MedPath

Methylprednisolone

METHYLPREDNISOLONE TABLETS, USP Rx only

Approved
Approval ID

6beebbfd-4846-49ec-8f5b-62e2c23c468c

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 1, 2009

Manufacturers
FDA

Rebel Distributors Corp.

DUNS: 118802834

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 Code21695-080
Application NumberANDA040189
Product Classification
M
Marketing Category
C73584
G
Generic Name
Methylprednisolone
Product Specifications
Route of AdministrationORAL
Effective DateJune 1, 2009
FDA Product Classification

INGREDIENTS (8)

silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
MethylprednisoloneActive
Quantity: 4 mg in 1 1
Code: X4W7ZR7023
Classification: ACTIM
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
Magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
Cellulose, MicrocrystallineInactive
Code: OP1R32D61U
Classification: IACT
Sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Methylprednisolone - FDA Drug Approval Details