Arnica Montana
Vitamedica Corporation
Human Otc Drug
NDC 65111-005Arnica Montana is a human otc drug labeled by 'Vitamedica Corporation'. National Drug Code (NDC) number for Arnica Montana is 65111-005. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Arnica Montana drug includes Arnica Montana - 30 [hp_X]/1 . The currest status of Arnica Montana drug is Active.
Drug Information:
| Drug NDC: | 65111-005 |
| 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: | Arnica Montana |
| 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: | Arnica Montana |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Vitamedica Corporation |
| 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: | ARNICA MONTANA - 30 [hp_X]/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 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 Aug, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 22 Sep, 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: | 15 Jan, 2025 |
| 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: | Vitamedica Corporation
|
| 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: | O80TY208ZW
|
| 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 |
|---|
| 65111-005-67 | 150 TABLET in 1 BOTTLE (65111-005-67) | 12 Aug, 2021 | 22 Sep, 2026 | 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: anti-inflammatory
Product Elements:
Arnica montana arnica montana arnica montana arnica montana copovidone k25-31 crospovidone lactose monohydrate magnesium stearate mannitol cellulose, microcrystalline silicon dioxide sorbitol tablet v
Indications and Usage:
Indication: anti-inflammatory
Warnings:
Warnings: if pregnant or breast-feeding ask a health professional before use. discontinue use if any adverse reactions occur. contact your physician, if symptoms do not subside within 14 days. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away. do not use if seal is broken or shows any signs of tampering.
Dosage and Administration:
Directions: adults, three tablets, three times a day. not intended for children under 12 years of age. this product is a sublingual application.
Package Label Principal Display Panel:
Package display label vitamedica arnica montana 30x hpus reduces bruising, swelling & pain natural remedy stimulates healing recommended by plastic surgeons homeopathic medicine 150 sublingual tablets arnica montana 30x hpus
Further Questions:
Questions: formulated and distributed by vitamedica corp. torrance, ca 90502 888-367-8605 vitamedica.com ©2021 vitamedica corporation ndc 65111-005-67