prednisone
PredniSONE Tablets, USP (10 mg) Rx only
Approved
Approval ID
6ec5b58c-65e9-47ee-b2ac-7d0b395a0630
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 1, 2023
Manufacturers
FDA
Proficient Rx LP
DUNS: 079196022
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 Code71205-818
Application NumberANDA213386
Product Classification
M
Marketing Category
C73584
G
Generic Name
prednisone
Product Specifications
Route of AdministrationORAL
Effective DateJuly 1, 2023
FDA Product Classification
INGREDIENTS (6)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
PREDNISONEActive
Quantity: 10 mg in 1 1
Code: VB0R961HZT
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT