NDC Code(s) : 0075-2451-01, 0075-2451-53
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:0075-2451
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
desmopressin acetate(UNII: XB13HYU18U)
(desmopressin - UNII:ENR1LLB0FP) 		desmopressin acetate4 ug in 1 mL
Inactive Ingredients
Ingredient Name Strength
sodium chloride(UNII: 451W47IQ8X)9 mg in 1 mL
hydrochloric acid(UNII: QTT17582CB)
chlorobutanol(UNII: HM4YQM8WRC)5 mg in 1 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0075-2451-0110 in 1 CARTON
11 mL in 1 AMPULE
2NDC:0075-2451-531 in 1 CARTON
210 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018938 03/30/1984

PRINCIPAL DISPLAY PANEL

NDC 0075-2451-53

DDAVP®
Injection

desmopressin
acetate

4µg/mL

FOR INJECTION USE ONLY

One 10mL Vial

sanofi aventis

PRINCIPAL DISPLAY PANEL - 4 µg Vial Carton