ISOTONIC SODIUM CHLORIDE

Manufacturer
HAVER FARMA ILAC ANONIM SIRKETI
Effective date
2025-05-05
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 21:32:46

Label at a glance#

ProductISOTONIC SODIUM CHLORIDE
Active ingredientSODIUM CHLORIDE
Label structure2 sections

Label contents#

Full prescribing information#

GENERAL PRECAUTIONS SECTION

ADMINISTERED INTRAVENOUSLY ASEPTICALLY. Do not use if the solution is not clear or the bag is damaged. Please read the package leaflet. Consult your doctor right away if you have any unexpected effect. It is disposable. Partially used solutions should not be stored. Keep out of reach and sight of the children and store in the original package. Store at room temperature below 25°C. Sold with prescription only.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

biofleks
100 mL
0.9 % ISOTONIC
SODIUM CHLORIDE SOLUTION
STERILE

Per 100 mL
Sodium Chloride
Water for Injection

Electrolyte Concentrations (mEq/L)
ADMINISTERED INTRAVENOUSLY ASEPTICALLY. Do not use if the solution is not clear or the bag is damaged. Please read the package leaflet. Consult your doctor right away if you have any unexpected effect. It is disposable. Partially used solutions should not be stored. Keep out of reach and sight of the children and store in the original package. Store at room temperature below 25°C. Sold with prescription only. Distributor: Vin Trading LLC
Phone: (201) 676-3232 / E-Mail: info@vintradingllc.com Address: 203 Lemoine Ave #118, Fort Lee, NJ 07024
OSEL llaç San. ve Tic. A.Ş.
Beykoz / İstanbul / TURKEY

100mL Bag

100 mL100 mL

250mL Bag

250 mL250 mL

500 mL Bag

500 mL500 mL

1000mL Bag

1000 mL1000 mL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1807632sodium chloride 0.9 % in 100 ML InjectionPSN4
1807639sodium chloride 0.9 % in 1000 ML InjectionPSN4
1807633sodium chloride 0.9 % in 250 ML InjectionPSN4
1807634sodium chloride 0.9 % in 500 ML InjectionPSN4
1807632100 ML sodium chloride 9 MG/ML InjectionSCD4
18076391000 ML sodium chloride 9 MG/ML InjectionSCD4
1807633250 ML sodium chloride 9 MG/ML InjectionSCD4
1807634500 ML sodium chloride 9 MG/ML InjectionSCD4
1807632100 ML NaCl 9 MG/ML InjectionSY4
18076391000 ML NaCl 9 MG/ML InjectionSY4
1807633250 ML NaCl 9 MG/ML InjectionSY4
1807634500 ML NaCl 9 MG/ML InjectionSY4
1807632sodium chloride 0.9 % per 100 ML InjectionSY4
1807639sodium chloride 0.9 % per 1000 ML InjectionSY4
1807633sodium chloride 0.9 % per 250 ML InjectionSY4
1807634sodium chloride 0.9 % per 500 ML InjectionSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85184-0001-1ISOTONIC SODIUM CHLORIDE100 mL in 1 BAGINJECTION1004
85184-0001-2ISOTONIC SODIUM CHLORIDE250 mL in 1 BAGINJECTION2504
85184-0001-3ISOTONIC SODIUM CHLORIDE500 mL in 1 BAGINJECTION5004
85184-0001-4ISOTONIC SODIUM CHLORIDE1000 mL in 1 BAGINJECTION10004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85184-0001ISOTONIC SODIUM CHLORIDE (BIOFLEKS ISOTONIC SODIUM CHLORIDE STERILE) INJECTION [HAVER FARMA ILAC ANONIM SIRKETI]44 package rows20250507_2be5b3e2-c4a4-00ea-e063-6394a90a6163.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85184-000185184-0001-1, 85184-0001-2, 85184-0001-3, 85184-0001-4

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM CHLORIDE451W47IQ8XACTIB
WATER059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
3467db24-ab2d-317e-e063-6294a90ab0552be5b3e2-c4a4-00ea-e063-6394a90a61632025-05-05Exact identifier
spl id: 3467db24-ab2d-317e-e063-6294a90ab055
spl set id: 2be5b3e2-c4a4-00ea-e063-6394a90a6163

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.