ORFADIN
These highlights do not include all the information needed to use ORFADIN safely and effectively. See full prescribing information for ORFADIN. ORFADIN (nitisinone) capsules, for oral use ORFADIN (nitisinone) oral suspension Initial U.S. Approval: 2002
Approved
Approval ID
00307f42-748d-4227-8c6f-ed5f0a89ae0a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 20, 2022
Manufacturers
FDA
Swedish Orphan Biovitrum AB (publ)
DUNS: 354010589
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
nitisinone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code66658-204
Application NumberNDA206356
Product Classification
M
Marketing Category
C73594
G
Generic Name
nitisinone
Product Specifications
Route of AdministrationORAL
Effective DateJune 20, 2022
FDA Product Classification
INGREDIENTS (8)
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
NITISINONEActive
Quantity: 4 mg in 1 mL
Code: K5BN214699
Classification: ACTIB