PREDNISONE
PREDNISONE
Approved
Approval ID
8f8cc292-4417-0a3b-e053-2a95a90ace3a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 7, 2019
Manufacturers
FDA
Diect_Rx
DUNS: 079254320
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 Code61919-326
Application NumberANDA085161
Product Classification
M
Marketing Category
C73584
G
Generic Name
PREDNISONE
Product Specifications
Route of AdministrationORAL
Effective DateAugust 7, 2019
FDA Product Classification
INGREDIENTS (8)
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
PREDNISONEActive
Quantity: 20 mg in 1 1
Code: VB0R961HZT
Classification: ACTIB
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT