Prednisone
PredniSONE Tablets, USP1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg
Approved
Approval ID
55aedced-d945-4bd2-9aa8-0f18b89a0e7f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 22, 2023
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 Code63629-2257
Application NumberANDA040256
Product Classification
M
Marketing Category
C73584
G
Generic Name
Prednisone
Product Specifications
Route of AdministrationORAL
Effective DateDecember 17, 2019
FDA Product Classification
INGREDIENTS (6)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
PREDNISONEActive
Quantity: 10 mg in 1 1
Code: VB0R961HZT
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT