NDC Code(s) : 0075-2450-01
Packager : sanofi-aventis U.S. LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

DDAVP Desmopressin Acetate SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0075-2450
Route of Administration NASAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Desmopressin Acetate(UNII: XB13HYU18U)
(Desmopressin - UNII:ENR1LLB0FP) 		Desmopressin Acetate0.1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
Chlorobutanol(UNII: HM4YQM8WRC)5 mg in 1 mL
sodium chloride(UNII: 451W47IQ8X)9 mg in 1 mL
Hydrochloric acid(UNII: QTT17582CB)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0075-2450-012.5 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017922 02/21/1978

PRINCIPAL DISPLAY PANEL

NDC 0075-2450-01

DDAVP®
Rhinal Tube
desmopressin acetate

10µg/0.1mL

FOR INTRANASAL
USE ONLY

One 2.5mL Bottle

sanofi aventis

PRINCIPAL DISPLAY PANEL - 2.5mL Bottle Label

PRINCIPAL DISPLAY PANEL

NDC 0075-2450-01

DDAVP®
Rhinal
Tube
desmopressin
acetate

10µg/0.1mL

FOR INTRANASAL USE ONLY

One 2.5mL Bottle

sanofi aventis

PRINCIPAL DISPLAY PANEL - 2.5mL Bottle Carton