methylprednisolone
Methylprednisolone Tablets USP
Approved
Approval ID
c5cbcea1-2200-4fc0-a49a-35edd9434873
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 8, 2021
Manufacturers
FDA
Lupin Pharmaceuticals, Inc.
DUNS: 089153071
Products 5
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 Code68180-689
Application NumberANDA209097
Product Classification
M
Marketing Category
C73584
G
Generic Name
methylprednisolone
Product Specifications
Route of AdministrationORAL
Effective DateDecember 8, 2021
FDA Product Classification
INGREDIENTS (7)
METHYLPREDNISOLONEActive
Quantity: 32 mg in 1 1
Code: X4W7ZR7023
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE 2910 (15000 MPA.S)Inactive
Code: 288VBX44JC
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
methylprednisolone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68180-688
Application NumberANDA209097
Product Classification
M
Marketing Category
C73584
G
Generic Name
methylprednisolone
Product Specifications
Route of AdministrationORAL
Effective DateDecember 8, 2021
FDA Product Classification
INGREDIENTS (7)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
METHYLPREDNISOLONEActive
Quantity: 16 mg in 1 1
Code: X4W7ZR7023
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSE 2910 (15000 MPA.S)Inactive
Code: 288VBX44JC
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
methylprednisolone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68180-687
Application NumberANDA209097
Product Classification
M
Marketing Category
C73584
G
Generic Name
methylprednisolone
Product Specifications
Route of AdministrationORAL
Effective DateDecember 8, 2021
FDA Product Classification
INGREDIENTS (7)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE 2910 (15000 MPA.S)Inactive
Code: 288VBX44JC
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
METHYLPREDNISOLONEActive
Quantity: 8 mg in 1 1
Code: X4W7ZR7023
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
methylprednisolone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68180-686
Application NumberANDA209097
Product Classification
M
Marketing Category
C73584
G
Generic Name
methylprednisolone
Product Specifications
Route of AdministrationORAL
Effective DateDecember 8, 2021
FDA Product Classification
INGREDIENTS (7)
METHYLPREDNISOLONEActive
Quantity: 4 mg in 1 1
Code: X4W7ZR7023
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (15000 MPA.S)Inactive
Code: 288VBX44JC
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
methylprednisolone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68180-685
Application NumberANDA209097
Product Classification
M
Marketing Category
C73584
G
Generic Name
methylprednisolone
Product Specifications
Route of AdministrationORAL
Effective DateDecember 8, 2021
FDA Product Classification
INGREDIENTS (7)
METHYLPREDNISOLONEActive
Quantity: 2 mg in 1 1
Code: X4W7ZR7023
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSE 2910 (15000 MPA.S)Inactive
Code: 288VBX44JC
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT