Sterile Water for Injection, USP in Flexible Plastic ContainerFor Drug Diluent Use OnlyRx only

Sterile Water by

Drug Labeling and Warnings

Sterile Water by is a Prescription medication manufactured, distributed, or labeled by Hikma Farmaceutica, Hikma Pharmaceuticals USA Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

STERILE WATER- sterile water injection, solution 
Hikma Farmaceutica

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Sterile Water for Injection, USP
in Flexible Plastic Container
For Drug Diluent Use Only
Rx only

ADVERSE REACTIONS

The administration of a suitable admixture of prescribed additives may be associated with adverse reactions because of the solution or the technique of administration including febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation, and hypervolemia.

If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures, and save the remainder of the fluid for examination if deemed necessary.

To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

For Product Inquiry call 1-877-845-0689.

PRINCIPAL DISPLAY PANEL

Sterile Water for Injection, USP inner bag

Inner bag

PRINCIPAL DISPLAY PANEL

Sterile Water  for Injection, USP overwrap

overwrap
STERILE WATER 
sterile water injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 62778-347
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER1 mL  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 62778-347-4112 in 1 CASE05/05/202305/05/2023
11000 mL in 1 BAG; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21273505/05/202305/05/2023
Labeler - Hikma Farmaceutica (452742943)

Revised: 2/2024
 

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