Sodium Bicarbonate: Package Insert and Label Information (Page 2 of 2)

PRINCIPAL DISPLAY PANEL — 50 mL Vial Tray

50 mL Single-dose
25 Units/NDC 0409-6625-02
Rx only

8.4% Sodium Bicarbonate
Injection, USP

50 mEq (1 mEq/mL)
4.2 grams (84 mg/mL)Hospira

PRINCIPAL DISPLAY PANEL -- 50 mL Vial Tray
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 50 mL Syringe Label — 6637

50 mL Single-dose
NDC 0409-6637-34

8.4% SODIUM BICARBONATE
Injection, USP
50 mEq (1 mEq/mL)
Rx only

For I.V. use. Usual dosage: See insert. Sterile, nonpyrogenic.
Discard unused portion.
2 mOsmol/mL (calc.).pH 8.0 (7.0 to 8.5).

RL-0053 (4/04)

PRINCIPAL DISPLAY PANEL -- 50 mL Syringe Label -- 6637
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 50 mL Syringe Carton — 6637

50 mL
NDC 0409-6637-34

8.4% Sodium
Bicarbonate
Injection, USP
50 mEq
(1 mEq/mL)

LifeShield™

Glass
ABBOJECT™
Unit of Use Syringe

with male luer lock
adapter and 18-Gauge
protected needle

Rx only

Hospira◀ PUSH AND PULL TO OPEN

PRINCIPAL DISPLAY PANEL -- 50 mL Syringe Carton -- 6637
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 10 mL Syringe Label — 4900

10 mL Single-dose
NDC 0409-4900-34

PEDIATRIC
8.4% SODIUM BICARBONATE
Inj., USP 10 mEq (1 mEq/mL)

Rx only

Hospira

For I.V. use. Usual dosage: See insert. Sterile,
nonpyrogenic. 2 mOsmol/mL (calc.). pH 8.0 (7.0 to 8.5).

Hospira, Inc., Lake Forest, IL 60045 USARL-0047 (4/04)

PRINCIPAL DISPLAY PANEL -- 10 mL Syringe Label -- 4900
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 10 mL Syringe Carton — 4900

10 mL
NDC 0409-4900-34

PEDIATRIC
8.4% SODIUM
BICARBONATE
INJ., USP
10 mEq (1 mEq/mL)

LifeShield™

Glass
ABBOJECT™
Unit of Use Syringe

with male luer lock
adapter and 20-Gaugeprotected needle

8.4%

Rx only

Hospira

◀ PRESS AND PULL TO OPEN

PRINCIPAL DISPLAY PANEL -- 10 mL Syringe Carton -- 4900
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 50 mL Syringe Label — 4916

50 mL Single-dose
NDC 0409-4916-34

7.5% SODIUM BICARBONATE
Injection, USP
44.6 mEq (0.9 mEq/mL)
Rx only

For I.V. use. Usual dosage: See insert. Sterile, nonpyrogenic. Discard
unused portion.
1.79 mOsmol/mL (calc.).pH 8.0 (7.0 to 8.5)

RL-0056 (4/04)

PRINCIPAL DISPLAY PANEL -- 50 mL Syringe Label -- 4916
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 50 mL Syringe Carton — 4916

50 mL
NDC 0409-4916-34

7.5% SODIUM
BICARBONATE
Inj., USP
44.6 mEq
(0.9 mEq/mL)

LifeShield™

Glass
ABBOJECT®
Unit of Use Syringe

with male luer lock
adapter and 18-Gaugeprotected needle

Rx only

Hospira

◀ PRESS AND PULL TO OPEN

PRINCIPAL DISPLAY PANEL -- 50 mL Syringe Carton -- 4916
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 10 mL Syringe Label — 5534

10 mL Single-dose
NDC 0409-5534-34

4.2% Sodium Bicarbonate Inj., USP

5 mEq/10 mL (0.5 mEq/mL)
Rx only

For intravenous use.
Usual dosage: See insert. Sterile, nonpyrogenic.
0.84 mOsmol/mL. pH 8.0 (7.0 to 8.5).

