PredniSONE
PredniSONE Tablets, USP PredniSONE Oral Solution, USP PredniSONE ™ Oral Solution (Concentrate)
Approved
Approval ID
da6fce58-0ef9-f3b1-e053-2995a90a1bec
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 1, 2023
Manufacturers
FDA
Northwind Pharmaceuticals
DUNS: 036986393
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 Code51655-763
Application NumberANDA087801
Product Classification
M
Marketing Category
C73584
G
Generic Name
PredniSONE
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 1, 2023
FDA Product Classification
INGREDIENTS (7)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
PREDNISONEActive
Quantity: 2.5 mg in 1 1
Code: VB0R961HZT
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT