Label: SODIUM CHLORIDE 0.9%- sodium chloride injection, solution

  • NDC Code(s): 85268-806-01, 85268-806-02, 85268-806-03, 85268-806-04, view more
    85268-806-05, 85268-806-06, 85268-806-07, 85268-806-08, 85268-806-09, 85268-806-10
  • Packager: Huaren Pharmaceutical Co., Ltd.
  • Category: HUMAN PRESCRIPTION DRUG LABEL

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.

Drug Label Information

Updated June 2, 2025

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • SODIUM CHLORIDE INJECTION, USP BAG

    Sodium Chloride Injection Instructions

    Please read the instructions carefully and use under the guidance of a physician.

    Check carefully before use. Do not use if leakage is found, the drug liquid is unclear, or there are visible particles, do not use.

  • INGREDIENTS

    This product is an isotonic sterilizing aqueous solution of sodium chloride.

    Chemical Name : Sodium chloride

    Molecular Formula: NaCl

    Molecular Weight: 58.44

    Osmolality: 260~320 mOsmol/kg.

  • CHARACTER

    This product is a colorless and clear liquid.

  • INDICATIONS

    It is used to regulate the balance of water and electrolytes in the body.

  • SPECIFICATION

    50ml: 0.45g; 100ml: 0.9g; 250ml: 2.25g; 500ml: 4.5g; 1000ml: 9g

  • DOSAGE AND USAGE

    Intravenous infusion, dosage according to the need of the disease.

  • ADVERSE REACTIONS

    Excessive and rapid infusion can cause water and sodium retention, edema, elevated blood pressure, rapid heart rate, chest tightness, dyspnea, and even acute left heart failure.

  • PRECAUTIONS

    Use with caution in the following cases:

    1. Edematous diseases, such as nephrotic syndrome, cirrhosis, ascites, congestive heart failure, acute left heart failure, brain edema, and idiopathic edema
    2. Acute renal failure, oliguria stage, chronic renal failure, urine volume decreased, and poor response to diuretic drugs;
    3. Hypertension;
    4. Hypokalemia.

    Follow-up examination:

    1. Serum sodium, potassium, chlorine concentration;
    2. Blood acid-base balance index;
    3. Kidney function;
    4. Blood pressure and cardiopulmonary function.
  • MEDICATION IN PREGNANT WOMEN AND LACTATING WOMEN

    Not clear.

  • MEDICATION IN CHILDREN

    The amount and speed of fluid supplementation should be strictly controlled.

  • MEDICATION IN THE ELDERLY

    The amount and speed of fluid supplementation should be strictly controlled.

  • DRUG INTERACTIONS

    Should not be used with drugs with known incompatibility contraindications.

  • DRUG OVERDOSE

    For those with existing acidosis, a large amount of this product can cause hyperchloric acidosis.

  • PHARMACOLOGY AND TOXICOLOGY

    Sodium and chlorine are important electrolytes in the body, mainly in the extracellular fluid, and play a very important role in maintaining the normal blood and extracellular fluid volume and osmotic pressure of the human body. The normal serum sodium concentration is 135~145mmol/L, accounting for 92% of the plasma cation and 90% of the total osmotic pressure, so the amount of plasma sodium plays a decisive role in the osmotic pressure. The normal serum chlorine concentration is 98~106mmol/L, which is mainly regulated by the human body through the hypothalamus, posterior pituitary and kidney to maintain the stability of body fluid volume and osmotic pressure.

  • PHARMACOKINETICS

    In the gastrointestinal tract, sodium is absorbed almost entirely through the active transport of intestinal mucosal cells. Sodium is excreted primarily by the kidneys.

  • STORAGE

    Sealed storage.

