Heparin Sodium: Package Insert and Label Information (Page 3 of 3)

PRINCIPAL DISPLAY PANEL — 250 mL Bag Overwrap — 7651

2 HDPE

TO OPEN TEAR AT NOTCH

DO NOT REMOVE FROM OVERWRAP UNTIL READY FOR USE. AFTER REMOVING
THE OVERWRAP, CHECK FOR MINUTE LEAKS BY SQUEEZING CONTAINER FIRMLY.
IF LEAKS ARE FOUND, DISCARD SOLUTION AS STERILITY MAY BE IMPAIRED.
RECOMMENDED STORAGE: ROOM TEMPERATURE (25°C). AVOID EXCESSIVEHEAT. PROTECT FROM FREEZING. SEE INSERT.

98-4321-R14-3/98

PRINCIPAL DISPLAY PANEL -- 250 mL Bag Overwrap -- 7651
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 500 mL Bag Label

500 mL
25,000 USP Units / 500 mL
(50 USP Units / mL)
NDC 0409-7651-13

Heparin Sodium in
0.45% Sodium Chloride Injection

EACH 100 mL CONTAINS HEPARIN SODIUM 5,000 USP
UNITS (PORCINE INTESTINAL MUCOSA); SODIUM
CHLORIDE 0.45 g; EDETATE DISODIUM, ANHYDROUS
10 mg ADDED AS STABILIZER. MAY CONTAIN SODIUM
HYDROXIDE AND/OR HYDROCHLORIC ACID FOR
pH ADJUSTMENT. STERILE. NOT MADE WITH NATURAL
RUBBER LATEX. USUAL DOSAGE: SEE INSERT.

ADDITIVES SHOULD NOT BE MADE TO THIS SOLUTION.

SINGLE DOSE CONTAINER. DISCARD UNUSED PORTION.
FOR INTRAVENOUS USE ONLY.

Rx ONLY

3
VCONTAINS DEHP

IM-3958

HOSPIRA, INC., LAKE FOREST, IL 60045 USA

Hospira

PRINCIPAL DISPLAY PANEL -- 500 mL Bag Label -- 7651
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 500 mL Bag Overwrap

2 HDPE

TO OPEN TEAR AT NOTCH

DO NOT REMOVE FROM OVERWRAP UNTIL READY FOR USE. AFTER REMOVING
THE OVERWRAP, CHECK FOR MINUTE LEAKS BY SQUEEZING CONTAINER FIRMLY.
IF LEAKS ARE FOUND, DISCARD SOLUTION AS STERILITY MAY BE IMPAIRED.
RECOMMENDED STORAGE: ROOM TEMPERATURE (25°C). AVOID EXCESSIVEHEAT. PROTECT FROM FREEZING. SEE INSERT.

98-4321-R14-3/98

PRINCIPAL DISPLAY PANEL -- 500 mL Bag Overwrap
(click image for full-size original)
HEPARIN SODIUM heparin sodium injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-7650
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HEPARIN SODIUM (HEPARIN) HEPARIN 10000 [USP'U] in 100 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 0.45 g in 100 mL
EDETATE DISODIUM ANHYDROUS 10 mg in 100 mL
SODIUM HYDROXIDE
HYDROCHLORIC ACID
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0409-7650-62 24 POUCH in 1 CASE contains a POUCH
1 1 BAG in 1 POUCH This package is contained within the CASE (0409-7650-62) and contains a BAG (0409-7650-52)
1 NDC:0409-7650-52 250 mL in 1 BAG This package is contained within a POUCH and a CASE (0409-7650-62)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018916 06/30/2005
HEPARIN SODIUM heparin sodium injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0409-7651
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HEPARIN SODIUM (HEPARIN) HEPARIN 5000 [USP'U] in 100 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 0.45 g in 100 mL
EDETATE DISODIUM ANHYDROUS 10 mg in 100 mL
SODIUM HYDROXIDE
HYDROCHLORIC ACID
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0409-7651-62 24 POUCH in 1 CASE contains a POUCH
1 1 BAG in 1 POUCH This package is contained within the CASE (0409-7651-62) and contains a BAG (0409-7651-52)
1 NDC:0409-7651-52 250 mL in 1 BAG This package is contained within a POUCH and a CASE (0409-7651-62)
2 NDC:0409-7651-03 24 POUCH in 1 CASE contains a POUCH
2 1 BAG in 1 POUCH This package is contained within the CASE (0409-7651-03) and contains a BAG (0409-7651-13)
2 NDC:0409-7651-13 500 mL in 1 BAG This package is contained within a POUCH and a CASE (0409-7651-03)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018916 06/21/2005
Labeler — Hospira, Inc. (141588017)
Establishment
Name Address ID/FEI Operations
Hospira, Inc. 827731089 ANALYSIS (0409-7650), ANALYSIS (0409-7651)
Establishment
Name Address ID/FEI Operations
Hospira, Inc. 093132819 ANALYSIS (0409-7650), ANALYSIS (0409-7651), LABEL (0409-7650), LABEL (0409-7651), MANUFACTURE (0409-7650), MANUFACTURE (0409-7651), PACK (0409-7650), PACK (0409-7651)
Establishment
Name Address ID/FEI Operations
Hospira, Inc. 030606222 ANALYSIS (0409-7650), ANALYSIS (0409-7651)

Revised: 11/2019 Hospira, Inc.

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