Sodium Chloride

Hikma Pharmaceuticals Usa Inc.
Human Prescription Drug
NDC 0641-6144

Sodium Chloride is a human prescription drug labeled by 'Hikma Pharmaceuticals Usa Inc.'. National Drug Code (NDC) number for Sodium Chloride is 0641-6144. This drug is available in dosage form of Injection. The names of the active, medicinal ingredients in Sodium Chloride drug includes Sodium Chloride - 9 mg/mL . The currest status of Sodium Chloride drug is Active.

Drug Information:

Drug NDC:	0641-6144
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name:	Sodium Chloride
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type:	Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name:	Sodium Chloride
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Hikma Pharmaceuticals Usa Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Injection
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status:	Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:	SODIUM CHLORIDE - 9 mg/mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	INTRAMUSCULAR INTRAVENOUS SUBCUTANEOUS
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Marketing Category:	ANDA
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date:	24 Sep, 2013
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	02 Jun, 2024
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number:	ANDA201833
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Listing Expiration Date:	31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

Manufacturer Name:	Hikma Pharmaceuticals USA Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:	1807636 1807637
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:	Yes
Whether or not the drug has been repackaged for distribution.
UNII:	451W47IQ8X
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class:	Increased Large Intestinal Motility [PE] Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] Osmotic Activity [MoA] Osmotic Laxative [EPC]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
0641-6144-25	25 VIAL in 1 CARTON (0641-6144-25) / 10 mL in 1 VIAL (0641-6144-01)	24 Sep, 2013	N/A	No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

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Product Elements:

Sodium chloride sodium chloride sodium chloride sodium cation chloride ion sodium hydroxide hydrochloric acid water sodium chloride sodium chloride sodium chloride sodium cation chloride ion sodium hydroxide hydrochloric acid water

Drug Interactions:

Drug interactions some drugs for injection may be incompatible in a given vehicle, or when combined in the same vehicle or in a vehicle containing benzyl alcohol. consult with pharmacist, if available. use aseptic technique for entry and withdrawal from all containers. when diluting or dissolving drugs, mix thoroughly and use promptly. do not store reconstituted solutions of drugs for injection unless otherwise directed by the manufacturer of the solute. do not use unless the solution is clear and seal intact. do not reuse single dose containers, discard unused portion.

Indications and Usage:

Indications and usage this parenteral preparation indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.

General Precautions:

General consult the manufacturers instructions for choice of vehicle, appropriate dilution or volume for dissolving the drugs to be injected, including the route and rate of injection. inspect reconstituted (diluted or dissolved) drugs for clarity (if soluble) and freedom from unexpected precipitation or discoloration prior to administration.

Dosage and Administration:

Dosage and administration the volume of the preparation to be used for diluting or dissolving any drug for injection, is dependent on the vehicle concentration, dose and route of administration as recommended by the manufacturer. this parenteral should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Adverse Reactions:

Adverse reactions reactions which may occur because of this solution, added drugs or the technique of reconstitution or administration include febrile response, local tenderness, abscess, tissue necrosis or infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection and extravasation. if an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate countermeasures, and if possible, retrieve and save the remainder of the unused vehicle for examination.

Drug Interactions:

Use in Pregnancy:

Pregnancy pregnancy category c animal reproduction studies have not been conducted with sodium chloride injection usp, 0.9%. it is also not known whether sodium chloride injection containing additives can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. sodium chloride injection containing additives should be given to a pregnant woman only if clearly needed.

Pediatric Use:

Pediatric use the safety and effectiveness in the pediatric population are based on the similarity of the clinical conditions of the pediatric and adult populations. in neonates or very small infants the volume of fluid may affect fluid and electrolyte balance.

Overdosage:

Overdosage use only as a diluent or solvent. this parenteral preparation is unlikely to pose a threat of carbohydrate, sodium chloride or fluid overload except possibly in neonates or very small infants. in the event these should occur, re-evaluate the patient and institute appropriate corrective measures. see precautions and adverse reactions .

