nilotinib

Generic: nilotinib

Labeler: torrent pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nilotinib
Generic Name nilotinib
Labeler torrent pharmaceuticals limited
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

nilotinib hydrochloride monohydrate 200 mg/1

Manufacturer
Torrent Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 13668-711
Product ID 13668-711_8e83f910-85f0-4646-b330-179f02acddf7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218532
Listing Expiration 2026-12-31
Marketing Start 2025-12-16

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 13668711
Hyphenated Format 13668-711

Supplemental Identifiers

RxCUI
746606 997653
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 ANDA218532 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 4 BLISTER PACK in 1 CARTON (13668-711-57) / 28 CAPSULE in 1 BLISTER PACK
  • 1 BLISTER PACK in 1 CARTON (13668-711-91) / 28 CAPSULE in 1 BLISTER PACK
source: ndc

Packages (2)

13668-711-57 4 BLISTER PACK in 1 CARTON (13668-711-57) / 28 CAPSULE in 1 BLISTER PACK 13668-711-91 1 BLISTER PACK in 1 CARTON (13668-711-91) / 28 CAPSULE in 1 BLISTER PACK

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": "8e83f910-85f0-4646-b330-179f02acddf7", "openfda": {"unii": ["5JHU0N1R6K"], "rxcui": ["746606", "997653"], "spl_set_id": ["b34e7fd4-53c5-46d8-bf8a-1fcbe7a16504"], "manufacturer_name": ["Torrent Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 BLISTER PACK in 1 CARTON (13668-711-57)  / 28 CAPSULE in 1 BLISTER PACK", "package_ndc": "13668-711-57", "marketing_start_date": "20251216"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (13668-711-91)  / 28 CAPSULE in 1 BLISTER PACK", "package_ndc": "13668-711-91", "marketing_start_date": "20251216"}], "brand_name": "nilotinib", "product_id": "13668-711_8e83f910-85f0-4646-b330-179f02acddf7", "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": "13668-711", "generic_name": "nilotinib", "labeler_name": "Torrent Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "nilotinib", "active_ingredients": [{"name": "NILOTINIB HYDROCHLORIDE MONOHYDRATE", "strength": "200 mg/1"}], "application_number": "ANDA218532", "marketing_category": "ANDA", "marketing_start_date": "20251216", "listing_expiration_date": "20261231"}