ISOTONIC SODIUM CHLORIDE- biofleks isotonic sodium chloride sterile injection 
HAVER FARMA ILAC ANONIM SIRKETI

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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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.

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 mL

250mL Bag

250 mL

500 mL Bag

500 mL

1000mL Bag

1000 mL

ISOTONIC SODIUM CHLORIDE 
biofleks isotonic sodium chloride sterile injection
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:85184-0001
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, IRRIGATION
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE0.9 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:85184-0001-1100 mL in 1 BAG; Type 0: Not a Combination Product01/01/2025
2NDC:85184-0001-2250 mL in 1 BAG; Type 0: Not a Combination Product01/01/2025
3NDC:85184-0001-3500 mL in 1 BAG; Type 0: Not a Combination Product01/01/2025
4NDC:85184-0001-41000 mL in 1 BAG; Type 0: Not a Combination Product01/01/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/01/2025
Labeler - HAVER FARMA ILAC ANONIM SIRKETI (365593526)
Registrant - HAVER FARMA ILAC ANONIM SIRKETI (365593526)
Establishment
NameAddressID/FEIBusiness Operations
HAVER FARMA ILAC ANONIM SIRKETI365593526manufacture(85184-0001)

Revised: 5/2025
Document Id: 3467db24-ab2d-317e-e063-6294a90ab055
Set id: 2be5b3e2-c4a4-00ea-e063-6394a90a6163
Version: 4
Effective Time: 20250505
 
HAVER FARMA ILAC ANONIM SIRKETI