| Drug NDC: | 64578-0158 |
| 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: | Bacteria-chord |
| 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: | Azadirachta, Belladonna, Berber Vulg, Boldo, Candida Alb, Ceanothus, Cetraria, Crotalus Hor , Echinacea, Glandula Suprarenalis Suis, Glycyrrhiza, Hamamelis, Hepar Suis, Hydrastis, Hydrocotyle, Hypericum, Lappa, Ledum, Millefolium, Morbillinum, Myrrha, Pancreas, Pertussinum, Phos, Plantago, Pyrogenium, Solidago, Zingiber |
| 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: | ACHILLEA MILLEFOLIUM WHOLE - 12 [hp_X]/59.1mL ARCTIUM LAPPA ROOT - 4 [hp_X]/59.1mL ATROPA BELLADONNA - 8 [hp_X]/59.1mL AZADIRACHTA INDICA BARK - 8 [hp_X]/59.1mL BERBERIS VULGARIS ROOT BARK - 9 [hp_X]/59.1mL CANDIDA ALBICANS - 30 [hp_X]/59.1mL CEANOTHUS AMERICANUS LEAF - 4 [hp_X]/59.1mL CENTELLA ASIATICA - 6 [hp_X]/59.1mL CETRARIA ISLANDICA WHOLE - 12 [hp_X]/59.1mL CROTALUS HORRIDUS HORRIDUS VENOM - 12 [hp_X]/59.1mL Load more... ECHINACEA, UNSPECIFIED - 4 [hp_X]/59.1mL GINGER - 6 [hp_X]/59.1mL GLYCYRRHIZA GLABRA - 4 [hp_X]/59.1mL GOLDENSEAL - 5 [hp_X]/59.1mL HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - 6 [hp_X]/59.1mL HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED - 30 [hp_X]/59.1mL HYPERICUM PERFORATUM WHOLE - 12 [hp_X]/59.1mL MEASLES VIRUS - 30 [hp_X]/59.1mL MYRRH - 4 [hp_X]/59.1mL PEUMUS BOLDUS LEAF - 4 [hp_X]/59.1mL PHOSPHORUS - 12 [hp_X]/59.1mL PLANTAGO MAJOR - 4 [hp_X]/59.1mL PORK LIVER - 9 [hp_X]/59.1mL RANCID BEEF - 30 [hp_X]/59.1mL RHODODENDRON TOMENTOSUM LEAFY TWIG - 9 [hp_X]/59.1mL SOLIDAGO VIRGAUREA FLOWERING TOP - 4 [hp_X]/59.1mL SUS SCROFA ADRENAL GLAND - 9 [hp_X]/59.1mL SUS SCROFA PANCREAS - 9 [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: | 09 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. | |
| NUI: | N0000185372 N0000175629 N0000184306 N0000185001 M0008890 M0000728 N0000185375 N0000185371 M0006342 M0016962 M0008672 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | 2FXJ6SW4PK 597E9BI3Z3 WQZ3G9PF0H G580B439YI 1TH8Q20J0U 4D7G21HDBC 25B1Y14T8N 7M867G6T1U BJ7YPN79A1 YHA2XLJ956 Load more... 4N9P6CC1DX C5529G5JPQ 2788Z9758H ZW3Z11D0JV T7S323PKJS U364V64HUN XK4IUX8MNB HT3R7C012Q JC71GJ1F3L Q4EWM09M3O 27YLU75U4W W2469WNO6U 6EC706HI7F 29SUH5R3HU 877L01IZ0P 5405K23S50 398IYQ16YV 9Y3J3362RY |
| 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 EPC: | Non-Standardized Fungal Allergenic Extract [EPC] Non-Standardized Plant Allergenic Extract [EPC] Non-Standardized Food Allergenic Extract [EPC] |
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. | |
| Pharmacologic Class PE: | Increased Histamine Release [PE] Cell-mediated Immunity [PE] Increased IgG Production [PE] |
| Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`. | |
| Pharmacologic Class CS: | Fungal Proteins [CS] Allergens [CS] Dietary Proteins [CS] Plant Proteins [CS] Food Additives [CS] |
| Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient]. | |
| Pharmacologic Class: | Allergens [CS] Cell-mediated Immunity [PE] Dietary Proteins [CS] Food Additives [CS] Fungal Proteins [CS] Increased Histamine Release [PE] Increased IgG Production [PE] Non-Standardized Food Allergenic Extract [EPC] Non-Standardized Fungal Allergenic Extract [EPC] Non-Standardized Plant Allergenic Extract [EPC] Plant Proteins [CS] |
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. | |
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|---|---|---|---|
| 64578-0158-1 | 59.1 mL in 1 BOTTLE (64578-0158-1) | 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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