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 Initial U.S. Approval: 1981
Approved
Approval ID
5a36dac2-7d35-4cbf-be3d-705b7135754d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 27, 2023
Manufacturers
FDA
Advagen Pharma Ltd
DUNS: 051627256
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 Code72888-139
Application NumberANDA209779
Product Classification
M
Marketing Category
C73584
G
Generic Name
nitroglycerin
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateSeptember 27, 2023
FDA Product Classification
INGREDIENTS (6)
GLYCERYL BEHENATE/EICOSADIOATEInactive
Code: 73CJJ317SR
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
NITROGLYCERINActive
Quantity: 0.4 mg in 1 1
Code: G59M7S0WS3
Classification: ACTIB
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
nitroglycerin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72888-140
Application NumberANDA209779
Product Classification
M
Marketing Category
C73584
G
Generic Name
nitroglycerin
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateSeptember 27, 2023
FDA Product Classification
INGREDIENTS (6)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
GLYCERYL BEHENATE/EICOSADIOATEInactive
Code: 73CJJ317SR
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
NITROGLYCERINActive
Quantity: 0.6 mg in 1 1
Code: G59M7S0WS3
Classification: ACTIB
nitroglycerin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72888-138
Application NumberANDA209779
Product Classification
M
Marketing Category
C73584
G
Generic Name
nitroglycerin
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateSeptember 27, 2023
FDA Product Classification
INGREDIENTS (6)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
GLYCERYL BEHENATE/EICOSADIOATEInactive
Code: 73CJJ317SR
Classification: IACT
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
NITROGLYCERINActive
Quantity: 0.3 mg in 1 1
Code: G59M7S0WS3
Classification: ACTIB
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT