PREDNISONE
Prednisone 10mg tablet
Approved
Approval ID
a344efe6-fad3-f5d3-e053-2a95a90a30a6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 21, 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 Code67296-1767
Application NumberANDA210525
Product Classification
M
Marketing Category
C73584
G
Generic Name
Prednisone
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 21, 2022
FDA Product Classification
INGREDIENTS (6)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
PREDNISONEActive
Quantity: 10 mg in 1 1
Code: VB0R961HZT
Classification: ACTIB