SB5 (BIIB606)

Manufacturer: Catalent Indiana, LLC
Effective date: 2025-08-13
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 12
Source: full-release
Hydrated at: 2026-05-31 21:52:59

Label at a glance#

ProductSB5 (BIIB606)

Active ingredientADALIMUMAB-BWWD

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

168-100-300Case.jpg

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
ADALIMUMAB Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Data code	Data Matrix	ZXXXXXXX		168-100-300Case.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
58819a18-327d-463b-9e5e-26cc1dd9870d	Product name	1	20230313
c1c5a070-0e2e-43dd-af9c-a21585200342	Product name	1	20230104
2a463079-cd68-4798-a3d6-55c4c8578d57	Product name	1	20220728
652f8f6b-479d-477c-848a-374d5b0145b7	Product name	2	20151203

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61434-005-00	SB5 (BIIB606)	1280 in 1 CASE	INJECTION, SOLUTION	1280		12
61434-005-00	SB5 (BIIB606)	0.8 mL in 1 SYRINGE, GLASS	INJECTION, SOLUTION	0.8		12

DailyMed Biologic / Drug Substance Indexing#

Product, Base substance, Indexed substance code table
Product	Base substance	Indexed substance code	Indexed substance	Application	Indexing SPL	SPL version	Effective
CYLTEZO	ADALIMUMAB	FYS6T7F842-ADBM-01	adalimumab-adbm	BLA761058	50885b7e-3977-405d-bc9a-98ff7bfe9d15	1	2017-08-25
AMJEVITA	ADALIMUMAB	FYS6T7F842-ATTO-01	ADALIMUMAB-ATTO	BLA761024	6e8bd80c-8d6e-4006-9b7f-4dfbb583da9f	1	2016-09-23

Products#

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

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

SB5 (BIIB606)
adalimumab-bwwd
ADALIMUMAB

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
61434-005	61434-005-00

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
Name	UNII	Kind
ADALIMUMAB-BWWD	FYS6T7F842	ACTIB

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
3c425d08-4168-a5bc-e063-6394a90a2e95			002d3e04-7558-4e22-85bb-09e30566bd0b	2025-08-13		Exact identifier spl id: 3c425d08-4168-a5bc-e063-6394a90a2e95 spl set id: 002d3e04-7558-4e22-85bb-09e30566bd0b

Reported adverse events (FAERS/openFDA)#

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