Sodium Chloride by Lifestar Pharma LLC / Mankind Pharma Limited SODIUM CHLORIDE-

Sodium Chloride by

Drug Labeling and Warnings

Sodium Chloride by is a Other medication manufactured, distributed, or labeled by Lifestar Pharma LLC, Mankind Pharma Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Sodium Chloride Inhalation Solution 0.9% 3 mL

NDC: 70756-661-99

Sodium Chloride Inhalation
Solution, USP
0.9% 3 mL

For Respiratory Therapy

Not for Parenteral Administration.

100 x 3 mL Sterile Unit-Dose Vials

Rx Only

Sodium Chloride Inhalation Solution, USP
0.9% 3 mL

Sterile, non-pyrogenic, preservative-free single-use vials for respiratory therapy. No bacteriostatic agent or other preservative added.

INDICATIONS: Contents of these vials are for use in respiratory therapy and for tracheal irrigation or lavage.

WARNING: Not for injection or in preparations to be used for injection.

DIRECTIONS FOR USE: To verify container integrity, squeeze the vial before use. Twist cap completely off vial, invert and squeeze prescribed volume.

Discard any unused portion of the contents of this single-use vial as well as any unused solution remaining in the nebulizer cup.

HOW SUPPLIED: Single-use plastic vials containing 3 mL or 5 mL solutions supplied in cartons of 100 vials and 15 mL solution supplied in cartons of 50 vials.

NDC: 70756-661-99 Sodium Chloride Inhalation Solution, USP 0.9%, 3 mL
NDC: 70756-662-99 Sodium Chloride Inhalation Solution, USP 0.9%, 5 mL

Internal contents sterile. External surface of vial not sterile.

STORAGE: Store at controlled room temperature 15° to 30°C (59° to 86°F).

For Customer Service, Call 1-888-995-4337

Manufactured for: 

Lifestar Pharma LLC
1200 MacArthur Blvd.
Mahwah, NJ 07430 USA

Made in India

Rev: 05/23,V-01

INGREDIENTS AND APPEARANCE

SODIUM CHLORIDE 
nebulizer (direct patient interface)

Product Information
Product Type	MEDICAL DEVICE	Item Code (Source)	NHRIC:70756-661

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM CHLORIDE	0.027 g  in 3 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:70756-661-99	100 in 1 CARTON
1		3 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
premarket notification	K232523	05/01/2024

Labeler - Lifestar Pharma LLC (080268943)

Registrant - Mankind Pharma Limited (915834068)

Establishment
Name	Address	ID/FEI	Business Operations
Mankind Pharma Limited		916512493	manufacture, analysis, pack