Humco Strong Iodine
Iodine And Potassium Iodide
Humco Holding Group, Inc.
Human Prescription Drug
NDC 0395-2775Humco Strong Iodine also known as Iodine And Potassium Iodide is a human prescription drug labeled by 'Humco Holding Group, Inc.'. National Drug Code (NDC) number for Humco Strong Iodine is 0395-2775. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Humco Strong Iodine drug includes Iodine - 50 mg/mL Potassium Iodide - 100 mg/mL . The currest status of Humco Strong Iodine drug is Active.
Drug Information:
| Drug NDC: | 0395-2775 |
| 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: | Humco Strong Iodine |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription 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: | Iodine And Potassium Iodide |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Humco Holding Group, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Liquid |
| 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: | IODINE - 50 mg/mL
POTASSIUM IODIDE - 100 mg/mL
|
| 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: | 01 Jan, 2008 |
| 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: | Humco Holding Group, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 204913
|
| 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: | 9679TC07X4
1C4QK22F9J
|
| 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 |
|---|
| 0395-2775-16 | 473 mL in 1 BOTTLE, PLASTIC (0395-2775-16) | 14 Nov, 2017 | 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 iodine supplement
Product Elements:
Humco strong iodine iodine and potassium iodide water iodine iodine potassium iodide iodide ion
Indications and Usage:
Use source of iodne indictaions: this product has several uses where iodine is indicated. this product may be used in the treatment of hyperthyroidism in the immediate preoperative period in preparation for thyroidectomy. it may be used alone, but more frequently is used after the hyperthyroidism is controlled by an antithyroid drug. it is given during the 10 days immediately prior to the operation. optimal control of hyperthyroidism is achieved if antithyroid drugs are first given alone. this product is also used in thyrotoxicosis crisis in conjunction with supportive measures to control fever and adequate fluid intake.
Warnings:
Warnings warning: large doseage may cause iodine poisoning.
Warnings vesication and desquamation may occur if allowed to pool in contact with the skin. excess iodine should be removed with alcohol to prevent "iodine burns."
General Precautions:
Caution to physician: read the following indications, side effects, precautions and caotraindications as a reminder in evaluating each case for supplemental iodine.
Dosage and Administration:
Directions: dosage: usual dose; 4-1/2 minimis 3 times daily. dilute with water or juie. ususal dose range: 1-1/2 to 15 minims daily.
Contraindications:
Contraindications: iodine should not be given to cases of active tuberculosis, or those known to be sensitive to iodine, and discontinued in cases later developing a sensitivity to the iodine therapy.
Package Label Principal Display Panel:
Lugols