Belladonna
Rxhomeo Private Limited D.b.a. Rxhomeo, Inc
Human Otc Drug
NDC 15631-0076Belladonna is a human otc drug labeled by 'Rxhomeo Private Limited D.b.a. Rxhomeo, Inc'. National Drug Code (NDC) number for Belladonna is 15631-0076. This drug is available in dosage form of Pellet. The names of the active, medicinal ingredients in Belladonna drug includes Atropa Belladonna - 3 [hp_X]/1 . The currest status of Belladonna drug is Active.
Drug Information:
| Drug NDC: | 15631-0076 |
| 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: | Belladonna |
| 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: | Belladonna |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Rxhomeo Private Limited D.b.a. Rxhomeo, Inc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Pellet |
| 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: | ATROPA BELLADONNA - 3 [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: | 03 Sep, 2015 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 15 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. |
| 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: | Rxhomeo Private Limited d.b.a. Rxhomeo, Inc
|
| 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. |
| UPC: | 8907460005526
|
| UPC stands for Universal Product Code. |
| UNII: | WQZ3G9PF0H
|
| 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 |
|---|
| 15631-0076-0 | 100 PELLET in 1 PACKAGE (15631-0076-0) | 01 Jan, 2018 | N/A | No |
| 15631-0076-1 | 200 PELLET in 1 PACKAGE (15631-0076-1) | 01 Jan, 2018 | N/A | No |
| 15631-0076-2 | 400 PELLET in 1 PACKAGE (15631-0076-2) | 01 Jan, 2018 | N/A | No |
| 15631-0076-3 | 750 PELLET in 1 PACKAGE (15631-0076-3) | 01 Jan, 2018 | N/A | No |
| 15631-0076-4 | 2500 PELLET in 1 PACKAGE (15631-0076-4) | 01 Jan, 2018 | N/A | No |
| 15631-0076-5 | 12500 PELLET in 1 PACKAGE (15631-0076-5) | 01 Jan, 2018 | N/A | No |
| 15631-0076-6 | 500 PELLET in 1 PACKAGE (15631-0076-6) | 23 Aug, 2021 | N/A | No |
| 15631-0076-7 | 1000 PELLET in 1 PACKAGE (15631-0076-7) | 23 Aug, 2021 | 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:
Uses uses: temporary relief - fever, pain* * claims based on traditional homeopathic practice, not accepted medical evidence. not fda evaluated.
Product Elements:
Belladonna belladonna sucrose atropa belladonna atropa belladonna
Indications and Usage:
Indications condition listed above or as directed by the physician
Warnings:
Warnings this product is to be used for self-limiting conditions if symptoms do not improve in 4 days, or worsen, discontinue use and seek assistance of health professional as with any drug, if you are preganant, or nursing a baby, seek professional advice before taking this product keep this and all medication out of reach of children do not use if capseal is broken or missing. close the cap tightly after use.
Do Not Use:
Warnings this product is to be used for self-limiting conditions if symptoms do not improve in 4 days, or worsen, discontinue use and seek assistance of health professional as with any drug, if you are preganant, or nursing a baby, seek professional advice before taking this product keep this and all medication out of reach of children do not use if capseal is broken or missing. close the cap tightly after use.
Dosage and Administration:
Dosage adults- take 4 or 6 pellets by mouth, three times daily or as suggested by physician. children 2 years and older- take 1/2 the adult dose.
Stop Use:
If symptoms do not improve in 4 days, or worsen, discontinue use and seek assistance of health professional
Package Label Principal Display Panel:
Mini-label label-pellets blister-pack carton-pack
Further Questions:
Questions or comments www.rxhomeo.com | 1.888.2796642 | info@rxhomeo.com rxhomeo, inc 3200 commander dr, ste 100-w1, carrollton, tx 75006 usa