Isosorbide Mononitrate
Isosorbide Mononitrate Extended-Release Tablets Rx only
Approved
Approval ID
cd953cfa-b6f5-4b82-afcc-52a57236b9d3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 22, 2023
Manufacturers
FDA
Shandong New Time Pharmaceutical Co., Ltd.
DUNS: 545298254
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Isosorbide Mononitrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42677-305
Application NumberANDA214115
Product Classification
M
Marketing Category
C73584
G
Generic Name
Isosorbide Mononitrate
Product Specifications
Route of AdministrationORAL
Effective DateMay 7, 2025
FDA Product Classification
INGREDIENTS (7)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSE 2208 (100000 MPA.S)Inactive
Code: VM7F0B23ZI
Classification: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEY
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ISOSORBIDE MONONITRATEActive
Quantity: 30 mg in 1 1
Code: LX1OH63030
Classification: ACTIB
Isosorbide Mononitrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42677-306
Application NumberANDA214115
Product Classification
M
Marketing Category
C73584
G
Generic Name
Isosorbide Mononitrate
Product Specifications
Route of AdministrationORAL
Effective DateMay 7, 2025
FDA Product Classification
INGREDIENTS (7)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSE 2208 (100000 MPA.S)Inactive
Code: VM7F0B23ZI
Classification: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEY
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ISOSORBIDE MONONITRATEActive
Quantity: 60 mg in 1 1
Code: LX1OH63030
Classification: ACTIB
Isosorbide Mononitrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42677-307
Application NumberANDA214115
Product Classification
M
Marketing Category
C73584
G
Generic Name
Isosorbide Mononitrate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 22, 2023
FDA Product Classification
INGREDIENTS (8)
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSE 2208 (100 MPA.S)Inactive
Code: B1QE5P712K
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEY
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ISOSORBIDE MONONITRATEActive
Quantity: 120 mg in 1 1
Code: LX1OH63030
Classification: ACTIB
HYPROMELLOSE 2208 (100000 MPA.S)Inactive
Code: VM7F0B23ZI
Classification: IACT