NDC Code(s) : 24090-410-08, 24090-410-04, 24090-410-99, 24090-410-07, 24090-410-03
Packager : Akrimax Pharmaceuticals, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

NitroMistnitroglycerin AEROSOL, METERED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24090-410
Route of Administration SUBLINGUAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NITROGLYCERIN(UNII: G59M7S0WS3)
(NITROGLYCERIN - UNII:G59M7S0WS3) 		NITROGLYCERIN400 ug
Inactive Ingredients
Ingredient Name Strength
CAPRYLIC/CAPRIC/SUCCINIC TRIGLYCERIDE(UNII: J4BY50FL78)
PEPPERMINT OIL(UNII: AV092KU4JH)
MENTHOL(UNII: L7T10EIP3A)
BUTANE(UNII: 6LV4FOR43R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:24090-410-081 in 1 CARTON 01/05/2010
1230 in 1 BOTTLE Type 0: Not a Combination Product
2NDC:24090-410-041 in 1 CARTON 01/05/2010
290 in 1 BOTTLE Type 0: Not a Combination Product
3NDC:24090-410-991 in 1 CARTON 01/05/2010
3230 in 1 BOTTLE Type 0: Not a Combination Product
4NDC:24090-410-071 in 1 CARTON 01/05/2010
4200 in 1 BOTTLE Type 0: Not a Combination Product
5NDC:24090-410-031 in 1 CARTON 01/05/2010
560 in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021780 05/01/2010 05/31/2018

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL
NDC-24090-410-08
NITROMIST ®
(Nitroglycerin) Lingual Aerosol
400 mcg/spray
Rx Only
Contains approximately 230 sprays
for use on or under the tongue

NDC-24090-410-08 NITROMIST® (Nitroglycerin) Lingual Aerosol 400 mcg/spray Rx Only Contains approximately 230 sprays for use on or under the tongue