| Drug NDC: | 64578-0159 |
| 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: | Gb-tone |
| 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: | Ammi Vis, Atropinum Sulphuricum, Boldo, Carduus Mar, Chelidonium Maj, Echinacea, Fel Tauri, Hepar Suis, Hydrastis, Leptandra, Mag Phos, Nat Phos, Podoph Pelt, Taraxacum |
| Also known as the generic name, this is usually the active ingredient(s) of the product. | |
| Labeler Name: | Energetix Corporation |
| 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: | ATROPINE SULFATE - 12 [hp_X]/59.1mL BOS TAURUS BILE - 8 [hp_X]/59.1mL CHELIDONIUM MAJUS - 12 [hp_X]/59.1mL ECHINACEA, UNSPECIFIED - 4 [hp_X]/59.1mL GOLDENSEAL - 5 [hp_X]/59.1mL MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE - 12 [hp_X]/59.1mL MILK THISTLE - 4 [hp_X]/59.1mL PEUMUS BOLDUS LEAF - 4 [hp_X]/59.1mL PODOPHYLLUM - 12 [hp_X]/59.1mL PORK LIVER - 9 [hp_X]/59.1mL Load more... SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE - 6 [hp_X]/59.1mL TARAXACUM OFFICINALE - 4 [hp_X]/59.1mL VERONICASTRUM VIRGINICUM ROOT - 12 [hp_X]/59.1mL VISNAGA DAUCOIDES FRUIT - 12 [hp_X]/59.1mL |
| 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 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: | 01 Jan, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 06 May, 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. | |
| Manufacturer Name: | Energetix 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: | 03J5ZE7KA5 ET3651ZLOU 7E889U5RNN 4N9P6CC1DX ZW3Z11D0JV HF539G9L3Q U946SH95EE Q4EWM09M3O 2S713A4VP3 6EC706HI7F Load more... 70WT22SF4B 39981FM375 M2O62YTN42 3UN285QN0C |
| 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. | |
| Pharmacologic Class: | Anticholinergic [EPC] Calculi Dissolution Agent [EPC] Cholinergic Antagonists [MoA] Cholinergic Muscarinic Antagonist [EPC] Cholinergic Muscarinic Antagonists [MoA] Increased Large Intestinal Motility [PE] Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] Inhibition Small Intestine Fluid/Electrolyte Absorption [PE] Magnesium Ion Exchange Activity [MoA] Osmotic Activity [MoA] Osmotic Laxative [EPC] Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] |
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. | |
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|---|---|---|---|
| 64578-0159-1 | 59.1 mL in 1 BOTTLE (64578-0159-1) | 01 Jan, 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. | ||||
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