NICOTROL
Nicotrol Inhaler (nicotine inhalation system) 10 mg per cartridge (4 mg delivered)
Approved
Approval ID
f32f9c92-cbb4-483b-9e70-0b6e4567824f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 10, 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.
nicotine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5052
Application NumberNDA020714
Product Classification
M
Marketing Category
C73594
G
Generic Name
nicotine
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateMay 5, 2011
FDA Product Classification
INGREDIENTS (2)
NICOTINEActive
Quantity: 4 mg in 1 1
Code: 6M3C89ZY6R
Classification: ACTIB
MENTHOLInactive
Code: L7T10EIP3A
Classification: IACT