sorafenib

Generic: sorafenib

Labeler: upsher-smith laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sorafenib
Generic Name sorafenib
Labeler upsher-smith laboratories, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

sorafenib 200 mg/1

Manufacturer
Upsher-Smith Laboratories, LLC

Identifiers & Regulatory

Product NDC 24979-715
Product ID 24979-715_4685e399-b323-4da9-e063-6294a90af931
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209050
Listing Expiration 2026-12-31
Marketing Start 2022-12-01

Pharmacologic Class

Established (EPC)
kinase inhibitor [epc]
Mechanism of Action
protein kinase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 24979715
Hyphenated Format 24979-715

Supplemental Identifiers

RxCUI
597747
UPC
0324979715445
UNII
9ZOQ3TZI87
NUI
N0000175605 N0000175076

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 sorafenib (source: ndc)
Generic Name sorafenib (source: ndc)
Application Number ANDA209050 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE (24979-715-04)
  • 120 TABLET, FILM COATED in 1 BOTTLE (24979-715-44)
source: ndc

Packages (2)

24979-715-04 60 TABLET, FILM COATED in 1 BOTTLE (24979-715-04) 24979-715-44 120 TABLET, FILM COATED in 1 BOTTLE (24979-715-44)

Ingredients (1)

sorafenib (200 mg/1)

Linked Drug Pages (1)

sorafenib ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4685e399-b323-4da9-e063-6294a90af931", "openfda": {"nui": ["N0000175605", "N0000175076"], "upc": ["0324979715445"], "unii": ["9ZOQ3TZI87"], "rxcui": ["597747"], "spl_set_id": ["68aa4b7f-3f13-4e73-b572-aa6c11a8429c"], "pharm_class_epc": ["Kinase Inhibitor [EPC]"], "pharm_class_moa": ["Protein Kinase Inhibitors [MoA]"], "manufacturer_name": ["Upsher-Smith Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (24979-715-04)", "package_ndc": "24979-715-04", "marketing_start_date": "20221201"}, {"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE (24979-715-44)", "package_ndc": "24979-715-44", "marketing_start_date": "20221201"}], "brand_name": "sorafenib", "product_id": "24979-715_4685e399-b323-4da9-e063-6294a90af931", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Kinase Inhibitor [EPC]", "Protein Kinase Inhibitors [MoA]"], "product_ndc": "24979-715", "generic_name": "sorafenib", "labeler_name": "Upsher-Smith Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "sorafenib", "active_ingredients": [{"name": "SORAFENIB", "strength": "200 mg/1"}], "application_number": "ANDA209050", "marketing_category": "ANDA", "marketing_start_date": "20221201", "listing_expiration_date": "20261231"}