MedPath

Methylprednisolone

Methylprednisolone Tablets, USP

Approved
Approval ID

9da7dd02-0837-4264-b6eb-9212565eb2d7

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 28, 2010

Manufacturers
FDA

Altura Pharmaceuticals, Inc.

DUNS: 006890545

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 Code63874-413
Application NumberNDA011757
Product Classification
M
Marketing Category
C73594
G
Generic Name
methylprednisolone
Product Specifications
Route of AdministrationORAL
Effective DateApril 28, 2010
FDA Product Classification

INGREDIENTS (7)

METHYLPREDNISOLONEActive
Quantity: 4 mg in 1 1
Code: X4W7ZR7023
Classification: ACTIB
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
SORBIC ACIDInactive
Code: X045WJ989B
Classification: IACT
SUCROSEInactive
Code: C151H8M554
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