NDC 0264-9999 Sodium Chloride
Product Information
What is NDC 0264-9999?
The NDC code 0264-9999 is assigned by the FDA to the product Sodium Chloride which is product labeled by B. Braun Medical Inc.. The product's dosage form is and is administered via form. The product is distributed in 2 packages with assigned NDC codes 0264-9999-00 10 container in 1 case / 1000 ml in 1 container, 0264-9999-10 10 container in 1 case / 500 ml in 1 container. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.
What are the uses for Sodium Chloride?
This solution is used to supply water and salt (sodium chloride) to the body. Sodium chloride solution may also be mixed with other medications given by injection into a vein.
Product Packages
NDC Code 0264-9999-00
Package Description: 10 CONTAINER in 1 CASE / 1000 mL in 1 CONTAINER
NDC Code 0264-9999-10
Package Description: 10 CONTAINER in 1 CASE / 500 mL in 1 CONTAINER
Product Details
Sodium Chloride Active Ingredients UNII Codes
- SODIUM CHLORIDE (UNII: 451W47IQ8X)
- SODIUM CATION (UNII: LYR4M0NH37) (Active Moiety)
- CHLORIDE ION (UNII: Q32ZN48698) (Active Moiety)
NDC to RxNorm Crosswalk
- RxCUI: 1807639 - sodium chloride 0.9 % in 1000 ML Injection
- RxCUI: 1807639 - 1000 ML sodium chloride 9 MG/ML Injection
- RxCUI: 1807639 - 1000 ML NaCl 9 MG/ML Injection
- RxCUI: 1807639 - sodium chloride 0.9 % per 1000 ML Injection
Sodium Chloride Inactive Ingredients UNII Codes
- WATER (UNII: 059QF0KO0R)
* Please review the disclaimer below.
Sodium Chloride Product Label
FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Product Label Table of Contents
Important Prescribing Information
B. Braun Medical Inc.
824 12th Avenue
Bethlehem, PA 18018
610-691-5400
October 20, 2017
Subject: Temporary Importation of 0.9% Sodium Chloride w/v Intravenous Infusion in Ecoflac Plus Containers
Dear Health Care Provider,
The purpose of this letter is to inform you of an additional foreign product that B. Braun Medical Inc. (B. Braun) will be providing in the United States (U.S.) to address the critical drug shortage of 0.9% Sodium Chloride for Injection. Due to the shortage of 0.9% Sodium Chloride Injection products in the U.S., B. Braun is coordinating with the U.S. Food and Drug Administration (FDA) to temporarily import foreign Sodium Chloride 0.9% w/v Intravenous Infusion BP in the Ecoflac plus container into the U.S. market. The foreign product is manufactured at an FDA inspected B. Braun sterile injectable facility in Melsungen, Germany which is currently in compliance with FDA regulations.
At this time, no other entity except B. Braun is authorized by the FDA to import or directly/indirectly distribute Sodium Chloride 0.9% w/v Intravenous Infusion BP in the Ecoflac® plus container in the U.S. FDA has not approved B. Braun’s Sodium Chloride 0.9% w/v Intravenous Infusion BP in the Ecoflac plus container in the United States.
Effective immediately and during this temporary period, B. Braun will offer the following presentations of B. Braun’s Sodium Chloride 0.9% w/v Intravenous Infusion BP in the Ecoflac plus container:
Product Name | Volume | Ingredients |
Sodium Chloride 0.9% w/v Intravenous Infusion BP in the Ecoflac plus container | 1,000 mL | Each 1,000 mL contains: Sodium Chloride 9.0 g, Water for Injections to 1,000 mL Electrolytes per 1,000 mL is Sodium 154 mmol, Chloride 154 mmol |
Ecoflac plus container- Not made with natural rubber latex, PVC, or DEHP.
Indications and Usage and Dosage Administration
The foreign unapproved product, packaged in a semi-rigid Ecoflac® (polyethylene plastic) container, contains the same active ingredient in the same concentration as the 0.9% Sodium Chloride Injection products approved in the U. S., packaged in the flexible plastic EXCEL® (ethylene-propylene copolymer) bag. As such, clinical practice pertaining to indication, usage and dosage administration for Sodium Chloride 0.9% w/v Intravenous Infusion BP in the Ecoflac® plus container is the same as with the EXCEL® containers.
However, some key differences between the Ecoflac and EXCEL® container packaging and labeling are described below in the Product Comparison Table.
