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FDA Drug information

Sodium Chloride

Read time: 1 mins
Marketing start date: 25 Mar 2025
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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

0338-9810

Product Type

HUMAN PRESCRIPTION DRUG

Route

INTRAVENOUS

Package Label Principal Display Panel

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Container Label Baxter Logo Trademark A6C1322 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 GTIN Barcode Area LOT MFG EXP Container Label Baxter Logo Trademark A6C1323 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 GTIN Barcode Area LOT MFG EXP Container Label Baxter Logo Trademark A6C1324 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 GTIN Barcode Area LOT MFG EXP Sodium Chloride A6C1322 Representative Container Label.jpg Sodium Chloride A6C1323 Representative Container Label.jpg Sodium Chloride A6C1324 Representative Container Label.jpg

Spl Unclassified Section

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

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