Prednisone
PredniSONE TABLETS, USP5 mg and 10 mg
Approved
Approval ID
d3abe47f-8ad5-4752-b772-97b56cca19f2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 10, 2010
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
Products 2
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 Code21695-764
Application NumberANDA040256
Product Classification
M
Marketing Category
C73584
G
Generic Name
prednisone
Product Specifications
Route of AdministrationORAL
Effective DateApril 11, 2008
FDA Product Classification
INGREDIENTS (6)
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
prednisoneActive
Quantity: 5 mg in 1 1
Code: VB0R961HZT
Classification: ACTIB
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
prednisone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-765
Application NumberANDA040256
Product Classification
M
Marketing Category
C73584
G
Generic Name
prednisone
Product Specifications
Route of AdministrationORAL
Effective DateApril 11, 2008
FDA Product Classification
INGREDIENTS (6)
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
prednisoneActive
Quantity: 10 mg in 1 1
Code: VB0R961HZT
Classification: ACTIB
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT