Prednisone
PredniSONE Tablets, USP 2.5mg, 5mg, 10mg, 20mg & 50mg Rx only
Approved
Approval ID
7ea7f6a9-78ef-42fe-baac-f817da3976fb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 28, 2022
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
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 Code71335-1780
Application NumberANDA211575
Product Classification
M
Marketing Category
C73584
G
Generic Name
Prednisone
Product Specifications
Route of AdministrationORAL
Effective DateJuly 7, 2022
FDA Product Classification
INGREDIENTS (7)
PREDNISONEActive
Quantity: 5 mg in 1 1
Code: VB0R961HZT
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT