sorafenib

Generic: sorafenib

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

Drug Facts

Product Profile

Brand Name sorafenib
Generic Name sorafenib
Labeler torrent pharmaceuticals limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

sorafenib 200 mg/1

Manufacturer
Torrent Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 13668-682
Product ID 13668-682_27389dc4-60cc-4c65-92e6-97bcc09f7d20
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217095
Listing Expiration 2027-12-31
Marketing Start 2023-04-12

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 13668682
Hyphenated Format 13668-682

Supplemental Identifiers

RxCUI
597747
UPC
0313668682304
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 ANDA217095 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (13668-682-12)
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (13668-682-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (13668-682-60)
  • 10 BLISTER PACK in 1 CARTON (13668-682-74) / 10 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (4)

13668-682-12 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (13668-682-12) 13668-682-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (13668-682-30) 13668-682-60 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (13668-682-60) 13668-682-74 10 BLISTER PACK in 1 CARTON (13668-682-74) / 10 TABLET, FILM COATED in 1 BLISTER PACK

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": "27389dc4-60cc-4c65-92e6-97bcc09f7d20", "openfda": {"nui": ["N0000175605", "N0000175076"], "upc": ["0313668682304"], "unii": ["9ZOQ3TZI87"], "rxcui": ["597747"], "spl_set_id": ["b5305e23-7bc6-44d8-b177-930c47d1653a"], "pharm_class_epc": ["Kinase Inhibitor [EPC]"], "pharm_class_moa": ["Protein Kinase Inhibitors [MoA]"], "manufacturer_name": ["Torrent Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (13668-682-12)", "package_ndc": "13668-682-12", "marketing_start_date": "20230412"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (13668-682-30)", "package_ndc": "13668-682-30", "marketing_start_date": "20230412"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (13668-682-60)", "package_ndc": "13668-682-60", "marketing_start_date": "20230412"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (13668-682-74)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "13668-682-74", "marketing_start_date": "20230412"}], "brand_name": "Sorafenib", "product_id": "13668-682_27389dc4-60cc-4c65-92e6-97bcc09f7d20", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Kinase Inhibitor [EPC]", "Protein Kinase Inhibitors [MoA]"], "product_ndc": "13668-682", "generic_name": "sorafenib", "labeler_name": "Torrent Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sorafenib", "active_ingredients": [{"name": "SORAFENIB", "strength": "200 mg/1"}], "application_number": "ANDA217095", "marketing_category": "ANDA", "marketing_start_date": "20230412", "listing_expiration_date": "20271231"}