  • PACKAGE

    1. Plastic infusion bag (non-PVC co-extruded film, double hard tube, easy to fold, double valve and double plug). 50ml/ bag, 100ml/ bag, 250ml/ bag, 500ml/ bag, 10O0ml/ bag.
    2. Plastic infusion bag (non-PVC co-extruded film, double hard tube, easy to fold, double valve double plug, double aseptic packaging). 50ml/ bag, 100ml/ bag, 250ml/ bag, 500ml/ bag, 1000ml/ bag.

  • VALIDITY

    1. The product of 50ml,100ml, and 1000ml specifications is valid for 24 months.
    2. The validity period of 250ml,500ml is 36 months.
  • OTHER INFORMATION

    [EXECUTIVE STANDARD]

    Pharmacopoeia of the People's Republic of China (2020, Volume II)

    [APPROVAL NUMBER]

    GuoYaoZhunZi: H20033208 (50ml: 0.45g)

    GuoYaoZhunZi: H20023682 (100ml: 0.9g)

    GuoYaoZhunZi: H20023146 (250ml: 2.25g)

    GuoYaoZhunZi: H20023145 (500ml: 4.5g)

    GuoYaoZhunZi: H20023750 (1000ml: 9g)

    [PHARMACEUTICAL MARKETING AUTHORIZATION HOLDER]

    Name: Huaren Pharmaceutical Co., Ltd.

    Registered Address: No. 187, Zhuzhou Road, Qingdao High-tech Park, China.

    [MANUFACTURER]

    Enterprise Name: Huaren Pharmaceutical Co., Ltd.

    Production Address: No. 187, Zhuzhou Road, Qingdao High-tech Park, China. Zip code: 266101

    Tel.: 400-0648885 0532-67709071

    Fax: 0532-88702625

    Website: http//www.qdhuaren.com

  • HEALTH CARE PROVIDER LETTER pg.1

    HEALTH CARE PROVIDER LETTER pg.1

  • HEALTH CARE PROVIDER LETTER pg.2

    HEALTH CARE PROVIDER LETTER pg.2

  • HEALTH CARE PROVIDER LETTER pg.3

    HEALTH CARE PROVIDER LETTER pg.3

  • PACKAGE LABEL– 0.9% Sodium Chloride 1000 mL Bag Label

    PACKAGE LABEL– 0.9% Sodium Chloride 1000 mL Bag

  • PACKAGE LABEL– 0.9% Sodium Chloride 500 mL Bag Label

    PACKAGE LABEL– 0.9% Sodium Chloride 500 mL Bag

  • PACKAGE LABEL– 0.9% Sodium Chloride 250 mL Bag Label

    PACKAGE LABEL– 0.9% Sodium Chloride 250 mL Bag

  • PACKAGE LABEL– 0.9% Sodium Chloride 100 mL Bag Label

    PACKAGE LABEL– 0.9% Sodium Chloride 100 mL Bag

  • PACKAGE LABEL– 0.9% Sodium Chloride 50 mL Bag Label

    PACKAGE LABEL– 0.9% Sodium Chloride 50 mL Bag

  • INGREDIENTS AND APPEARANCE
    SODIUM CHLORIDE 0.9% 
    sodium chloride injection, solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:85268-806
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, 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:85268-806-0260 in 1 BOX03/07/2025
    1NDC:85268-806-0150 mL in 1 BAG; Type 0: Not a Combination Product
    2NDC:85268-806-0450 in 1 BOX03/07/2025
    2NDC:85268-806-03100 mL in 1 BAG; Type 0: Not a Combination Product
    3NDC:85268-806-0630 in 1 BOX03/07/2025
    3NDC:85268-806-05250 mL in 1 BAG; Type 0: Not a Combination Product
    4NDC:85268-806-0820 in 1 BOX03/07/2025
    4NDC:85268-806-07500 mL in 1 BAG; Type 0: Not a Combination Product
    5NDC:85268-806-1010 in 1 BOX03/07/2025
    5NDC:85268-806-091000 mL in 1 BAG; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/07/2025
    Labeler - Huaren Pharmaceutical Co., Ltd. (547602854)