sorafenib

Generic: sorafenib

Labeler: yabao pharmaceutical co., ltd. beijing
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sorafenib
Generic Name sorafenib
Labeler yabao pharmaceutical co., ltd. beijing
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

sorafenib 200 mg/1

Manufacturer
Yabao Pharmaceutical Co., Ltd. Beijing

Identifiers & Regulatory

Product NDC 51990-201
Product ID 51990-201_4685d90a-e8e2-5c01-e063-6294a90a1439
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 51990201
Hyphenated Format 51990-201

Supplemental Identifiers

RxCUI
597747
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, PLASTIC (51990-201-06)
  • 120 TABLET, FILM COATED in 1 PACKAGE (51990-201-12)
source: ndc

Packages (2)

51990-201-06 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51990-201-06) 51990-201-12 120 TABLET, FILM COATED in 1 PACKAGE (51990-201-12)

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": "4685d90a-e8e2-5c01-e063-6294a90a1439", "openfda": {"nui": ["N0000175605", "N0000175076"], "unii": ["9ZOQ3TZI87"], "rxcui": ["597747"], "spl_set_id": ["06f442d6-071e-4081-b7f7-40f3b803ab3f"], "pharm_class_epc": ["Kinase Inhibitor [EPC]"], "pharm_class_moa": ["Protein Kinase Inhibitors [MoA]"], "manufacturer_name": ["Yabao Pharmaceutical Co., Ltd. Beijing"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51990-201-06)", "package_ndc": "51990-201-06", "marketing_start_date": "20221201"}, {"sample": false, "description": "120 TABLET, FILM COATED in 1 PACKAGE (51990-201-12)", "package_ndc": "51990-201-12", "marketing_start_date": "20221201"}], "brand_name": "sorafenib", "product_id": "51990-201_4685d90a-e8e2-5c01-e063-6294a90a1439", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Kinase Inhibitor [EPC]", "Protein Kinase Inhibitors [MoA]"], "product_ndc": "51990-201", "generic_name": "sorafenib", "labeler_name": "Yabao Pharmaceutical Co., Ltd. Beijing", "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"}