FDA.reportPublic FDA data

Abrilada

Manufacturer
Catalent Indiana, LLC
Effective date
2023-07-06
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 21:29:10

Label at a glance#

ProductAbrilada
Active ingredientADALIMUMAB-AFZB
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

127-102-303 0.4mLCarton127-102-303 0.4mLCarton127-102-303 0.4mLCase127-102-303 0.4mLCase

DailyMed Biologic / Drug Substance Indexing#

Product, Base substance, Indexed substance code table
ProductBase substanceIndexed substance codeIndexed substanceApplicationIndexing SPLSPL versionEffective
CYLTEZOADALIMUMABFYS6T7F842-ADBM-01adalimumab-adbmBLA76105850885b7e-3977-405d-bc9a-98ff7bfe9d1512017-08-25
AMJEVITAADALIMUMABFYS6T7F842-ATTO-01ADALIMUMAB-ATTOBLA7610246e8bd80c-8d6e-4006-9b7f-4dfbb583da9f12016-09-23

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61434-05361434-053-00

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
ADALIMUMAB-AFZBFYS6T7F842ACTIB

Source Document#

Source XML

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
16c2517e-623a-4c5c-a714-017c71f65d5df2ee682a-8ea6-4068-bdbe-8a9e7d1a25142023-09-26Exact identifier
spl set id: f2ee682a-8ea6-4068-bdbe-8a9e7d1a2514

Reported adverse events (FAERS/openFDA)#

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