Nitroglycerin
Approved
Approval ID
33574801-581a-4028-befd-8e0cc8b6a892
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 30, 2009
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-6045
Application NumberNDA021134
Product Classification
M
Marketing Category
C73605
G
Generic Name
Nitroglycerin
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateSeptember 30, 2009
FDA Product Classification
INGREDIENTS (5)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
NITROGLYCERINActive
Quantity: 0.4 mg in 1 1
Code: G59M7S0WS3
Classification: ACTIB