NDC 70369-007 Sodium Chloride Normal Salt

Sodium Chloride

NDC Product Code 70369-007

NDC Code: 70369-007

Proprietary Name: Sodium Chloride Normal Salt Additional informationCallout TooltipWhat 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.

Non-Proprietary Name: Sodium Chloride Additional informationCallout TooltipWhat 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.


Product Characteristics
Color(s):
WHITE (C48325)
Shape: ROUND (C48348)
Size(s):
12 MM
Imprint(s):
CG007
Score: 1

Code Structure
  • 70369 - Citragen Pharmaceuticals Inc
    • 70369-007 - Sodium Chloride

NDC 70369-007-02

Package Description: 500 TABLET in 1 BOTTLE

NDC 70369-007-03

Package Description: 100 TABLET in 1 BOTTLE

NDC Product Information

Sodium Chloride Normal Salt with NDC 70369-007 is a a human over the counter drug product labeled by Citragen Pharmaceuticals Inc. The generic name of Sodium Chloride Normal Salt is sodium chloride. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Citragen Pharmaceuticals Inc

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

Product Type: Human Otc Drug Additional informationCallout TooltipWhat 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.


Sodium Chloride Normal Salt Active Ingredient(s)

Additional informationCallout TooltipWhat is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • SODIUM CHLORIDE 1 g/1

Administration Route(s)

Additional informationCallout TooltipWhat are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Citragen Pharmaceuticals Inc
Labeler Code: 70369
FDA Application Number: part349 Additional informationCallout TooltipWhat 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.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. Additional informationCallout TooltipWhat 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.

Start Marketing Date: 03-22-2019 Additional informationCallout TooltipWhat is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 Additional informationCallout TooltipWhat is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N Additional informationCallout TooltipWhat 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Sodium Chloride Normal Salt Product Label Images

Sodium Chloride Normal Salt Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Drug Facts

Active ingredient (in each tablet)Sodium Chloride, USP 1.0 gram

Purpose

Electrolyte Replenisher

Uses

  • For the preparation of normal isotonic solution of sodium chlorideas an electrolyte replenisher for the prevention of heat cramps due to excessive perspirationany alternative use as directed by a physician

Otc - Do Not Use

Do not use without consulting a physician

Otc - Ask Doctor

Ask a physician before use if you have a sodium restricted diet due to multiple organ diseases

Otc - Stop Use

Stop use and ask a physician if symptoms of heat cramps continue for more than 24 hours.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Overdosage

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • To make isontonic solution of sodium chloride, dissolve one tablet in 120 ml (four ounces) of distilled water and use as directed by a physician.if used as an electrolyte replenisher for the prevention of heat cramps due to excessive perspiration take one tablet orally as directed by your physician.

Other Information:

  • Each tablet contains: sodium 394 mg
  • Store at room temperature 15°-30°C (59°-86°F)product does not contain any inactive ingredients

Other

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSINGManufactured by:CitraGen Pharmaceuticals, Inc.,

Fremont, CA 94538.
www.citragenpharma.comRev. 02/19 R-00

* Please review the disclaimer below.

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