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FDA Drug information

Sodium Chloride

Read time: 1 mins
Marketing start date: 20 Apr 2025
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Summary of product characteristics


Effective Time

20241117

Version

2

Spl Product Data Elements

Sodium Chloride Sodium Chloride WATER SODIUM CHLORIDE SODIUM CATION CHLORIDE ION

Brand Name

Sodium Chloride

Generic Name

Sodium Chloride

Product Ndc

84898-911

Product Type

HUMAN PRESCRIPTION DRUG

Route

INTRAVENOUS

Package Label Principal Display Panel

Translation: UniFlex SODIUM CHLORIDE INJECTION 2.25g / 250ml 0.9% Registration Approval No.: GYZZ H51021157 ATTENTION: Visually inspect the container. Check for minute leaks by squeezing bag firmly. If leaks are found, discard solution. Do not use the drug solution if particulate matter is visible. [Usage] See product insert [Storage] in a closed environment [Packaging] UniFlex Polypropylene Bag [LOT] [EXP] [MFG] Manufacturer: Sichuan Kelun Pharmaceutical Co., Ltd. Translation: Do not open with sharp object. Do not stack higher than 12 layers. Qualification printed on flap Qualification For any quality issues or quantitative insufficiencies, please contact: Hotline: 4006860333, from Monday to Friday: 08:00-17:30, excluding official holidays. Company Website: www.kelun.com Store as per storage requirements to ensure quality of drug products. UniFlex Polypropylene Bag SODIUM CHLORIDE INJECTION 0.9% Registration Approval No.: GYZZH51021157 250ml Product Information LOT EXP MFG Sichuan Kelun Pharmaceutical Co., Ltd. 250ml Stack upwards, Protect from moisture and light Authorized Holder: Name: Sichuan Kelun Pharmaceutical Co., Ltd. Address: South of No. 2 Road, Xindu Satellite City Industrial Development Zone, Chengdu, Sichuan, P. R. China Manufacturer: Name: Sichuan Kelun Pharmaceutical Co., Ltd. Address: South of No. 2 Road, Xindu Satellite City Industrial Development Zone, Chengdu, Sichuan, P. R. China Postal code: 610500 Hotline: 4006860333 Company website: www.kelun.com Sichuan Kelun Pharmaceutical Co., Ltd. UniFlex Polypropylene Bag SODIUM CHLORIDE INJECTION 0.9% Registration Approval No.: GYZZH51021157 250ml Product Information LOT EXP MFG Sichuan Kelun Pharmaceutical Co., Ltd. 250ml Stack upwards, Protect from moisture and light Product name: SODIUM CHLORIDE INJECTION (0.9%) Strength: 2.25g / 250ml Packaging: UniFlex Polypropylene Bag, 250ml/bag, 40 bags/carton Gross weight: 12 kg Volume: 485× 345 × 200 mm3 Storage: Store in an enclosed environment. Sichuan Kelun Pharmaceutical Co., Ltd. Size: 150mmⅹ70mm SODIUM CHLORIDE INJECTION UniFlex Plastic Container 250 mL "Pack size: 40 containers/carton LOT: EXP: MFG:" Storage: Store at room temperature (10°C-30°C). Do not freeze. "Imported by: ApiJect Systems Corp. 2 High Ridge Park, Stamford, CT 06905 USA Tel: 855-826-4885" Manufactured by: Sichuan Kelun Pharmaceutical Co., Ltd. South of No.2 Road, Xindu Satellite City Industrial Development Zone, Chengdu, Sichuan, P.R.China image description image description image description

Package Label Principal Display Panel Table

Do not open with sharp object. Do not stack higher than 12 layers. Qualification printed on flap Qualification For any quality issues or quantitative insufficiencies, please contact: Hotline: 4006860333, from Monday to Friday: 08:00-17:30, excluding official holidays. Company Website: www.kelun.com Store as per storage requirements to ensure quality of drug products.
UniFlex Polypropylene Bag SODIUM CHLORIDE INJECTION

0.9% Registration Approval No.: GYZZH51021157

250ml

Product Information

LOT EXP MFG

Sichuan Kelun Pharmaceutical Co., Ltd.

 250ml Stack upwards, Protect from moisture and light

Authorized Holder: Name: Sichuan Kelun Pharmaceutical Co., Ltd. Address: South of No. 2 Road, Xindu Satellite City Industrial Development Zone, Chengdu, Sichuan, P. R. China Manufacturer: Name: Sichuan Kelun Pharmaceutical Co., Ltd. Address: South of No. 2 Road, Xindu Satellite City Industrial Development Zone, Chengdu, Sichuan, P. R. China Postal code: 610500 Hotline: 4006860333 Company website: www.kelun.com

Sichuan Kelun Pharmaceutical Co., Ltd.

UniFlex Polypropylene Bag SODIUM CHLORIDE INJECTION

0.9% Registration Approval No.: GYZZH51021157

250ml

Product Information

LOT EXP MFG

Sichuan Kelun Pharmaceutical Co., Ltd.

250ml Stack upwards, Protect from moisture and light

Product name: SODIUM CHLORIDE INJECTION (0.9%) Strength: 2.25g / 250ml Packaging: UniFlex Polypropylene Bag, 250ml/bag, 40 bags/carton Gross weight: 12 kg Volume: 485× 345 × 200 mm3 Storage: Store in an enclosed environment.

Sichuan Kelun Pharmaceutical Co., Ltd.

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