Insadol
Corn Sterilized Quantitative Extract (beta Sitosterol)
I World Pharmaceutical Co., Ltd.
Human Otc Drug
NDC 73442-0002Insadol also known as Corn Sterilized Quantitative Extract (beta Sitosterol) is a human otc drug labeled by 'I World Pharmaceutical Co., Ltd.'. National Drug Code (NDC) number for Insadol is 73442-0002. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Insadol drug includes .beta.-sitosterol - 35 mg/1 . The currest status of Insadol drug is Active.
Drug Information:
| Drug NDC: | 73442-0002 |
| 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: | Insadol |
| 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: | Corn Sterilized Quantitative Extract (beta Sitosterol) |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | I World Pharmaceutical Co., Ltd. |
| 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: | .BETA.-SITOSTEROL - 35 mg/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: | UNAPPROVED DRUG OTHER |
| 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: | 08 Oct, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 19 Jun, 2026 |
| 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. |
| 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: | I World Pharmaceutical Co., Ltd.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 2104173
|
| 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: | S347WMO6M4
|
| 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 |
|---|
| 73442-0002-1 | 100 TABLET in 1 BLISTER PACK (73442-0002-1) | 08 Oct, 2019 | 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:
Periodontal disease [dental caries disease, gingivitis, periodontitis (periodontal periodontitis)]
Product Elements:
Insadol corn sterilized quantitative extract (beta sitosterol) povidone k30 sodium starch glycolate type a corn powdered cellulose magnesium stearate .beta.-sitosterol .beta.-sitosterol isd
Indications and Usage:
â adult: two tablets once, three times a day before meal â as a maintenance dose, one tablet once, three times a day before meal
Warnings:
Do not take this medicine if â people who are hypersensitive to the drugs and ingredients contained in this medicine consult a doctor, dentist, or pharmacist before taking this medicine â patients who are overreacting to substrates of azoic pigment, acetyl salicylic acid or other prostaglandin syncase inhibitors should be careful about the use of this drug â be careful because this drug may interfere with the absorption of cholesterol medicines. â pregnancy and lactation (for pregnant women or wives who are likely to be pregnant, only if the therapeutic benefit exceeds the risk) â since this drug contains yellow 4 (tartrazine), consult a doctor, dentist, or pharmacist before taking it (for that item only) immediately stop taking this medicine and consult a doctor or pharmacist if: â the drug is administered to patients with asthma or chronic stomatosis or is overreacting to non-steroidal anti-inflammatory drugs, it may cause anaphylaxis or respiratory syst
Read more...em to overreact
Dosage and Administration:
For oral use only
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