METHYLPREDNISOLONE
Approved
Approval ID
807273be-f765-48f0-bd2e-94f9f70152bd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 31, 2011
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-6624
Application NumberANDA040232
Product Classification
M
Marketing Category
C73584
G
Generic Name
methylprednisolone
Product Specifications
Route of AdministrationORAL
Effective DateMarch 31, 2011
FDA Product Classification
INGREDIENTS (8)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
METHYLPREDNISOLONEActive
Quantity: 4 mg in 1 1
Code: X4W7ZR7023
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT