Prednisone
Approved
Approval ID
5205a8a3-e080-65d9-e054-00144ff88e88
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 20, 2022
Manufacturers
FDA
RedPharm Drug, Inc.
DUNS: 828374897
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 Code67296-1203
Application NumberANDA080356
Product Classification
M
Marketing Category
C73584
G
Generic Name
Prednisone
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 20, 2022
FDA Product Classification
INGREDIENTS (7)
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0
Classification: IACT
PREDNISONEActive
Quantity: 5 mg in 1 1
Code: VB0R961HZT
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT