PredniSONE
PredniSONE Tablets, USP
Approved
Approval ID
318fdf0d-c03a-4b48-a380-b7bb630363fb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 8, 2023
Manufacturers
FDA
QPharma Inc
DUNS: 030620888
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 Code42708-045
Application NumberANDA084122
Product Classification
M
Marketing Category
C73584
G
Generic Name
PredniSONE
Product Specifications
Route of AdministrationORAL
Effective DateDecember 8, 2023
FDA Product Classification
INGREDIENTS (6)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
PREDNISONEActive
Quantity: 10 mg in 1 1
Code: VB0R961HZT
Classification: ACTIB