format 72205-239

Supplemental Identifiers

RxCUI
746606 997653 2002717
UPC
0372205237926 0372205239630 0372205238640 0372205239647
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 nilotinib (source: ndc)
Generic Name nilotinib (source: ndc)
Application Number ANDA218544 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 28 CAPSULE in 1 BLISTER PACK (72205-239-63)
  • 4 BLISTER PACK in 1 CARTON (72205-239-64) / 28 CAPSULE in 1 BLISTER PACK
source: ndc

Packages (2)

72205-239-63 28 CAPSULE in 1 BLISTER PACK (72205-239-63) 72205-239-64 4 BLISTER PACK in 1 CARTON (72205-239-64) / 28 CAPSULE in 1 BLISTER PACK

Ingredients (1)

nilotinib (200 mg/1)

Linked Drug Pages (1)

nilotinib ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "13b46e09-62d2-4ce9-b3c0-deafcb1f1842", "openfda": {"nui": ["N0000175605", "N0000020009", "N0000187062", "N0000182137", "N0000187064", "N0000187063", "N0000191272", "N0000185503"], "upc": ["0372205237926", "0372205239630", "0372205238640", "0372205239647"], "unii": ["F41401512X"], "rxcui": ["746606", "997653", "2002717"], "spl_set_id": ["13b46e09-62d2-4ce9-b3c0-deafcb1f1842"], "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": ["Novadoz Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "28 CAPSULE in 1 BLISTER PACK (72205-239-63)", "package_ndc": "72205-239-63", "marketing_start_date": "20251120"}, {"sample": false, "description": "4 BLISTER PACK in 1 CARTON (72205-239-64)  / 28 CAPSULE in 1 BLISTER PACK", "package_ndc": "72205-239-64", "marketing_start_date": "20251120"}], "brand_name": "nilotinib", "product_id": "72205-239_13b46e09-62d2-4ce9-b3c0-deafcb1f1842", "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": "72205-239", "generic_name": "nilotinib", "labeler_name": "Novadoz Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "nilotinib", "active_ingredients": [{"name": "NILOTINIB", "strength": "200 mg/1"}], "application_number": "ANDA218544", "marketing_category": "ANDA", "marketing_start_date": "20251119", "listing_expiration_date": "20261231"}