NITROSTAT
Nitrostat (Nitroglycerin)0.4 mg USP 25 Tablets Bottle
Approved
Approval ID
b32d82ee-7727-4501-a858-a8304135b11b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 12, 2011
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 2
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 Code54868-0691
Application NumberNDA021134
Product Classification
M
Marketing Category
C73594
G
Generic Name
Nitroglycerin
Product Specifications
Route of AdministrationORAL
Effective DateMay 6, 2011
FDA Product Classification
INGREDIENTS (5)
NITROGLYCERINActive
Quantity: 0.4 mg in 1 1
Code: G59M7S0WS3
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
Nitroglycerin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-1538
Application NumberNDA021134
Product Classification
M
Marketing Category
C73594
G
Generic Name
Nitroglycerin
Product Specifications
Route of AdministrationORAL
Effective DateMay 6, 2011
FDA Product Classification
INGREDIENTS (5)
NITROGLYCERINActive
Quantity: 0.3 mg in 1 1
Code: G59M7S0WS3
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT