NDC Code(s) : 24338-300-65, 24338-300-66, 24338-300-20
Packager : Arbor Pharmaceuticals, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Nitrolingual Pumpspraynitroglycerin SPRAY, METERED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24338-300
Route of Administration ORAL 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
medium-chain triglycerides(UNII: C9H2L21V7U)
alcohol(UNII: 3K9958V90M)
peppermint oil(UNII: AV092KU4JH)
sodium lactate(UNII: TU7HW0W0QT)
lactic acid, unspecified form(UNII: 33X04XA5AT)
Product Characteristics
Color Score
Shape Size
Flavor PEPPERMINT Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:24338-300-651 in 1 CARTON 01/02/2000
160 in 1 BOTTLE Type 0: Not a Combination Product
2NDC:24338-300-661 in 1 CARTON 01/02/2000
260 in 1 BOTTLE Type 0: Not a Combination Product
3NDC:24338-300-201 in 1 CARTON 01/02/2000
3200 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 NDA018705 02/01/2000 10/31/2017

PRINCIPAL DISPLAY PANEL

Nitrolingual ®
Pumpspray

(nitroglycerin
lingual spray)

400 mcg per spray
60 Metered Sprays
4.9 g Net Contents

DO NOT SHAKE
HOLD CONTAINER UPRIGHT
PRIME BEFORE USE

NDC 24338-300-65

arbor
PHARMACEUTICALS, INC.

PRINCIPAL DISPLAY PANEL - 4.9 g Spray Bottle Carton