nilotinib

Generic: nilotinib

Labeler: dr. reddy's laboratories inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nilotinib
Generic Name nilotinib
Labeler dr. reddy's laboratories inc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

nilotinib hydrochloride monohydrate 200 mg/1

Manufacturer
Dr. Reddy's Laboratories Inc

Identifiers & Regulatory

Product NDC 43598-456
Product ID 43598-456_0e4d3a09-2813-d066-3d1b-2a7e0b196fd5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218350
Listing Expiration 2026-12-31
Marketing Start 2025-11-19

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 43598456
Hyphenated Format 43598-456

Supplemental Identifiers

RxCUI
746606 997653 2002717
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 nilotinib (source: ndc)
Generic Name nilotinib (source: ndc)
Application Number ANDA218350 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 8 BLISTER PACK in 1 CARTON (43598-456-46) / 14 CAPSULE in 1 BLISTER PACK (43598-456-74)
source: ndc

Packages (1)

43598-456-46 8 BLISTER PACK in 1 CARTON (43598-456-46) / 14 CAPSULE in 1 BLISTER PACK (43598-456-74)

Ingredients (1)

nilotinib hydrochloride monohydrate (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": "0e4d3a09-2813-d066-3d1b-2a7e0b196fd5", "openfda": {"unii": ["5JHU0N1R6K"], "rxcui": ["746606", "997653", "2002717"], "spl_set_id": ["805cc504-60bb-7743-5ada-679eb3badc7f"], "manufacturer_name": ["Dr. Reddy's Laboratories Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "8 BLISTER PACK in 1 CARTON (43598-456-46)  / 14 CAPSULE in 1 BLISTER PACK (43598-456-74)", "package_ndc": "43598-456-46", "marketing_start_date": "20251119"}], "brand_name": "Nilotinib", "product_id": "43598-456_0e4d3a09-2813-d066-3d1b-2a7e0b196fd5", "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": "43598-456", "generic_name": "Nilotinib", "labeler_name": "Dr. Reddy's Laboratories Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nilotinib", "active_ingredients": [{"name": "NILOTINIB HYDROCHLORIDE MONOHYDRATE", "strength": "200 mg/1"}], "application_number": "ANDA218350", "marketing_category": "ANDA", "marketing_start_date": "20251119", "listing_expiration_date": "20261231"}