0.9% Sodium Chloride Injection in UNIFLEX Plastic Container

Sodium Chloride by

Drug Labeling and Warnings

Sodium Chloride by is a Prescription medication manufactured, distributed, or labeled by ApiJect Systems Corp, Sichuan Kelun Pharmaceutical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SODIUM CHLORIDE- sodium chloride injection, solution 
ApiJect Systems Corp

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.

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0.9% Sodium Chloride Injection
in UNIFLEX Plastic Container

HEALTH CARE PROVIDER LETTER

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

SODIUM CHLORIDE 
sodium chloride injection, solution

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 84898-911
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	9 g  in 1000 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84898-911-02	40 in 1 CARTON	11/18/2024
1		250 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 for use in drug shortage		11/18/2024	12/31/2024

Labeler - ApiJect Systems Corp (117008506)

Establishment
Name	Address	ID/FEI	Business Operations
Sichuan Kelun Pharmaceutical Co., Ltd.		529053803	analysis(84898-911) , label(84898-911) , manufacture(84898-911)

Revised: 3/2025

Document Id: 30d1c17c-4f2d-8a0a-e063-6394a90ab612

34391-3

Set id: bed50743-5109-4f1f-a85c-175fbfa72902

Version: 3

Effective Time: 20250320