It is also important to note that the Ecoflac plus container is a semi rigid plastic bottle. However, no venting is necessary during infusion. Ecoflac® plus collapses completely when emptying.
Ecoflac plus container and carton labeling may include barcodes that may not register accurately in the U.S. scanning systems. Institutions should manually input the product into their systems and confirm that barcode systems do not provide incorrect information when the product is scanned. Alternative procedures should be followed to assure that the correct drug product is being used and administered to individual patients.
Reporting Adverse Events
To report adverse events or quality problems with B. Braun’s Sodium Chloride 0.9% w/v Intravenous Infusion BP in the Ecoflac® plus container, please contact the B. Braun Clinical and Technical Support Department at 1-800-854-6851. Adverse events that may be related to the use of this product may also be reported to the FDA's MedWatch Adverse Event Reporting program either online, or regular mail or by fax:
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Thank you for your commitment to B. Braun’s IV solution products.
Tom Sutton
Vice President of Marketing
PRODUCT COMPARISON TABLE | ||
Item | German Product – Ecoflac® Container | US Product - EXCEL® Container |
Product Drawing |
Ecoflac® Plus |
EXCEL® |
Product Description | 0.9% w/v Sodium Chloride BP | 0.9% Sodium Chloride Injection USP |
Product Code | 9999-00 | L8000 |
Unit Bar Code | No | Yes (NDC and Lot/Exp) |
NDC # | 0264-9999-00 | 0264-7800-00 |
Volume | 1,000 mL | 1,000 mL |
Case Quantity | 10 units per case | 12 units per case |
Storage Condition | Do not store above 25°C | Store at room temperature (25°C) |
Shelf Life | 36 months | 30 months |
Ingredients | Each 1,000 mL contains: Sodium Chloride EP 900 mg, Water for Injection EP to 1,000 mL Total Electrolytes per 1,000 mL : Sodium 154 mEq, Chloride 154 mEq | Each 1,000 mL contains: Sodium Chloride USP 900 mg, Water for Injection USP to 1,000 mL. Total Electrolytes per 1,000 mL: Sodium 154 mEq, Chloride 154 mEq |
Container Type | Ecoflac® Plus, Polyethylene Plastic Containers (semi rigid plastic bottle) | Excel®, Primary plastic container with a clear overwrap (flexible plastic bag) |
Container material | Low Density Polyethylene (LDPE) | Copolymer of ethylene and propylene |
Container Description | Blow/Fill/Seal (BFS) | Form/Fill/Seal (FFS) |
PVC, DEHP, Latex | No | No |
Overwrap | No | Yes |
Closure Description | Twin cap with peel tab cover | Additive port with elastomeric stopper, Administration port with plastic cover |
Pictures of Difference in Container Port System |
Twin Port with peel tab cover and two interchangeable access ports with thermoplastic elastomeric septum |
Separate additive and administration ports |
Additive Port Material | Thermoplastic elastomer | Synthetic Isoprene |
Needle Size | 18-21 gauge | 18-22 gauge |
Additive Volume | 170 mL | 200 mL |
Spike Port Resealable | Yes | No |
Pressure Infusion | No | Yes, not to exceed 300mm Hg |
Sterilization Process | Terminal Steam Sterilization Sterility Test (Ph. Eur.) Sterility Assurance Level of 10-6 | Terminal Steam Sterilization Parametric Release Sterility Assurance Level of 10-6 |
Principal Display Panel
Sodium Chloride 0.9% w/v
Intravenous Infusion BP
Expel all air before pressure infusion.
This 1000 ml contains:
Electrolytes mmol
Sodium 154
Chloride 154
Sodium Chloride 9.0 g
Water for injections
pH 4.5 - 7.0
Solution for infusion. For intravenous use only. Use as directed by a medical practitioner. Do not use if container or closure is damaged. For single use only. Do not reconnect partially used containers.
Contents: 1000 ml
Discard any unused contents. Solutions containing visible solid particles should not be administered. Keep out of the reach and sight of children. Do not store above 25 °C. In case of an adverse reaction, infusion must be stopped immediately. No other medication or substance should be added to this fluid unless the compatibility is known. Thorough and careful mixing of any additive is mandatory. For further information, see enclosed package leaflet.
LOT
EXP:
B. Braun Melsungen AG
D-34209 Melsungen
Germany
5/12625007/1117
* Please review the disclaimer below.