Sterile Water (Page 2 of 2)

Serialization Label — 20 mL

Serialization Label -- 20 mL
(click image for full-size original)
STERILE WATER water injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0517-3005
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
WATER (WATER) WATER 1 mL in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0517-3005-25 25 VIAL, SINGLE-DOSE in 1 TRAY contains a VIAL, SINGLE-DOSE (0517-3005-01)
1 NDC:0517-3005-01 5 mL in 1 VIAL, SINGLE-DOSE This package is contained within the TRAY (0517-3005-25)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 09/30/1990
STERILE WATER water injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0517-3010
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
WATER (WATER) WATER 1 mL in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0517-3010-25 25 VIAL, SINGLE-DOSE in 1 TRAY contains a VIAL, SINGLE-DOSE (0517-3010-01)
1 NDC:0517-3010-01 10 mL in 1 VIAL, SINGLE-DOSE This package is contained within the TRAY (0517-3010-25)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 01/25/1999
STERILE WATER water injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0517-3020
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
WATER (WATER) WATER 1 mL in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0517-3020-25 25 VIAL, SINGLE-DOSE in 1 TRAY contains a VIAL, SINGLE-DOSE (0517-3020-01)
1 NDC:0517-3020-01 20 mL in 1 VIAL, SINGLE-DOSE This package is contained within the TRAY (0517-3020-25)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 09/03/1996
Labeler — American Regent, Inc. (002033710)
Establishment
Name Address ID/FEI Operations
American Regent, Inc. 002033710 ANALYSIS (0517-3005), ANALYSIS (0517-3010), ANALYSIS (0517-3020), MANUFACTURE (0517-3005), MANUFACTURE (0517-3010), MANUFACTURE (0517-3020), STERILIZE (0517-3005), STERILIZE (0517-3010), STERILIZE (0517-3020)

Revised: 03/2019 American Regent, Inc.

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