84879-263 NDC - POLIFLEKS (0.9% ISOTONIC SODIUM CHLORIDE)

Drug Information

Product NDC: 84879-263
Proprietary Name: Polifleks
Non Proprietary Name: 0.9% Isotonic Sodium Chloride
Active Ingredient(s): .9 g/100mL ISOTONIC SODIUM CHLORIDE SOLUTION
Administration Route(s): INTRAVENOUS
Dosage Form(s): SOLUTION
Pharmacy Class(es): Increased Large Intestinal Motility [PE]; Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]; Osmotic Activity [MoA]; Osmotic Laxative [EPC]

Labeler Information

Field Name	Field Value
Labeler Name:	POLIFARMA ILAC SANAYI VE TICARET ANONIM SIRKETI CORLU SUBESI
Product Type:	HUMAN PRESCRIPTION DRUG
FDA Application Number:
Marketing Category:	UNAPPROVED DRUG OTHER
Start Marketing Date:	3/10/2025

Package Information

No.	Package Code	Package Description	Billing Unit
1	84879-263-01	50 mL in 1 BAG (84879-263-01)
2	84879-263-02	250 mL in 1 BAG (84879-263-02)
3	84879-263-03	500 mL in 1 BAG (84879-263-03)
4	84879-263-04	1000 mL in 1 BAG (84879-263-04)
5	84879-263-05	3000 mL in 1 BAG (84879-263-05)

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	84879-263	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.
PRODUCT TYPE NAME	HUMAN PRESCRIPTION DRUG	Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAME	Polifleks	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAME	0.9% Isotonic Sodium Chloride	The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAME	SOLUTION	The translation of the dosage form Code submitted by the firm.
ROUTE NAME	INTRAVENOUS	The translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE	3/10/2025	This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAME	UNAPPROVED DRUG OTHER	Product types are broken down into several potential Marketing Categories, such as NDA/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.
LABELER NAME	POLIFARMA ILAC SANAYI VE TICARET ANONIM SIRKETI CORLU SUBESI	Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAME	ISOTONIC SODIUM CHLORIDE SOLUTION	An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH	.9
ACTIVE INGRED UNIT	g/100mL
PHARM CLASSES	Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]

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This page was last updated on: 11/21/2025

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