Prednisone
Prednisone Tablets, USP Rev. 11/10
Approved
Approval ID
f02ffa5a-1292-4ec9-bb54-e2cd2db4be74
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 30, 2012
Manufacturers
FDA
Unit Dose Services
DUNS: 831995316
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 Code50436-4325
Application NumberANDA088832
Product Classification
M
Marketing Category
C73584
G
Generic Name
Prednisone
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 30, 2012
FDA Product Classification
INGREDIENTS (7)
PREDNISONEActive
Quantity: 10 mg in 1 1
Code: VB0R961HZT
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT