| Drug NDC: | 63479-1405 |
| 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: | N05 Lymphotox |
| Also known as the trade name. It is the name of the product chosen by the labeler. | |
| Proprietary Name Base: | N05 |
| The base of the Brand/Proprietary name excluding its suffix. | |
| Proprietary Name Suffix: | LYMPHOTOX |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. | |
| 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: | Aranea Diadema, Arnica Montana, Asterias Rubens, Baryta Iodata, Carbo Vegetabilis, Ceanothus Americanus, Echinacea Angustifolia, Echinacea Purpurea, Equisetum Hyemale, Ferrum Iodatum, Glycyrrhiza Glabra, Hydrastis Canadensis, Lachesis Mutus, Mercurous Iodide, Millefolium, Natrum Sulphuricum, Phytolacca Decandra, Pinus Sylvestris Flower, Scrophularia Nodosa, Sulphur Iodatum, Teucrium Scorodonia, Veronica Beccabunga |
| Also known as the generic name, this is usually the active ingredient(s) of the product. | |
| Labeler Name: | Apex Energetics Inc. |
| 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: | ACHILLEA MILLEFOLIUM - 1 [hp_X]/mL ACTIVATED CHARCOAL - 30 [hp_X]/mL ARANEUS DIADEMATUS - 12 [hp_X]/mL ARNICA MONTANA - 3 [hp_X]/mL ASTERIAS RUBENS - 10 [hp_X]/mL BARIUM IODIDE - 20 [hp_X]/mL CEANOTHUS AMERICANUS LEAF - 1 [hp_X]/mL ECHINACEA ANGUSTIFOLIA - 1 [hp_X]/mL ECHINACEA PURPUREA - 1 [hp_X]/mL EQUISETUM HYEMALE - 12 [hp_X]/mL Load more... FERROUS IODIDE - 15 [hp_X]/mL GLYCYRRHIZA GLABRA - 1 [hp_X]/mL GOLDENSEAL - 9 [hp_X]/mL LACHESIS MUTA VENOM - 15 [hp_X]/mL MERCUROUS IODIDE - 9 [hp_X]/mL PHYTOLACCA AMERICANA ROOT - 12 [hp_X]/mL PINUS SYLVESTRIS FLOWERING TOP - 12 [hp_X]/mL SCROPHULARIA NODOSA - 15 [hp_X]/mL SODIUM SULFATE - 12 [hp_X]/mL SULFUR IODIDE - 30 [hp_X]/mL TEUCRIUM SCORODONIA FLOWERING TOP - 12 [hp_X]/mL VERONICA BECCABUNGA - 9 [hp_X]/mL |
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. | |
| Route Details: | SUBLINGUAL |
| 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: | 15 Dec, 1994 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 13 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: | Apex Energetics 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: | 0818960013004 |
| UPC stands for Universal Product Code. | |
| NUI: | N0000185371 N0000185375 N0000175629 N0000184306 M0000728 M0006342 M0016962 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | 2FXJ6SW4PK 2P3VWU3H10 6T6CO7R3Z5 O80TY208ZW A7FYY9Q742 WKC4T7680A 25B1Y14T8N VB06AV5US8 QI7G114Y98 59677RXH25 Load more... F5452U54PN 2788Z9758H ZW3Z11D0JV VSW71SS07I HT0935F2JR 11E6VI8VEG 2HEM73YI9I 7H443NUB2T 0YPR65R21J L6L8KA2AA0 LOK3I16O7G 4989JW6TRZ |
| 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 Food Allergenic Extract [EPC] Non-Standardized Plant 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] |
| 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: | Allergens [CS] Dietary Proteins [CS] Plant Proteins [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] Increased Histamine Release [PE] Non-Standardized Food 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 |
|---|---|---|---|---|
| 63479-1405-1 | 30 mL in 1 BOTTLE, GLASS (63479-1405-1) | 15 Dec, 1994 | 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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