Oxaliplatin (Page 10 of 10)

PRINCIPAL DISPLAY PANEL — 10 mL Vial Label

10 mL Single Dose Vial
NDC 61703-363-18

Sterile Aqueous Solution

Oxaliplatin Injection, USP

Rx only

50 mg/ 10 mL

(5 mg/mL)

For Intravenous Use Only
See package insert for further required dilution
Do not dilute with sodium chloride/
chloride-containing solutions Caution: Cytotoxic Agent

Hospira

PRINCIPAL DISPLAY PANEL -- 10 mL Vial Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 10 mL Vial Carton

VIAL

Hospira

1 x 10 mL Vial
NDC 61703-363-18

Sterile Aqueous Solution

Oxaliplatin
Injection, USP

50 mg/ 10 mL

(5 mg/mL)

Rx only

For Intravenous Use Only

See package insert for
further required dilution

Do not dilute with sodium chloride/chloride-containing solutions

Single Dose Vial

Caution: Cytotoxic Agent

PRINCIPAL DISPLAY PANEL -- 10 mL Vial Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 20 mL Vial Label

20 mL Single Dose Vial
NDC 61703-363-22

Sterile Aqueous Solution

Oxaliplatin Injection, USP

Rx only

100 mg/ 20 mL

(5 mg/mL)

For Intravenous Use Only
See package insert for further required dilution
Do not dilute with sodium chloride/
chloride-containing solutions Caution: Cytotoxic Agent

Hospira

PRINCIPAL DISPLAY PANEL -- 20 mL Vial Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 20 mL Vial Carton

VIAL

Hospira

1 x 20 mL Vial
NDC 61703-363-22

Sterile Aqueous Solution

Oxaliplatin
Injection, USP

100 mg/ 20 mL

(5 mg/mL)

Rx only

For Intravenous Use Only

See package insert for
further required dilution

Do not dilute with sodium chloride/chloride-containing solutions

Single Dose Vial

Caution: Cytotoxic Agent

PRINCIPAL DISPLAY PANEL -- 20 mL Vial Carton
(click image for full-size original)
OXALIPLATIN oxaliplatin injection, solution, concentrate
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61703-363
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXALIPLATIN (OXALIPLATIN) OXALIPLATIN 5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
TARTARIC ACID 0.03 mg in 1 mL
SODIUM HYDROXIDE 0.0123 mg in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61703-363-18 1 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE
1 10 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (61703-363-18)
2 NDC:61703-363-22 1 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE
2 20 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (61703-363-22)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078813 08/10/2009
Labeler — Hospira, Inc. (141588017)
Establishment
Name Address ID/FEI Operations
Hospira Australia Pty Ltd 758967652 ANALYSIS (61703-363), MANUFACTURE (61703-363), PACK (61703-363), LABEL (61703-363)
Establishment
Name Address ID/FEI Operations
Zydus Hospira Oncology Private Limited 676190889 ANALYSIS (61703-363), MANUFACTURE (61703-363), PACK (61703-363), LABEL (61703-363)

Revised: 09/2023 Hospira, Inc.

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