PredniSONE
Approved
Approval ID
42897c99-311e-55bf-e054-00144ff8d46c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 19, 2022
Manufacturers
FDA
RedPharm Drug, Inc.
DUNS: 828374897
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
PredniSONE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67296-0247
Application NumberANDA087342
Product Classification
M
Marketing Category
C73584
G
Generic Name
PredniSONE
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 19, 2022
FDA Product Classification
INGREDIENTS (6)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM GLYCOLATEInactive
Code: B75E535IMI
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
PREDNISONEActive
Quantity: 20 mg in 1 1
Code: VB0R961HZT
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT