Formiplus
Artemisia Abrotanum Flowering Top And Formic Acid
Pekana Naturheilmittel Gmbh
Human Otc Drug
NDC 59469-047Formiplus also known as Artemisia Abrotanum Flowering Top And Formic Acid is a human otc drug labeled by 'Pekana Naturheilmittel Gmbh'. National Drug Code (NDC) number for Formiplus is 59469-047. This drug is available in dosage form of Solution/ Drops. The names of the active, medicinal ingredients in Formiplus drug includes Artemisia Abrotanum Flowering Top - 4 [hp_X]/100mL Formic Acid - 200 [hp_X]/100mL . The currest status of Formiplus drug is Active.
Drug Information:
| Drug NDC: | 59469-047 |
| 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: | Formiplus |
| 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: | Artemisia Abrotanum Flowering Top And Formic Acid |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Pekana Naturheilmittel Gmbh |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Solution/ Drops |
| 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: | ARTEMISIA ABROTANUM FLOWERING TOP - 4 [hp_X]/100mL
FORMIC ACID - 200 [hp_X]/100mL
|
| 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 HOMEOPATHIC |
| 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: | 12 Apr, 2008 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 16 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: | PEKANA Naturheilmittel GmbH
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | QG07G580U0
0YIW783RG1
|
| 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 |
|---|
| 59469-047-30 | 1 BOTTLE, GLASS in 1 BOX (59469-047-30) / 100 mL in 1 BOTTLE, GLASS | 12 Apr, 2008 | 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:
For relief of occasional listlessness. application of this homeopathic remedy for the designated usage is exclusively based on homeopathic experience. with severe forms of this disease, a clinically proven therapy is indicated.
Product Elements:
Formiplus artemisia abrotanum flowering top and formic acid artemisia abrotanum flowering top artemisia abrotanum flowering top formic acid formic acid water alcohol
Indications and Usage:
Indications for relief of occasional listlessness. application of this homeopathic remedy for the designated usage is exclusively based on homeopathic experience. with severe forms of this disease, a clinically proven therapy is indicated.
Warnings:
Warning if symptoms persist, contact a licensed practitioner. if you have known sensitivity to any of the ingredients, please consult your licensed practitioner before use. if you are pregnant or nursing a baby, seek the advice of a health care professional before use. keep out of the reach of children. protect from light and heat. tamper evident do not use this product if tamper evident strip is broken or removed from base of cap.
Dosage and Administration:
Dosage unless otherwise prescribed, adults take 15-20 drops, 3 times per day. for pediatric dosages, consult your practitioner.
Package Label Principal Display Panel:
Principal display panel - 100 ml bottle box formiplus⢠oral drops homeopathic medicine for relief of occasional listlessness 3.34 fl oz (100 ml) pekana ® principal display panel - 100 ml bottle box
Further Questions:
To report adverse events, contact bioresource at 321b blodgett street, cotati, ca 94931