NDC Code(s) : 0075-2452-01
Packager : sanofi-aventis U.S. LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

DDAVPdesmopressin acetate SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0075-2452
Route of Administration NASAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
desmopressin acetate(UNII: XB13HYU18U)
(desmopressin - UNII:ENR1LLB0FP) 		desmopressin0.1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
sodium chloride(UNII: 451W47IQ8X)7.5 mg in 1 mL
citric acid monohydrate(UNII: 2968PHW8QP)1.7 mg in 1 mL
sodium phosphate, dibasic, dihydrate(UNII: 94255I6E2T)3 mg in 1 mL
Benzalkonium chloride(UNII: F5UM2KM3W7)0.2 mg in 1 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0075-2452-015 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017922 02/21/1978

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

NDC 0075-2452-01

DDAVP®
Nasal Spray
desmopressin acetate

10µg/0.1mL

FOR INTRANASAL
USE ONLY

One 5mL Bottle
(50 Doses)

sanofi aventis

PRINCIPAL DISPLAY PANEL - 5mL Bottle Label

PRINCIPAL DISPLAY PANEL

NDC 0075-2452-01

DDAVP®
Nasal
Spray
desmopressin
acetate

10µg/0.1mL

FOR INTRANASAL USE ONLY

One 5mL Bottle (50 Doses)

sanofi aventis

PRINCIPAL DISPLAY PANEL - 5mL Bottle Carton