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FDA Drug information

Sodium Chloride

Read time: 1 mins
Marketing start date: 14 Feb 2025

Summary of product characteristics


Effective Time

20241121

Version

3

Spl Product Data Elements

Sodium Chloride Sodium Chloride SODIUM CHLORIDE SODIUM CATION CHLORIDE ION WATER Sodium Chloride Sodium Chloride SODIUM CHLORIDE SODIUM CATION CHLORIDE ION WATER Sodium Chloride Sodium Chloride SODIUM CHLORIDE SODIUM CATION CHLORIDE ION WATER

Brand Name

Sodium Chloride

Generic Name

Sodium Chloride

Product Ndc

0338-9793

Product Type

HUMAN PRESCRIPTION DRUG

Route

INTRAVENOUS

Package Label Principal Display Panel

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Baxter Logo Trademark A6C1322US SODIUM CHLORIDE INJECTION 50 100 150 200 250ml 0.9% Sodium Chloride [Strength] 250ml: 2.25g [Description] This product is a clear, colorless liquid [Dosage and Administration] Intravenous drip See the package insert for details For details of [Indications], [Adverse Reactions], [Contraindications], and [Precautions], please refer to the package insert [Storage] Store in overwrap The solution should be clear and should be used up at one time Inspect the inner bag by squeezing it and discard solution if leakage occurs License Number: H19994066 AA [Drug Marketing Authorization Holder] [Manufacturer] Name: Baxter Healthcare (Shanghai) Co., Ltd. Address: No. 388, Tingzhu Road, Jinshan District, Shanghai Barcode (01)00303389791010 LOT MFG EXP 0.9% Sodium Chloride Injection 250ml X 40 LOT S0000000 EXP YYYY-MM A6C1322US 1C/N LIC H19994066 0.9% Sodium Chloride Injection 250ml X 40 LOT S0000000 EXP YYYY-MM MFG YYYY-MM-DD 1C/N 0000 Baxter Logo Trademark A6C1323US SODIUM CHLORIDE INJECTION 100 200 300 400 500ml 0.9% Sodium Chloride [Strength] 500ml: 4.5g [Description] This product is a clear, colorless liquid [Dosage and Administration] Intravenous drip See the package insert for details For details of [Indications], [Adverse Reactions], [Contraindications], and [Precautions], please refer to the package insert [Storage] Store in overwrap The solution should be clear and should be used up at one time Inspect the inner bag by squeezing it and discard solution if leakage occurs License Number: H19983148 AA [Drug Marketing Authorization Holder] [Manufacturer] Name: Baxter Healthcare (Shanghai) Co., Ltd. Address: No. 388, Tingzhu Road, Jinshan District, Shanghai Barcode (01)00303389808015 LOT MFG EXP 0.9% Sodium Chloride Injection 500ml X 24 LOT S0000000 EXP YYYY-MM A6C1323US 1C/N LIC H19983148 0.9% Sodium Chloride Injection 500ml X 24 LOT S0000000 EXP YYYY-MM MFG YYYY-MM-DD 1C/N 0000 Baxter Logo Trademark A6C1324US SODIUM CHLORIDE INJECTION 100 200 300 400 500 600 700 800 900 1000ml 0.9% Sodium Chloride [Strength] 1000ml: 9g [Description] This product is a clear, colorless liquid [Dosage and Administration] Intravenous drip See the package insert for details For details of [Indications], [Adverse Reactions], [Contraindications], and [Precautions], please refer to the package insert [Storage] Store in overwrap The solution should be clear and should be used up at one time Inspect the inner bag by squeezing it and discard solution if leakage occurs License Number: H19983149 AA [Drug Marketing Authorization Holder] [Manufacturer] Name: Baxter Healthcare (Shanghai) Co., Ltd. Address: No. 388, Tingzhu Road, Jinshan District, Shanghai Barcode (01)00303389793014 LOT MFG EXP 0.9% Sodium Chloride Injection 1000ml X 12 LOT S0000000 EXP YYYY-MM A6C1324US 1C/N LIC H19983149 0.9% Sodium Chloride Injection 1000ml X 12 LOT S0000000 EXP YYYY-MM MFG YYYY-MM-DD 1C/N 0000 Sodium Chloride A6C1322US Representative Carton Label 1.jpg Sodium Chloride A6C1322US Representative Carton Label 2.jpg Sodium Chloride A6C1323US Representative Carton Label 1.jpg Sodium Chloride A6C1323US Representative Carton Label 2.jpg Sodium Chloride A6C1324US Representative Carton Label 1.jpg Sodium Chloride A6C1324US Representative Carton Label 2.jpg

Spl Unclassified Section

PACKAGE INSERT Spec301US Image 1.jpg Spec301US Image 2.jpg Spec301US Image 3.jpg Spec301US Image 4.jpg Spec303US Image 1.jpg Spec303US Image 2.jpg Spec303US Image 3.jpg Spec303US Image 4.jpg

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