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MethylPREDNISolone

MethylPREDNISolone TABLETS, USP 4 mg

Approved
Approval ID

2eb5d8c3-87dd-47dc-9619-461dfb7ba935

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 22, 2011

Manufacturers
FDA

Dispensing Solutions, Inc.

DUNS: 066070785

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 Code55045-1259
Application NumberANDA040183
Product Classification
M
Marketing Category
C73584
G
Generic Name
methylprednisolone
Product Specifications
Route of AdministrationORAL
Effective DateAugust 22, 2011
FDA Product Classification

INGREDIENTS (4)

CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
METHYLPREDNISOLONEActive
Quantity: 4 mg in 1 1
Code: X4W7ZR7023
Classification: ACTIB

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MethylPREDNISolone - FDA Drug Approval Details