FDA.reportPublic FDA data

NDC 55513-488-40 - LUMAKRAS

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
55513-488
Requested NDC
55513-488-40
Package NDCs from labels
55513-488-01, 55513-488-02, 55513-488-40, 55513-488-24, 55513-488-96
Manufacturer
Amgen Inc
Effective date
2025-01-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
LUMAKRAS - Amgen IncAmgen Inc2025-01-22HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55513-488-01LUMAKRAS120 in 1 BOTTLE, PLASTICTABLET, COATED12019
55513-488-02LUMAKRAS2 in 1 CARTONTABLET, COATED219
55513-488-24LUMAKRAS1 in 1 CARTONTABLET, COATED119
55513-488-40LUMAKRAS240 in 1 BOTTLE, PLASTICTABLET, COATED24019
55513-488-96LUMAKRAS120 in 1 BOTTLE, PLASTICTABLET, COATED12019
55513-488-96LUMAKRAS1 in 1 CARTONTABLET, COATED119

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55513-488LUMAKRAS (SOTORASIB) TABLET, COATED [AMGEN INC]19Current NDC, Legacy NDC, 6 package rows20250130_c80a362c-7ac3-4894-a076-0691e68ef8c1.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55513-488-24EA - Each55513-488cef7c2b0-2546-41f8-8976-03bc4a77c6d612021-07-15
55513-488-40EA - Each55513-488f23e6f9a-26ef-46e2-8ebd-a9c55e0e10de12021-07-15

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 ยท 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
YVTYVT MICRODERMABRASION FACIAL SCRUBYVTYVT MICRODERMABRASION FACIAL SCRUBBeijing JUNGE Technology Co., Ltd.2f30fc45-42e2-c766-e063-6394a90a8d682025-02-28WarningsExact identifier
unii: OP1R32D61U
LUMAKRASSOTORASIBAmgen Incc80a362c-7ac3-4894-a076-0691e68ef8c12025-01-22Warnings, Adverse reactionsExact identifier
application number: NDA214665
ndc (package): 55513-488-02
ndc (package): 55513-512-60
ndc (package): 55513-488-96
ndc (package): 55513-488-01
ndc (package): 55513-488-40
ndc (package): 55513-504-50
ndc (package): 55513-488-24
ndc (product): 55513-504
ndc (product): 55513-512
ndc (product): 55513-488
ndc11 (package): 55513048840
rxcui: 2550725
rxcui: 2550719
rxcui: 2628240
rxcui: 2687207
rxcui: 2628242
rxcui: 2687205
spl id: 8f611e67-8c58-4413-8b81-a200fa7f30e8
spl set id: c80a362c-7ac3-4894-a076-0691e68ef8c1
unii: 2B2VM6UC8G

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.