| Drug NDC: | 63479-0207 |
| 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: | B07 Dprsn Antitox |
| Also known as the trade name. It is the name of the product chosen by the labeler. | |
| Proprietary Name Base: | B07 |
| The base of the Brand/Proprietary name excluding its suffix. | |
| Proprietary Name Suffix: | DPRSN ANTITOX |
| 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: | Adrenalinum, Aethusa Cynapium, Agnus Castus, Alfalfa, Argentum Nitricum, Aurum Metallicum, Avena Sativa, Ceratostigma Willmottianum Flower, Cherry Plum Flower, Damiana, European Aspen Flower, European Hornbeam Flower, Gorse Flower, Hypericum Perforatum, Kali Phosphoricum, Lycopodium Clavatum, Mandragora Officinarum, Natrum Muriaticum, Passiflora Incarnata, Rosa Canina Flower, Sepia, Sweet Chestnut Flower, Thyroidinum, Wild Mustard Flower |
| 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: | AETHUSA CYNAPIUM - 30 [hp_X]/mL ALFALFA - 1 [hp_X]/mL AVENA SATIVA FLOWERING TOP - 1 [hp_X]/mL CARPINUS BETULUS FLOWER - 15 [hp_X]/mL CASTANEA SATIVA FLOWER - 15 [hp_X]/mL CERATOSTIGMA WILLMOTTIANUM FLOWER - 30 [hp_X]/mL CHASTE TREE - 2 [hp_X]/mL EPINEPHRINE - 6 [hp_X]/mL GOLD - 30 [hp_X]/mL HYPERICUM PERFORATUM - 3 [hp_X]/mL Load more... LYCOPODIUM CLAVATUM SPORE - 60 [hp_X]/mL MANDRAGORA OFFICINARUM ROOT - 30 [hp_X]/mL PASSIFLORA INCARNATA FLOWERING TOP - 1 [hp_X]/mL POPULUS TREMULA FLOWERING TOP - 30 [hp_X]/mL POTASSIUM PHOSPHATE, DIBASIC - 30 [hp_X]/mL PRUNUS CERASIFERA FLOWER - 15 [hp_X]/mL ROSA CANINA FLOWER - 15 [hp_X]/mL SEPIA OFFICINALIS JUICE - 30 [hp_X]/mL SILVER NITRATE - 30 [hp_X]/mL SINAPIS ARVENSIS FLOWERING/FRUITING TOP - 15 [hp_X]/mL SODIUM CHLORIDE - 30 [hp_X]/mL THYROID, UNSPECIFIED - 6 [hp_X]/mL TURNERA DIFFUSA LEAFY TWIG - 1 [hp_X]/mL ULEX EUROPAEUS FLOWER - 30 [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 Jul, 1997 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 20 Dec, 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. | |
| 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. | |
| NUI: | N0000000209 N0000000245 N0000175552 N0000175555 N0000175570 M0003647 N0000185508 N0000175629 N0000184306 M0000728 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | M6936L953C DJO934BRBD MA9CQJ3F7F 07YL55QKZ9 YHZ719F7M3 TP69J995TW 433OSF3U8A YKH834O4BH 79Y1949PYO XK4IUX8MNB Load more... C88X29Y479 I2XCB174VB CLF5YFS11O 5Q01F7TPJJ CI71S98N1Z 0KD7R09EAS 81MCR2UQ6Q QDL83WN8C2 95IT3W8JZE WWX61E1ZAK 451W47IQ8X 0B4FDL9I6P RQ2CFA7WWJ 398DBS1PXN |
| 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 MOA: | Adrenergic alpha-Agonists [MoA] Adrenergic beta-Agonists [MoA] |
| Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`. | |
| Pharmacologic Class EPC: | alpha-Adrenergic Agonist [EPC] beta-Adrenergic Agonist [EPC] Catecholamine [EPC] Standardized Chemical Allergen [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: | Catecholamines [CS] Allergens [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: | Adrenergic alpha-Agonists [MoA] Adrenergic beta-Agonists [MoA] Allergens [CS] Catecholamine [EPC] Catecholamines [CS] Cell-mediated Immunity [PE] Increased Histamine Release [PE] Increased Large Intestinal Motility [PE] Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] Osmotic Activity [MoA] Osmotic Laxative [EPC] Potassium Compounds [CS] Potassium Salt [EPC] Standardized Chemical Allergen [EPC] alpha-Adrenergic Agonist [EPC] beta-Adrenergic Agonist [EPC] |
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. | |
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|---|---|---|---|
| 63479-0207-1 | 30 mL in 1 BOTTLE, GLASS (63479-0207-1) | 15 Jul, 1997 | 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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