Methylprednisolone
Methylprednisolone tablets, USP
Approved
Approval ID
0d807b7a-2942-4b13-b3c5-a585ff56fe32
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 10, 2010
Manufacturers
FDA
Keltman Pharmaceuticals Inc.
DUNS: 362861077
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
methylprednisolone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68387-170
Application NumberNDA011153
Product Classification
M
Marketing Category
C73594
G
Generic Name
methylprednisolone
Product Specifications
Route of AdministrationORAL
Effective DateAugust 10, 2010
FDA Product Classification
INGREDIENTS (9)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
METHYLPREDNISOLONEActive
Quantity: 4 mg in 1 1
Code: X4W7ZR7023
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT