Nitrostat
These highlights do not include all the information needed to use NITROSTAT safely and effectively. See full prescribing information for NITROSTAT NITROSTAT (nitroglycerin) sublingual tablet Initial U.S. Approval: 1981
Approved
Approval ID
cc481829-0b5a-4e8a-ab5b-cb44d6d2433b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 1, 2019
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
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 Code50090-0133
Application NumberNDA021134
Product Classification
M
Marketing Category
C73594
G
Generic Name
nitroglycerin
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateFebruary 28, 2018
FDA Product Classification
INGREDIENTS (6)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
NITROGLYCERINActive
Quantity: 0.4 mg in 1 1
Code: G59M7S0WS3
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT