MethylPREDNISolone
Methylprednisolone Tablets USP
Approved
Approval ID
a14c4f76-6dd5-4c84-b6e5-e5abf19ab559
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 22, 2023
Manufacturers
FDA
PD-Rx Pharmaceuticals, Inc.
DUNS: 156893695
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 Code55289-649
Application NumberANDA040183
Product Classification
M
Marketing Category
C73584
G
Generic Name
methylprednisolone
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 22, 2023
FDA Product Classification
INGREDIENTS (4)
METHYLPREDNISOLONEActive
Quantity: 4 mg in 1 1
Code: X4W7ZR7023
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT