Nitrostat
Nitrostat (Nitroglycerin Sublingual Tablets, USP)
Approved
Approval ID
dcb552c1-310a-48af-81ad-a74530531dee
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 16, 2012
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
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 Code21695-450
Application NumberNDA021134
Product Classification
M
Marketing Category
C73594
G
Generic Name
nitroglycerin
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateApril 30, 2010
FDA Product Classification
INGREDIENTS (5)
nitroglycerinActive
Quantity: 0.4 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