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 TABLETSNITROGLYCERIN sublingual tablets, for oral useInitial U.S. Approval: 1981
Approved
Approval ID
38059df3-be1b-4226-9f12-c3c37cb44fea
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 5, 2023
Manufacturers
FDA
Lifestar Pharma LLC
DUNS: 080268943
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 Code70756-013
Application NumberANDA217970
Product Classification
M
Marketing Category
C73584
G
Generic Name
nitroglycerin
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateDecember 5, 2023
FDA Product Classification
INGREDIENTS (6)
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
NITROGLYCERINActive
Quantity: 0.3 mg in 1 1
Code: G59M7S0WS3
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYDROGENATED COTTONSEED OILInactive
Code: Z82Y2C65EA
Classification: IACT
nitroglycerin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70756-016
Application NumberANDA217970
Product Classification
M
Marketing Category
C73584
G
Generic Name
nitroglycerin
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateDecember 5, 2023
FDA Product Classification
INGREDIENTS (6)
NITROGLYCERINActive
Quantity: 0.6 mg in 1 1
Code: G59M7S0WS3
Classification: ACTIB
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYDROGENATED COTTONSEED OILInactive
Code: Z82Y2C65EA
Classification: IACT
nitroglycerin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70756-014
Application NumberANDA217970
Product Classification
M
Marketing Category
C73584
G
Generic Name
nitroglycerin
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateDecember 5, 2023
FDA Product Classification
INGREDIENTS (6)
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
NITROGLYCERINActive
Quantity: 0.4 mg in 1 1
Code: G59M7S0WS3
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYDROGENATED COTTONSEED OILInactive
Code: Z82Y2C65EA
Classification: IACT