Hospira, Inc., Lake Forest, IL 60045 USARL — 6947

PRINCIPAL DISPLAY PANEL -- 10 mL Syringe Label -- 5534
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 10 mL Syringe Carton — 5534

10 mL
NDC 0409-5534-34
Rx only

4.2%
Sodium
Bicarbonate
Injection, USP
5 mEq/10 mL (0.5 mEq/mL)

Glass
ABBOJECT®
Unit of Use Syringe
For intravenous use

with male luer lock adapter and20-Gauge protected needle

Hospira

◀ PRESS AND PULL TO OPEN

PRINCIPAL DISPLAY PANEL -- 10 mL Syringe Carton -- 5534
(click image for full-size original)
SODIUM BICARBONATE sodium bicarbonate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-6625
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM BICARBONATE (BICARBONATE ION and SODIUM CATION) SODIUM BICARBONATE 84 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0409-6625-02 25 VIAL in 1 TRAY contains a VIAL
1 50 mL in 1 VIAL This package is contained within the TRAY (0409-6625-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 03/31/2005 03/01/2022
SODIUM BICARBONATE sodium bicarbonate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-6637
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM BICARBONATE (BICARBONATE ION and SODIUM CATION) SODIUM BICARBONATE 84 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0409-6637-34 10 CARTON in 1 PACKAGE contains a CARTON
1 1 SYRINGE in 1 CARTON This package is contained within the PACKAGE (0409-6637-34) and contains a SYRINGE
1 50 mL in 1 SYRINGE This package is contained within a CARTON and a PACKAGE (0409-6637-34)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 01/17/2006 04/01/2022
SODIUM BICARBONATE sodium bicarbonate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-4900
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM BICARBONATE (BICARBONATE ION and SODIUM CATION) SODIUM BICARBONATE 84 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0409-4900-34 10 CARTON in 1 PACKAGE contains a CARTON
1 1 SYRINGE in 1 CARTON This package is contained within the PACKAGE (0409-4900-34) and contains a SYRINGE
1 10 mL in 1 SYRINGE This package is contained within a CARTON and a PACKAGE (0409-4900-34)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 02/21/2006 08/01/2021
SODIUM BICARBONATE sodium bicarbonate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-4916
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM BICARBONATE (BICARBONATE ION and SODIUM CATION) SODIUM BICARBONATE 75 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0409-4916-34 10 CARTON in 1 PACKAGE contains a CARTON
1 1 SYRINGE in 1 CARTON This package is contained within the PACKAGE (0409-4916-34) and contains a SYRINGE
1 50 mL in 1 SYRINGE This package is contained within a CARTON and a PACKAGE (0409-4916-34)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 02/16/2006 02/01/2022
SODIUM BICARBONATE sodium bicarbonate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-5534
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM BICARBONATE (BICARBONATE ION and SODIUM CATION) SODIUM BICARBONATE 42 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0409-5534-34 10 CARTON in 1 PACKAGE contains a CARTON
1 1 SYRINGE in 1 CARTON This package is contained within the PACKAGE (0409-5534-34) and contains a SYRINGE
1 10 mL in 1 SYRINGE This package is contained within a CARTON and a PACKAGE (0409-5534-34)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 12/12/2005 05/01/2022
Labeler — Hospira, Inc. (141588017)
Establishment
Name Address ID/FEI Operations
Hospira, Inc. 093132819 ANALYSIS (0409-4900), ANALYSIS (0409-4916), ANALYSIS (0409-5534), ANALYSIS (0409-6625), ANALYSIS (0409-6637), MANUFACTURE (0409-4900), MANUFACTURE (0409-4916), MANUFACTURE (0409-5534), MANUFACTURE (0409-6625), MANUFACTURE (0409-6637), PACK (0409-4900), PACK (0409-4916), PACK (0409-5534), PACK (0409-6625), PACK (0409-6637), LABEL (0409-4900), LABEL (0409-4916), LABEL (0409-5534), LABEL (0409-6625), LABEL (0409-6637)

Revised: 11/2021 Hospira, Inc.

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