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NDC 00409-4888-50 Sodium Chloride 9 mg/mL Details
Sodium Chloride 9 mg/mL
Sodium Chloride is a INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Hospira, Inc.. The primary component is SODIUM CHLORIDE.
Product Information
| NDC | 00409-4888 |
|---|---|
| Product ID | 0409-4888_a2e039d7-f931-4356-8ce6-f40241617b2c |
| Associated GPIs | 79750010002018 |
| GCN Sequence Number | 001221 |
| GCN Sequence Number Description | 0.9 % sodium chloride VIAL 0.9 % INJECTION |
| HIC3 | C1B |
| HIC3 Description | SODIUM/SALINE PREPARATIONS |
| GCN | 03034 |
| HICL Sequence Number | 008255 |
| HICL Sequence Number Description | 0.9 % SODIUM CHLORIDE |
| Brand/Generic | Generic |
| Proprietary Name | Sodium Chloride |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Sodium Chloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS |
| Active Ingredient Strength | 9 |
| Active Ingredient Units | mg/mL |
| Substance Name | SODIUM CHLORIDE |
| Labeler Name | Hospira, Inc. |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA018803 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 00409-4888-50 (00409488850)
| NDC Package Code | 0409-4888-50 |
|---|---|
| Billing NDC | 00409488850 |
| Package | 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-4888-50) / 50 mL in 1 VIAL, SINGLE-DOSE (0409-4888-06) |
| Marketing Start Date | 2005-02-28 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 8eb172da-dcd4-4660-4a8f-ad44a14b4af7 Details
SPL UNCLASSIFIED SECTION
DESCRIPTION
This preparation is designed solely for parenteral use only after addition of drugs that require dilution or must be dissolved in an aqueous vehicle prior to injection.
0.9% Sodium Chloride Injection, USP is a sterile, nonpyrogenic, isotonic solution of sodium chloride and water for injection. Each mL contains sodium chloride 9 mg. It contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single-dose containers to dilute or dissolve drugs for injection. 0.308 mOsmol/mL (calc.). 0.9% Sodium Chloride Injection, USP contains no preservatives. The solution may contain hydrochloric acid and/or sodium hydroxide for pH adjustment. pH 5.3 (4.5 to 7.0).
Sodium Chloride, USP is chemically designated NaCl, a white crystalline compound freely soluble in water.
The glass container is a Type I borosilicate glass and meets the requirements of the powdered glass test according to the USP standards.
The semi-rigid vial is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The container requires no vapor barrier to maintain the proper drug concentration.
CLINICAL PHARMACOLOGY
Sodium chloride in water dissociates to provide sodium (Na+) and chloride (Cl‾) ions. These ions are normal constituents of the body fluids (principally extracellular) and are essential for maintaining electrolyte balance.
The distribution and excretion of sodium (Na+) and chloride (Cl‾) are largely under the control of the kidney which maintains a balance between intake and output.
The small volume of fluid and amount of sodium chloride provided by 0.9% Sodium Chloride Injection, USP when used only as an isotonic vehicle for parenteral injection of drugs, is unlikely to exert a significant effect on fluid and electrolyte balance except possibly in neonates and very small infants.
Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult daily requirement ranges from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production).
Water balance is maintained by various regulatory mechanisms. Water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na+) plays a major role in maintaining physiologic equilibrium.
INDICATIONS AND USAGE
PRECAUTIONS
Consult the manufacturer's instructions for choice of vehicle, appropriate dilution or volume for dissolving the drugs to be injected, including the route and rate of injection.
Inspect reconstituted (diluted or dissolved) drugs for clarity (if soluble) and freedom from unexpected precipitation or discoloration prior to administration.
Pregnancy: Animal reproduction studies have not been conducted with 0.9% Sodium Chloride Injection, USP. It is also not known whether sodium chloride injection containing additives can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium chloride injection containing additives should be given to a pregnant woman only if clearly needed.
Pediatric Use: The safety and effectiveness in the pediatric population are based on the similarity of the clinical conditions of the pediatric and adult populations. In neonates or very small infants the volume of fluid may affect fluid and electrolyte balance.
Drug Interactions
Some drugs for injection may be incompatible in a given vehicle, or when combined in the same vehicle or in a vehicle containing benzyl alcohol. Consult with pharmacist, if available.
Use aseptic technique for single or multiple entry and withdrawal from all containers.
When diluting or dissolving drugs, mix thoroughly and use promptly.
Do not store reconstituted solutions of drugs for injection unless otherwise directed by the manufacturer of the solute.
Do not use unless the solution is clear and seal intact. Do not reuse single-dose containers, discard unused portion.
ADVERSE REACTIONS
Reactions which may occur because of this solution, added drugs or the technique of reconstitution or administration include febrile response, local tenderness, abscess, tissue necrosis or infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection and extravasation.
If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate countermeasures, and if possible, retrieve and save the remainder of the unused vehicle for examination.
OVERDOSAGE
Use only as a diluent or solvent. This parenteral preparation is unlikely to pose a threat of carbohydrate, sodium chloride or fluid overload except possibly in neonates or very small infants. In the event these should occur, re-evaluate the patient and institute appropriate corrective measures. See PRECAUTIONS and ADVERSE REACTIONS.
