imkeldi

Generic: imatinib oral

Labeler: shorla oncology inc.,
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name imkeldi
Generic Name imatinib oral
Labeler shorla oncology inc.,
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

imatinib mesylate 80 mg/mL

Manufacturer
Shorla Oncology Inc.,

Identifiers & Regulatory

Product NDC 81927-201
Product ID 81927-201_dead98c8-2ac0-4fe6-890a-cc8c92ddcffc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA219097
Listing Expiration 2026-12-31
Marketing Start 2024-12-19

Pharmacologic Class

Classes
bcr-abl tyrosine kinase inhibitors [moa] cytochrome p450 2d6 inhibitors [moa] cytochrome p450 3a4 inhibitors [moa] kinase inhibitor [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 81927201
Hyphenated Format 81927-201

Supplemental Identifiers

RxCUI
2699831 2699837
UNII
8A1O1M485B

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 imkeldi (source: ndc)
Generic Name imatinib oral (source: ndc)
Application Number NDA219097 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 80 mg/mL
source: ndc
Packaging
  • 140 mL in 1 BOTTLE (81927-201-01)
source: ndc

Packages (1)

81927-201-01 140 mL in 1 BOTTLE (81927-201-01)

Ingredients (1)

imatinib mesylate (80 mg/mL)

Linked Drug Pages (1)

IMKELDI ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "dead98c8-2ac0-4fe6-890a-cc8c92ddcffc", "openfda": {"unii": ["8A1O1M485B"], "rxcui": ["2699831", "2699837"], "spl_set_id": ["26658bb7-9ba1-a10e-e063-6394a90a172e"], "manufacturer_name": ["Shorla Oncology Inc.,"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "140 mL in 1 BOTTLE (81927-201-01)", "package_ndc": "81927-201-01", "marketing_start_date": "20241219"}], "brand_name": "IMKELDI", "product_id": "81927-201_dead98c8-2ac0-4fe6-890a-cc8c92ddcffc", "dosage_form": "SOLUTION", "pharm_class": ["Bcr-Abl Tyrosine Kinase Inhibitors [MoA]", "Cytochrome P450 2D6 Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "Kinase Inhibitor [EPC]"], "product_ndc": "81927-201", "generic_name": "imatinib oral", "labeler_name": "Shorla Oncology Inc.,", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "IMKELDI", "active_ingredients": [{"name": "IMATINIB MESYLATE", "strength": "80 mg/mL"}], "application_number": "NDA219097", "marketing_category": "NDA", "marketing_start_date": "20241219", "listing_expiration_date": "20261231"}