lumakras

Generic: sotorasib

Labeler: amgen inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name lumakras
Generic Name sotorasib
Labeler amgen inc
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

sotorasib 120 mg/1

Manufacturer
Amgen Inc

Identifiers & Regulatory

Product NDC 55513-488
Product ID 55513-488_8f611e67-8c58-4413-8b81-a200fa7f30e8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA214665
Listing Expiration 2026-12-31
Marketing Start 2021-05-28

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55513488
Hyphenated Format 55513-488

Supplemental Identifiers

RxCUI
2550719 2550725 2628240 2628242 2687205 2687207
UPC
0355513488020 0000000000000 0355513488242 0355513504508
UNII
2B2VM6UC8G

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 lumakras (source: ndc)
Generic Name sotorasib (source: ndc)
Application Number NDA214665 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 120 mg/1
source: ndc
Packaging
  • 2 BOTTLE, PLASTIC in 1 CARTON (55513-488-02) / 120 TABLET, COATED in 1 BOTTLE, PLASTIC (55513-488-01)
  • 1 BOTTLE, PLASTIC in 1 CARTON (55513-488-24) / 240 TABLET, COATED in 1 BOTTLE, PLASTIC (55513-488-40)
  • 1 BOTTLE, PLASTIC in 1 CARTON (55513-488-96) / 120 TABLET, COATED in 1 BOTTLE, PLASTIC
source: ndc

Packages (3)

55513-488-02 2 BOTTLE, PLASTIC in 1 CARTON (55513-488-02) / 120 TABLET, COATED in 1 BOTTLE, PLASTIC (55513-488-01) 55513-488-24 1 BOTTLE, PLASTIC in 1 CARTON (55513-488-24) / 240 TABLET, COATED in 1 BOTTLE, PLASTIC (55513-488-40) 55513-488-96 1 BOTTLE, PLASTIC in 1 CARTON (55513-488-96) / 120 TABLET, COATED in 1 BOTTLE, PLASTIC

Ingredients (1)

sotorasib (120 mg/1)

Linked Drug Pages (1)

LUMAKRAS ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "8f611e67-8c58-4413-8b81-a200fa7f30e8", "openfda": {"upc": ["0355513488020", "0000000000000", "0355513488242", "0355513504508"], "unii": ["2B2VM6UC8G"], "rxcui": ["2550719", "2550725", "2628240", "2628242", "2687205", "2687207"], "spl_set_id": ["c80a362c-7ac3-4894-a076-0691e68ef8c1"], "manufacturer_name": ["Amgen Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BOTTLE, PLASTIC in 1 CARTON (55513-488-02)  / 120 TABLET, COATED in 1 BOTTLE, PLASTIC (55513-488-01)", "package_ndc": "55513-488-02", "marketing_start_date": "20210528"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (55513-488-24)  / 240 TABLET, COATED in 1 BOTTLE, PLASTIC (55513-488-40)", "package_ndc": "55513-488-24", "marketing_start_date": "20210528"}, {"sample": true, "description": "1 BOTTLE, PLASTIC in 1 CARTON (55513-488-96)  / 120 TABLET, COATED in 1 BOTTLE, PLASTIC", "package_ndc": "55513-488-96", "marketing_start_date": "20210528"}], "brand_name": "LUMAKRAS", "product_id": "55513-488_8f611e67-8c58-4413-8b81-a200fa7f30e8", "dosage_form": "TABLET, COATED", "product_ndc": "55513-488", "generic_name": "sotorasib", "labeler_name": "Amgen Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LUMAKRAS", "active_ingredients": [{"name": "SOTORASIB", "strength": "120 mg/1"}], "application_number": "NDA214665", "marketing_category": "NDA", "marketing_start_date": "20210528", "listing_expiration_date": "20261231"}