DOSAGE AND ADMINISTRATION
The volume of the preparation to be used for diluting or dissolving any drug for injection, is dependent on the vehicle concentration, dose and route of administration as recommended by the manufacturer. This parenteral should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
HOW SUPPLIED
0.9% Sodium Chloride Injection, USP is supplied in the following:
| Unit of Sale | Concentration |
|---|---|
|
NDC 0409-1918-32
|
0.9% (2 mL) |
|
NDC 0409-1918-33
|
0.9% (3 mL) |
|
NDC 0409-1918-35
|
0.9% (5 mL) |
|
NDC 0409-4888-90
|
0.9% (10 mL) |
|
NDC 0409-4888-10
|
0.9% (10 mL) |
|
NDC 0409-4888-20
|
0.9% (20 mL) |
|
NDC 0409-4888-50
|
0.9% (50 mL) |
|
NDC 0409-4888-12
|
0.9% (10 mL) |
Store at 20 to 25°C (68 to 77°F) [See USP Controlled Room Temperature.]
Instructions for Use of the Syringe Systems
Instructions for using the Carpuject Syringe are available with the reusable Carpuject Holder, List 2049-02.
LIFESHIELD® is the trademark of ICU Medical, Inc. and is used under license.
Distributed by Hospira, Inc., Lake Forest, IL 60045 USA 
LAB-1097-3.0
Revised: 08/2021
PRINCIPAL DISPLAY PANEL - 10 mL Vial Label
PRINCIPAL DISPLAY PANEL - 10 mL Vial Tray
PRINCIPAL DISPLAY PANEL - 20 mL Vial Label
PRINCIPAL DISPLAY PANEL - 20 mL Vial Tray
PRINCIPAL DISPLAY PANEL - 50 mL Vial Label
PRINCIPAL DISPLAY PANEL - 50 mL Vial Tray
PRINCIPAL DISPLAY PANEL - 10 mL Vial Label - LifeShield
PRINCIPAL DISPLAY PANEL - 10 mL Vial Tray - LifeShield
PRINCIPAL DISPLAY PANEL - 2 mL Cartridge Label
PRINCIPAL DISPLAY PANEL - 2 mL Cartridge Container Label
2 mL Single-dose
Preservative-Free
50 Carpuject™ Sterile Cartridge Units
with Luer Lock
Needle not included
NDC 0409-1918-32
Rx only
0.9% Sodium Chloride
Injection, USP
Carpuject Cartridges are to be used ONLY with
Carpuject Holders.
Each CARPUJECT Sterile Cartridge Unit contains 2 mL of a sterile
isotonic solution of Sodium Chloride Injection, USP, 0.9%, and
has a total osmolar concentration of 0.31 mOsmol/mL. Each mL
contains 9 mg of sodium chloride.
Do not use if solution is discolored or contains a precipitate.
Sterile Aqueous Injection.
Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room
Temperature.]
Do not freeze.
PAA116988
LOT #####AA
EXP DMMMYYYY
PRINCIPAL DISPLAY PANEL - 3 mL Cartridge Label
PRINCIPAL DISPLAY PANEL - 3 mL Cartridge Container Label
3 mL Single-dose
Preservative-Free
NDC 0409-1918-33
Rx only
25 Carpuject™ Sterile Cartridge Units
with Luer Lock
Needle not included
0.9% Sodium Chloride
Injection, USP
Carpuject Cartridges are to be used ONLY
with Carpuject Holders.
Each CARPUJECT Sterile Cartridge Unit contains 3 mL of
a sterile isotonic solution of Sodium Chloride Injection,
USP, 0.9%, and has a total osmolar concentration of
0.31 mOsmol/mL. Each mL contains 9 mg of sodium chloride.
Do not use if solution is discolored or contains a precipitate.
Sterile Aqueous Injection.
Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room
Temperature.]
Do not freeze.
PAA116990
LOT #####AA
EXP DMMMYYYY
PRINCIPAL DISPLAY PANEL - 5 mL Cartridge Label
PRINCIPAL DISPLAY PANEL - 5 mL Cartridge Container Label
5 mL Single-dose
Preservative-Free
25 Carpuject™ Sterile Cartridge Units
with Luer Lock
Needle not included
NDC 0409-1918-35
Rx only
0.9% Sodium Chloride
Injection, USP
Carpuject Cartridges are to be used ONLY
with Carpuject Holders.
Each CARPUJECT Sterile Cartridge Unit contains 5 mL of a sterile
isotonic solution of Sodium Chloride Injection, USP, 0.9%, and
has a total osmolar concentration of 0.31 mOsmol/mL. Each mL
contains 9 mg of sodium chloride.
Do not use if solution is discolored or contains a precipitate.
Sterile Aqueous Injection.
Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room
Temperature.]
Do not freeze.
PAA116992
LOT #####AA
EXP DMMMYYYY
INGREDIENTS AND APPEARANCE
| SODIUM CHLORIDE
sodium chloride injection, solution |
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| Labeler - Hospira, Inc. (141588017) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Hospira, Inc. | 093132819 | ANALYSIS(0409-4888) , MANUFACTURE(0409-4888) , PACK(0409-4888) , LABEL(0409-4888) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Hospira, Inc. | 030606222 | ANALYSIS(0409-1918) , MANUFACTURE(0409-1918) , PACK(0409-1918) , LABEL(0409-1918) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Pfizer Healthcare India Private Limited | 860037912 | ANALYSIS(0409-4888) , MANUFACTURE(0409-4888) , PACK(0409-4888) , LABEL(0409-4888) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Sharp Packaging Services, LLC | 143696495 | PACK(0409-4888) | |