Isosorbide Mononitrate
Isosorbide Mononitrate Extended-Release Tablets, USP Rx only
Approved
Approval ID
b38f43c8-d02d-4aee-ab23-e898cbfadfbc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 2, 2023
Manufacturers
FDA
Chartwell RX, LLC
DUNS: 079394054
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 Code62135-588
Application NumberANDA210822
Product Classification
M
Marketing Category
C73584
G
Generic Name
Isosorbide Mononitrate
Product Specifications
Route of AdministrationORAL
Effective DateMay 2, 2023
FDA Product Classification
INGREDIENTS (7)
HYDROXYPROPYL CELLULOSE (430000 WAMW)Inactive
Code: VQ8ZWO78F6
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSE 2208 (100 MPA.S)Inactive
Code: B1QE5P712K
Classification: IACT
ISOSORBIDE MONONITRATEActive
Quantity: 120 mg in 1 1
Code: LX1OH63030
Classification: ACTIB
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Isosorbide Mononitrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62135-586
Application NumberANDA075522
Product Classification
M
Marketing Category
C73584
G
Generic Name
Isosorbide Mononitrate
Product Specifications
Route of AdministrationORAL
Effective DateMay 2, 2023
FDA Product Classification
INGREDIENTS (6)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ISOSORBIDE MONONITRATEActive
Quantity: 30 mg in 1 1
Code: LX1OH63030
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Isosorbide Mononitrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62135-587
Application NumberANDA075522
Product Classification
M
Marketing Category
C73584
G
Generic Name
Isosorbide Mononitrate
Product Specifications
Route of AdministrationORAL
Effective DateMay 2, 2023
FDA Product Classification
INGREDIENTS (7)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
ISOSORBIDE MONONITRATEActive
Quantity: 60 mg in 1 1
Code: LX1OH63030
Classification: ACTIB