Baricitinib
BARICITINIB tablets, for oral use Emergency Use Authorization
Approved
Approval ID
7052c055-fedf-453b-86bc-01f5465eb157
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 10, 2022
Manufacturers
FDA
Eli Lilly and Company
DUNS: 006421325
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
baricitinib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0002-6885
Product Classification
G
Generic Name
baricitinib
Product Specifications
Route of AdministrationORAL
Effective DateDecember 20, 2021
FDA Product Classification
INGREDIENTS (5)
MannitolInactive
Quantity: 50 mg in 1 1
Code: 3OWL53L36A
Classification: IACT
Cellulose, MicrocrystallineInactive
Quantity: 132 mg in 1 1
Code: OP1R32D61U
Classification: IACT
baricitinibActive
Quantity: 4 mg in 1 1
Code: ISP4442I3Y
Classification: ACTIB
Magnesium StearateInactive
Quantity: 2 mg in 1 1
Code: 70097M6I30
Classification: IACT
Croscarmellose SodiumInactive
Quantity: 12 mg in 1 1
Code: M28OL1HH48
Classification: IACT