Prednisone
PredniSONE Tablets, USP Revised: October 2015 Rx Only
Approved
Approval ID
a1bff575-cd79-4596-99f1-30a5fe8a8b4c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 1, 2022
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 Code63187-997
Application NumberANDA080356
Product Classification
M
Marketing Category
C73584
G
Generic Name
Prednisone
Product Specifications
Route of AdministrationORAL
Effective DateMay 1, 2022
FDA Product Classification
INGREDIENTS (7)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
PREDNISONEActive
Quantity: 5 mg in 1 1
Code: VB0R961HZT
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT