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
8b0c1500-430a-45dd-a316-5da5ccde2514
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 2, 2023
Manufacturers
FDA
REMEDYREPACK INC.
DUNS: 829572556
Products 1
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 Code70518-3596
Application NumberANDA211604
Product Classification
M
Marketing Category
C73584
G
Generic Name
NITROGLYCERIN
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateAugust 2, 2023
FDA Product Classification
INGREDIENTS (6)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
NITROGLYCERINActive
Quantity: 0.4 mg in 1 1
Code: G59M7S0WS3
Classification: ACTIB
SILICA DIMETHYL SILYLATEInactive
Code: EU2PSP0G0W
Classification: IACT
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT