nilotinib

Generic: nilotinib

Labeler: cipla usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name nilotinib
Generic Name nilotinib
Labeler cipla usa inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

nilotinib 200 mg/1

Manufacturer
Cipla USA Inc.

Identifiers & Regulatory

Product NDC 69097-032
Product ID 69097-032_d748f03e-56ba-48e2-ae13-e8e74fac55e7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA218922
Listing Expiration 2026-12-31
Marketing Start 2025-06-18

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 69097032
Hyphenated Format 69097-032

Supplemental Identifiers

RxCUI
2715459 2715469 2715473
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 NDA218922 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 4 CARTON in 1 CARTON (69097-032-74) / 4 BLISTER PACK in 1 CARTON (69097-032-56) / 7 CAPSULE in 1 BLISTER PACK (69097-032-17)
  • 4 CARTON in 1 CARTON (69097-032-91) / 2 BLISTER PACK in 1 CARTON (69097-032-73) / 14 CAPSULE in 1 BLISTER PACK (69097-032-76)
source: ndc

Packages (2)

69097-032-74 4 CARTON in 1 CARTON (69097-032-74) / 4 BLISTER PACK in 1 CARTON (69097-032-56) / 7 CAPSULE in 1 BLISTER PACK (69097-032-17) 69097-032-91 4 CARTON in 1 CARTON (69097-032-91) / 2 BLISTER PACK in 1 CARTON (69097-032-73) / 14 CAPSULE in 1 BLISTER PACK (69097-032-76)

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": "d748f03e-56ba-48e2-ae13-e8e74fac55e7", "openfda": {"nui": ["N0000175605", "N0000020009", "N0000187062", "N0000182137", "N0000187064", "N0000187063", "N0000191272", "N0000185503"], "unii": ["F41401512X"], "rxcui": ["2715459", "2715469", "2715473"], "spl_set_id": ["e27c3e09-bc4f-4f01-be05-1c43ac72285d"], "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": ["Cipla USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 CARTON in 1 CARTON (69097-032-74)  / 4 BLISTER PACK in 1 CARTON (69097-032-56)  / 7 CAPSULE in 1 BLISTER PACK (69097-032-17)", "package_ndc": "69097-032-74", "marketing_start_date": "20250618"}, {"sample": false, "description": "4 CARTON in 1 CARTON (69097-032-91)  / 2 BLISTER PACK in 1 CARTON (69097-032-73)  / 14 CAPSULE in 1 BLISTER PACK (69097-032-76)", "package_ndc": "69097-032-91", "marketing_start_date": "20250618"}], "brand_name": "Nilotinib", "product_id": "69097-032_d748f03e-56ba-48e2-ae13-e8e74fac55e7", "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": "69097-032", "generic_name": "Nilotinib", "labeler_name": "Cipla USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nilotinib", "active_ingredients": [{"name": "NILOTINIB", "strength": "200 mg/1"}], "application_number": "NDA218922", "marketing_category": "NDA", "marketing_start_date": "20250618", "listing_expiration_date": "20261231"}