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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

fa789d65-9407-4965-bd06-4457444b42be

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 21, 2021

Manufacturers
FDA

Glenmark Pharmaceuticals Inc., USA

DUNS: 130597813

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 Code68462-640
Application NumberANDA206391
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nitroglycerin
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateOctober 21, 2021
FDA Product Classification

INGREDIENTS (5)

LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
NITROGLYCERINActive
Quantity: 0.6 mg in 1 1
Code: G59M7S0WS3
Classification: ACTIB
SILICA DIMETHYL SILYLATEInactive
Code: EU2PSP0G0W
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT

Nitroglycerin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code68462-638
Application NumberANDA206391
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nitroglycerin
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateOctober 21, 2021
FDA Product Classification

INGREDIENTS (5)

CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SILICA DIMETHYL SILYLATEInactive
Code: EU2PSP0G0W
Classification: IACT
NITROGLYCERINActive
Quantity: 0.3 mg in 1 1
Code: G59M7S0WS3
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT

Nitroglycerin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code68462-639
Application NumberANDA206391
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nitroglycerin
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateOctober 21, 2021
FDA Product Classification

INGREDIENTS (5)

NITROGLYCERINActive
Quantity: 0.4 mg in 1 1
Code: G59M7S0WS3
Classification: ACTIB
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
SILICA DIMETHYL SILYLATEInactive
Code: EU2PSP0G0W
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT

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Nitroglycerin - FDA Drug Approval Details