Description:

Description this preparation is designed solely for parenteral use only after addition of drugs that require dilution or must be dissolved in an aqueous vehicle prior to injection. sodium chloride injection usp, 0.9% is a sterile, nonpyrogenic, isotonic solution of sodium chloride and water for injection. each ml contains sodium chloride 9 mg. it contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single-dose containers to dilute or dissolve drugs for injection. its chloride and sodium ion concentrations are approximately 0.154 meq of each per milliliter and its calculated osmolality is 0.308 milliosmols per ml. the solution may contain hydrochloric acid and/or sodium hydroxide for ph adjustment, ph 5.3 (4.5 to 7.0). sodium chloride, usp occurs as colorless cubic crystals or white crystalline powder and has a saline taste. sodium chloride is freely soluble in water. the empirical formula for sodium chloride is nacl, and the molecular weight is 58.44.

Clinical Pharmacology:

Clinical pharmacology sodium chloride in water dissociates to provide sodium (na + ) and chloride (cl ) ions. these ions are normal constituents of the body fluids (principally extracellular) and are essential for maintaining electrolyte balance. the distribution and excretion of sodium (na + ) and chloride (cl ) are largely under the control of the kidney which maintains a balance between intake and output. the small volume of fluid and amount of sodium chloride provided by sodium chloride injection usp, 0.9% when used only as an isotonic vehicle for parenteral injection of drugs, is unlikely to exert a significant effect on fluid and electrolyte balance except possibly in neonates and very small infants. water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. average normal adult daily requirement ranges from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production). water b Read more...

alance is maintained by various regulatory mechanisms. water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (na + ) plays a major role in maintaining physiologic equilibrium.

How Supplied:

How supplied sodium chloride injection usp, 0.9% is supplied in the following: 2 ml vials packaged in carton of 25 vials (ndc 0641-0497-25) 10 ml vials packaged in carton of 25 vials (ndc 0641-6144-25) storage store at 20° - 25°c (68°-77°f), excursions permitted to 15° - 30°c (59° - 86°f) [see usp controlled room temperature]. avoid freezing.

Package Label Principal Display Panel:

Principal display panel ndc 0641- 0497 -17 rx only sodium chloride injection usp, 0.9% 0.308 mosmol/ml preservative free for use as a sterile diluent 2 ml single dose vial ndc 0641- 0497 -25 rx only sodium chloride injection usp, 0.9% 0.308 mosmol/ml preservative free for use as a sterile diluent 25 x 2 ml single dose vials vial shelfpack

Principal display panel ndc 0641-6144-01 rx only sodium chloride injection usp, 0.9% 0.308 mosmol/ml preservative-free for use as a sterile diluent 10 ml single dose vial each ml contains sodium chloride 9 mg in water for injection; ph 4.5-7.0, may contain hydrochloric acid and/or sodium hydroxide for ph adjustment. sterile, nonpyrogenic. contains no preservative. discard unused portion. for additional information, see package insert. store at 20º-25ºc (68º-77ºf) [see usp controlled room temperature]. ndc 0641-6144-25 rx only sodium chloride injection usp, 0.9% 0.308 mosmol/ml preservative-free for use as a sterile diluent 25 x 10 ml single dose vials each ml contains sodium chloride 9 mg in water for injection; ph 4.5-7.0, may contain hydrochloric acid and/or sodium hydroxide for ph adjustment. sterile, nonpyrogenic. contains no preservative. discard unused portion. for additional information, see package insert. store at 20º-25ºc (68º-77ºf) [see usp controlled room temperature]. ndc 0641-6144-01 rx only sodium chloride injection usp, 0.9% 0.308 mosmol/ml preservative-free for use as a sterile diluent 10 ml single dose vial each ml contains sodium chloride 9 mg in water for injection; ph 4.5-7.0, may contain hydrochloric acid and/or sodium hydroxide for ph adjustment. sterile, nonpyrogenic. contains no preservative. discard unused portion. for additional information, see package insert. store at 20º-25ºc (68º-77ºf) [see usp controlled room temperature]. ndc 0641-6144-25 rx only sodium chloride injection usp, 0.9% 0.308 mosmol/ml preservative-free for use as a sterile diluent 25 x 10 ml single dose vials each ml contains sodium chloride 9 mg in water for injection; ph 4.5-7.0, may contain hydrochloric acid and/or sodium hydroxide for ph adjustment. sterile, nonpyrogenic. contains no preservative. discard unused portion. for additional information, see package insert. store at 20º-25ºc (68º-77ºf) [see usp controlled room temperature].

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Comments/ Reviews:

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