PREDNISONE
PREDNISONE (D/P) TABLETS, USP 5 mg
Approved
Approval ID
db9b0e3f-11c0-451d-9977-5f2b71ae8c0f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 8, 2012
Manufacturers
FDA
STAT Rx USA LLC
DUNS: 786036330
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 Code16590-365
Application NumberANDA040256
Product Classification
M
Marketing Category
C73584
G
Generic Name
PREDNISONE
Product Specifications
Route of AdministrationORAL
Effective DateOctober 8, 2012
FDA Product Classification
INGREDIENTS (6)
PREDNISONEActive
Quantity: 5 mg in 1 1
Code: VB0R961HZT
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT