Label: SODIUM CHLORIDE 0.9%- sodium chloride injection, solution
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NDC Code(s):
85268-806-01,
85268-806-02,
85268-806-03,
85268-806-04, view more85268-806-05, 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.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SODIUM CHLORIDE INJECTION, USP BAG
- INGREDIENTS
- CHARACTER
- INDICATIONS
- SPECIFICATION
- DOSAGE AND USAGE
- ADVERSE REACTIONS
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PRECAUTIONS
Use with caution in the following cases:
- Edematous diseases, such as nephrotic syndrome, cirrhosis, ascites, congestive heart failure, acute left heart failure, brain edema, and idiopathic edema
- Acute renal failure, oliguria stage, chronic renal failure, urine volume decreased, and poor response to diuretic drugs;
- Hypertension;
- Hypokalemia.
Follow-up examination:
- Serum sodium, potassium, chlorine concentration;
- Blood acid-base balance index;
- Kidney function;
- Blood pressure and cardiopulmonary function.
- MEDICATION IN PREGNANT WOMEN AND LACTATING WOMEN
- MEDICATION IN CHILDREN
- MEDICATION IN THE ELDERLY
- DRUG INTERACTIONS
- DRUG OVERDOSE
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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
- STORAGE
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PACKAGE
- 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.
- 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
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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.2
- HEALTH CARE PROVIDER LETTER pg.3
- PACKAGE LABEL– 0.9% Sodium Chloride 1000 mL Bag Label
- PACKAGE LABEL– 0.9% Sodium Chloride 500 mL Bag Label
- PACKAGE LABEL– 0.9% Sodium Chloride 250 mL Bag Label
- PACKAGE LABEL– 0.9% Sodium Chloride 100 mL Bag Label
- PACKAGE LABEL– 0.9% Sodium Chloride 50 mL Bag Label
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INGREDIENTS AND APPEARANCE
SODIUM CHLORIDE 0.9%
sodium chloride injection, solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:85268-806 Route of Administration INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 0.9 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:85268-806-02 60 in 1 BOX 03/07/2025 1 NDC:85268-806-01 50 mL in 1 BAG; Type 0: Not a Combination Product 2 NDC:85268-806-04 50 in 1 BOX 03/07/2025 2 NDC:85268-806-03 100 mL in 1 BAG; Type 0: Not a Combination Product 3 NDC:85268-806-06 30 in 1 BOX 03/07/2025 3 NDC:85268-806-05 250 mL in 1 BAG; Type 0: Not a Combination Product 4 NDC:85268-806-08 20 in 1 BOX 03/07/2025 4 NDC:85268-806-07 500 mL in 1 BAG; Type 0: Not a Combination Product 5 NDC:85268-806-10 10 in 1 BOX 03/07/2025 5 NDC:85268-806-09 1000 mL in 1 BAG; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 03/07/2025 Labeler - Huaren Pharmaceutical Co., Ltd. (547602854)








