MedPath

SB5 (BIIB606)

Approved
Approval ID

002d3e04-7558-4e22-85bb-09e30566bd0b

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 6, 2023

Manufacturers
FDA

Catalent Indiana, LLC

DUNS: 172209277

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

adalimumab-bwwd

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code61434-005
Product Classification
G
Generic Name
adalimumab-bwwd
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 21, 2022
FDA Product Classification

INGREDIENTS (1)

ADALIMUMAB-BWWDActive
Quantity: 40 mg in 0.8 mL
Code: FYS6T7F842
Classification: ACTIB

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SB5 (BIIB606) - FDA Drug Approval Details