Desmopressin Acetate (Page 3 of )

DESMOPRESSIN ACETATE — desmopressin acetate spray
Zydus Lifesciences Limited

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1314-1

Desmopressin Acetate Nasal Solution (Nasal Spray), 10 mcg/ 0.1 mL per spray

5 mL

Rx only

Image
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DESMOPRESSIN ACETATE
desmopressin acetate spray
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1314
Route of Administration NASAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DESMOPRESSIN ACETATE (DESMOPRESSIN) DESMOPRESSIN ACETATE 0.1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
CITRIC ACID MONOHYDRATE
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE
BENZALKONIUM CHLORIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1314-1 5 mL in 1 BOTTLE, SPRAY None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091345 02/01/2018
Labeler — Zydus Lifesciences Limited (918596198)
Registrant — Zydus Lifesciences Limited (918596198)
Establishment
Name Address ID/FEI Operations
Zydus Lifesciences Limited 918596198 ANALYSIS (70771-1314), MANUFACTURE (70771-1314)

Revised: 10/2022 Zydus Lifesciences Limited

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