sorafenib

Generic: sorafenib

Labeler: dr.reddys laboratories inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sorafenib
Generic Name sorafenib
Labeler dr.reddys laboratories inc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

sorafenib tosylate 200 mg/1

Manufacturer
Dr.Reddys Laboratories Inc

Identifiers & Regulatory

Product NDC 43598-458
Product ID 43598-458_8ad2e151-bfb3-30bc-f24b-928f5f626f1d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216073
Listing Expiration 2026-12-31
Marketing Start 2022-06-08

Pharmacologic Class

Classes
kinase inhibitor [epc] protein kinase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43598458
Hyphenated Format 43598-458

Supplemental Identifiers

RxCUI
597747
UPC
0343598458045
UNII
5T62Q3B36J

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 ANDA216073 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 120 TABLET, FILM COATED in 1 BOTTLE (43598-458-04)
  • 360 TABLET, FILM COATED in 1 BOTTLE (43598-458-36)
source: ndc

Packages (2)

43598-458-04 120 TABLET, FILM COATED in 1 BOTTLE (43598-458-04) 43598-458-36 360 TABLET, FILM COATED in 1 BOTTLE (43598-458-36)

Ingredients (1)

sorafenib tosylate (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": "8ad2e151-bfb3-30bc-f24b-928f5f626f1d", "openfda": {"upc": ["0343598458045"], "unii": ["5T62Q3B36J"], "rxcui": ["597747"], "spl_set_id": ["93f9c3b2-d4c5-80d3-5421-8b4c29fbf8a6"], "manufacturer_name": ["Dr.Reddys Laboratories Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE (43598-458-04)", "package_ndc": "43598-458-04", "marketing_start_date": "20220608"}, {"sample": false, "description": "360 TABLET, FILM COATED in 1 BOTTLE (43598-458-36)", "package_ndc": "43598-458-36", "marketing_start_date": "20220608"}], "brand_name": "sorafenib", "product_id": "43598-458_8ad2e151-bfb3-30bc-f24b-928f5f626f1d", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Kinase Inhibitor [EPC]", "Protein Kinase Inhibitors [MoA]"], "product_ndc": "43598-458", "generic_name": "sorafenib", "labeler_name": "Dr.Reddys Laboratories Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "sorafenib", "active_ingredients": [{"name": "SORAFENIB TOSYLATE", "strength": "200 mg/1"}], "application_number": "ANDA216073", "marketing_category": "ANDA", "marketing_start_date": "20220608", "listing_expiration_date": "20261231"}