FDA.reportPublic FDA data

NDC 63833-925-20 - ANDEMBRY

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
63833-925
Requested NDC
63833-925-20
Package NDCs from labels
63833-925-20, 63833-925-01
Manufacturer
CSL
Effective date
2025-06-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ANDEMBRY - CSLCSL2025-06-30HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63833-925-01ANDEMBRY1 in 1 CARTONINJECTION, SOLUTION15
63833-925-20ANDEMBRY1.2 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION1.25

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63833-925-01ML - Milliliter63833-92574e0dbd7-792a-4744-86ab-2893c2a3befd12025-07-08
63833-925-20ML - Milliliter63833-925cb4a2885-d34f-4fa1-8ab3-fbb712e20b2712025-07-08

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 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ANDEMBRYGARADACIMABCSL07b0b671-db81-49f0-a402-0c0219db7fa22025-06-30Warnings, Adverse reactionsExact identifier
application number: BLA761367
ndc (package): 63833-925-20
ndc (package): 63833-925-01
ndc (product): 63833-925
ndc11 (package): 63833092520
rxcui: 2717175
rxcui: 2717182
spl id: a15c0e04-117a-434d-8b34-b664701b787f
spl set id: 07b0b671-db81-49f0-a402-0c0219db7fa2
unii: 32W6AJL0DY

Reported adverse events (FAERS/openFDA)#

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