Medrol
Medrol methylprednisolone tablets, USP
Approved
Approval ID
39d5270b-d957-4821-93d6-501b7b9f02d4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 4, 2024
Manufacturers
FDA
Pharmacia & Upjohn Company LLC
DUNS: 618054084
Products 6
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 Code0009-0176
Application NumberNDA011153
Product Classification
M
Marketing Category
C73594
G
Generic Name
methylprednisolone
Product Specifications
Route of AdministrationORAL
Effective DateDecember 1, 2023
FDA Product Classification
INGREDIENTS (6)
METHYLPREDNISOLONEActive
Quantity: 32 mg in 1 1
Code: X4W7ZR7023
Classification: ACTIB
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
methylprednisolone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0009-0056
Application NumberNDA011153
Product Classification
M
Marketing Category
C73594
G
Generic Name
methylprednisolone
Product Specifications
Route of AdministrationORAL
Effective DateDecember 1, 2023
FDA Product Classification
INGREDIENTS (5)
METHYLPREDNISOLONEActive
Quantity: 4 mg in 1 1
Code: X4W7ZR7023
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
methylprednisolone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0009-0020
Application NumberNDA011153
Product Classification
M
Marketing Category
C73594
G
Generic Name
methylprednisolone
Product Specifications
Route of AdministrationORAL
Effective DateDecember 1, 2023
FDA Product Classification
INGREDIENTS (7)
METHYLPREDNISOLONEActive
Quantity: 2 mg in 1 1
Code: X4W7ZR7023
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
SORBIC ACIDInactive
Code: X045WJ989B
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
methylprednisolone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0009-0022
Application NumberNDA011153
Product Classification
M
Marketing Category
C73594
G
Generic Name
methylprednisolone
Product Specifications
Route of AdministrationORAL
Effective DateDecember 1, 2023
FDA Product Classification
INGREDIENTS (5)
METHYLPREDNISOLONEActive
Quantity: 8 mg in 1 1
Code: X4W7ZR7023
Classification: ACTIB
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
methylprednisolone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0009-0073
Application NumberNDA011153
Product Classification
M
Marketing Category
C73594
G
Generic Name
methylprednisolone
Product Specifications
Route of AdministrationORAL
Effective DateDecember 1, 2023
FDA Product Classification
INGREDIENTS (6)
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
METHYLPREDNISOLONEActive
Quantity: 16 mg in 1 1
Code: X4W7ZR7023
Classification: ACTIB
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
methylprednisolone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0009-0049
Application NumberNDA011153
Product Classification
M
Marketing Category
C73594
G
Generic Name
methylprednisolone
Product Specifications
Route of AdministrationORAL
Effective DateDecember 1, 2023
FDA Product Classification
INGREDIENTS (8)
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SORBIC ACIDInactive
Code: X045WJ989B
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
METHYLPREDNISOLONEActive
Quantity: 2 mg in 1 1
Code: X4W7ZR7023
Classification: ACTIB
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT