NITROLINGUAL (Page 4 of 4)

PRINCIPAL DISPLAY PANEL
Nitrolingual
Pumpspray
Rx Only
400 Mcg per spray
200 Metered Sprays14.1 g Net Contents

image description
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PRINCIPAL DISPLAY PANEL
Nitrolingual
Pumpspray
Rx Only
400 Mcg per spray
60 Metered Sprays4.9 g Net Contents

image description
(click image for full-size original)
NITROLINGUAL nitroglycerin spray
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70007-300
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NITROGLYCERIN (NITROGLYCERIN) NITROGLYCERIN 400 ug
Inactive Ingredients
Ingredient Name Strength
MEDIUM-CHAIN TRIGLYCERIDES
ALCOHOL
PEPPERMINT OIL
SODIUM LACTATE
LACTIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70007-300-65 1 BOTTLE, SPRAY in 1 CARTON contains a BOTTLE, SPRAY
1 60 SPRAY in 1 BOTTLE, SPRAY This package is contained within the CARTON (70007-300-65)
2 NDC:70007-300-20 1 BOTTLE, SPRAY in 1 CARTON contains a BOTTLE, SPRAY
2 200 SPRAY in 1 BOTTLE, SPRAY This package is contained within the CARTON (70007-300-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018705 03/01/2016
Labeler — Espero Pharmaceuticals, Inc. (079905661)

Revised: 08/2018 Espero Pharmaceuticals, Inc.

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