Normal Salt
Sodium Chloride
Graxcell Pharmaceutical, Llc
Human Otc Drug
NDC 70795-1120Normal Salt also known as Sodium Chloride is a human otc drug labeled by 'Graxcell Pharmaceutical, Llc'. National Drug Code (NDC) number for Normal Salt is 70795-1120. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Normal Salt drug includes Sodium Chloride - 1 g/1 . The currest status of Normal Salt drug is Active.
Drug Information:
Drug NDC: | 70795-1120 |
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: | Normal Salt |
Also known as the trade name. It is the name of the product chosen by the labeler. |
Product Type: | Human Otc 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: | Graxcell Pharmaceutical, Llc |
Name of Company corresponding to the labeler code segment of the ProductNDC. |
Dosage Form: | Tablet |
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 - 1 g/1
|
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
Route Details: | ORAL
|
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: | OTC MONOGRAPH FINAL |
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: | 02 Oct, 2017 |
This is the date that the labeler indicates was the start of its marketing of the drug product. |
Marketing End Date: | 16 Jan, 2025 |
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: | part349 |
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: | GRAXCELL PHARMACEUTICAL, LLC
|
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
RxCUI: | 313009
|
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. |
UPC: | 0867017000405
|
UPC stands for Universal Product Code. |
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. |
Packaging Information:
Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
---|
70795-1120-0 | 1000 TABLET in 1 BOTTLE (70795-1120-0) | 02 Oct, 2017 | N/A | No |
70795-1120-1 | 120 TABLET in 1 BOTTLE (70795-1120-1) | 02 Oct, 2017 | N/A | No |
70795-1120-3 | 300 TABLET in 1 BOTTLE (70795-1120-3) | 16 Nov, 2020 | N/A | No |
70795-1120-4 | 100 TABLET in 1 BOTTLE (70795-1120-4) | 16 Nov, 2020 | 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. |
Purpose:
Purpose electrolyte replenisher
Product Elements:
Normal salt sodium chloride powdered cellulose sodium chloride chloride ion g13
Indications and Usage:
Uses for the preparation of normal isotonic solution of sodium chloride as an electrolyte replenisher for the prevention of heat cramps due to excessive perspiration any alternative use as directed by a physician
Warnings:
Warnings enter section text here do not use without consulting a physician ask a physician before use if you have a sodium restricted diet due to multiple organ diseases stop use and ask a physician if symptoms of heat cramps continue for more than 24 hours if pregnant or breast-feeding ask a health professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away
Do Not Use:
Warnings enter section text here do not use without consulting a physician ask a physician before use if you have a sodium restricted diet due to multiple organ diseases stop use and ask a physician if symptoms of heat cramps continue for more than 24 hours if pregnant or breast-feeding ask a health professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away
Dosage and Administration:
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
Stop Use:
Stop use and ask a physician if symptoms of heat cramps continue for more than 24 hours
Use in Pregnancy:
If pregnant or breast-feeding ask a health professional before use.
Package Label Principal Display Panel:
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