Bacteriostatic Sodium Chloride (Page 2 of 2)

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45765E

Revised: September 2019

PACKAGE LABEL — PRINCIPAL DISPLAY — Bacteriostatic Sodium Chloride 30 mL Multiple Dose Vial Label

NDC 63323-924-03 924830

Bacteriostatic Sodium Chloride Injection, USP

0.9%

NOT FOR USE IN NEWBORNS

30 mL Multiple Dose Vial

For Drug Diluent Use Only

Not for Inhalation

924830-vial
(click image for full-size original)

PACKAGE LABEL – PRINCIPAL DISPLAY — Bacteriostatic Sodium Chloride 30 mL Multiple Dose Vial Tray Label

NDC 63323-924-30 924830

Bacteriostatic Sodium Chloride Injection, USP

0.9 %

NOT FOR USE IN NEWBORNS

30 mL Multiple Dose Vial

For Drug Diluent Use Only

Not for Inhalation

25 Vials

PACKAGE LABEL – PRINCIPAL DISPLAY -- Bacteriostatic Sodium Chloride 30 mL Multiple Dose Vial Tray Label
(click image for full-size original)
BACTERIOSTATIC SODIUM CHLORIDE
sodium chloride injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63323-924
Route of Administration SUBCUTANEOUS, INTRAVENOUS, INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM CHLORIDE (SODIUM CATION and CHLORIDE ION) SODIUM CHLORIDE 9 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL
HYDROCHLORIC ACID
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63323-924-10 25 VIAL, MULTI-DOSE in 1 TRAY contains a VIAL, MULTI-DOSE (63323-924-01)
1 NDC:63323-924-01 10 mL in 1 VIAL, MULTI-DOSE This package is contained within the TRAY (63323-924-10)
2 NDC:63323-924-30 25 VIAL, MULTI-DOSE in 1 TRAY contains a VIAL, MULTI-DOSE (63323-924-03)
2 NDC:63323-924-03 30 mL in 1 VIAL, MULTI-DOSE This package is contained within the TRAY (63323-924-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA088911 08/08/2000
Labeler — Fresenius Kabi USA, LLC (608775388)
Establishment
Name Address ID/FEI Operations
Fresenius Kabi USA, LLC 840771732 manufacture (63323-924)

Revised: 09/2019 Fresenius Kabi USA, LLC

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