NDC 0019-1188 Sodium Chloride
Injection Intravascular

Table of Contents

    1. Product Information
    2. Product Packages
    3. What is NDC 0019-1188?
    4. Sodium Chloride Uses
    5. Active Ingredients
    6. Active Ingredients UNII Codes
    7. Inactive Ingredients UNII Codes
    8. Pharmacologic Classes

Product Information

NDC Product Code0019-1188
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.		Sodium Chloride
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.		Sodium Chloride
Substance Name What is the Substance Name?
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.		Sodium Chloride
Product Type What kind of product is this?
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.		Human Prescription Drug
NDC Directory StatusACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage FormInjection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Intravascular - Administration within a vessel or vessels.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		Liebel-flarsheim Company Llc
Labeler Code0019
SPL SET ID:e4540d03-06b4-4b4d-b859-75c13e5c20dd
FDA Application Number What is the FDA Application Number?
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.		NDA021569
Marketing Category What is the Marketing Category?
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.		NDA - A product marketed under an approved New Drug Application.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.		09-01-2012
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.		12-31-2023
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I". 		N
NDC Code Structure

Product Packages

NDC Code 0019-1188-27

Package Description: 20 BOX in 1 CARTON / 1 SYRINGE, PLASTIC in 1 BOX / 125 mL in 1 SYRINGE, PLASTIC

NDC Code 0019-1188-81

Package Description: 20 BOX in 1 CARTON / 1 SYRINGE, PLASTIC in 1 BOX / 125 mL in 1 SYRINGE, PLASTIC

Product Details

What is NDC 0019-1188?

The NDC code 0019-1188 is assigned by the FDA to the product Sodium Chloride which is a human prescription drug product labeled by Liebel-flarsheim Company Llc. The product's dosage form is injection and is administered via intravascular form. The product is distributed in 2 packages with assigned NDC codes 0019-1188-27 20 box in 1 carton / 1 syringe, plastic in 1 box / 125 ml in 1 syringe, plastic, 0019-1188-81 20 box in 1 carton / 1 syringe, plastic in 1 box / 125 ml in 1 syringe, plastic. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Sodium Chloride?

This solution is used to supply water and salt (sodium chloride) to the body. Sodium chloride solution may also be mixed with other medications given by injection into a vein.

What are Sodium Chloride Active Ingredients?

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.

Which are Sodium Chloride UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Sodium Chloride Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

Which are the Pharmacologic Classes for Sodium Chloride?

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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