NITROGLYCERIN
These highlights do not include all the information needed to use NITROGLYCERIN SUBLINGUAL TABLETS safely and effectively. See full prescribing information for NITROGLYCERIN SUBLINGUAL TABLETS NITROGLYCERIN sublingual tablets, for oral use Initial U.S. Approval: 1981
Approved
Approval ID
26c314ea-077e-490b-826b-2aafcb6e9564
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 1, 2023
Manufacturers
FDA
Aurobindo Pharma Limited
DUNS: 650082092
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
NITROGLYCERIN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59651-658
Application NumberANDA217879
Product Classification
M
Marketing Category
C73584
G
Generic Name
NITROGLYCERIN
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateNovember 1, 2023
FDA Product Classification
INGREDIENTS (8)
NITROGLYCERINActive
Quantity: 0.4 mg in 1 1
Code: G59M7S0WS3
Classification: ACTIB
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SILICA DIMETHYL SILYLATEInactive
Code: EU2PSP0G0W
Classification: IACT
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
NITROGLYCERIN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59651-657
Application NumberANDA217879
Product Classification
M
Marketing Category
C73584
G
Generic Name
NITROGLYCERIN
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateNovember 1, 2023
FDA Product Classification
INGREDIENTS (8)
NITROGLYCERINActive
Quantity: 0.3 mg in 1 1
Code: G59M7S0WS3
Classification: ACTIB
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
SILICA DIMETHYL SILYLATEInactive
Code: EU2PSP0G0W
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
NITROGLYCERIN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59651-659
Application NumberANDA217879
Product Classification
M
Marketing Category
C73584
G
Generic Name
NITROGLYCERIN
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateNovember 1, 2023
FDA Product Classification
INGREDIENTS (8)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICA DIMETHYL SILYLATEInactive
Code: EU2PSP0G0W
Classification: IACT
NITROGLYCERINActive
Quantity: 0.6 mg in 1 1
Code: G59M7S0WS3
Classification: ACTIB
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT