Desmopressin Acetate (Page 3 of 3)

HOW SUPPLIED

Desmopressin acetate injection, USP 4 mcg/mL is available as a sterile solution in 10 mL multiple-dose vials (NDC 16714-015-01), each containing 4 mcg desmopressin acetate, USP per mL.
Store refrigerated 2° to 8°C (36° to 46°F). Preserve in tight containers, protected from light.
Keep out of the reach of children.
Manufactured for:
Northstar Rx LLC
Memphis, TN 38141.
Toll No: 1-800-206-7821

Manufactured by:
Sun Pharmaceutical Industries Ltd.
Halol-Baroda Highway,
Halol-389 350, Gujarat, India
Rev. 05/2020
PJPI0660

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rx only
NDC 16714-015-01
Desmopressin Acetate Injection, USP
40 mcg/10 mL
(4 mcg/mL)
FOR INTRAVENOUS/SUBCUTANEOUS USE ONLY
Refrigerate
One 10 mL Multiple-Dose Vial NORTHSTAR

carton1
(click image for full-size original)
DESMOPRESSIN ACETATE desmopressin acetate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-015
Route of Administration INTRAVENOUS, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DESMOPRESSIN ACETATE (DESMOPRESSIN) DESMOPRESSIN ACETATE 4 ug in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
HYDROCHLORIC ACID
CHLOROBUTANOL HEMIHYDRATE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16714-015-01 1 VIAL in 1 CARTON contains a VIAL
1 10 mL in 1 VIAL This package is contained within the CARTON (16714-015-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091280 07/01/2020
Labeler — NorthStar RxLLC (830546433)
Establishment
Name Address ID/FEI Operations
Sun Pharmaceutical Industries Limited 725959238 ANALYSIS (16714-015), MANUFACTURE (16714-015)

Revised: 06/2020 NorthStar RxLLC

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