Nitrostat
Nitrostat (Nitroglycerin Sublingual Tablets, USP)
Approved
Approval ID
2d4165c3-169d-5af8-e054-00144ff8d46c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 4, 2019
Manufacturers
FDA
Sina Health Inc
DUNS: 047161553
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 Code70385-2014
Application NumberNDA021134
Product Classification
M
Marketing Category
C73594
G
Generic Name
nitroglycerin
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateFebruary 4, 2019
FDA Product Classification
INGREDIENTS (6)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
NITROGLYCERINActive
Quantity: 0.4 mg in 1 1
Code: G59M7S0WS3
Classification: ACTIB