| Drug NDC: | 63479-0102 |
| 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: | A02 Gentle Drainage |
| Also known as the trade name. It is the name of the product chosen by the labeler. | |
| Proprietary Name Base: | A02 |
| The base of the Brand/Proprietary name excluding its suffix. | |
| Proprietary Name Suffix: | GENTLE DRAINAGE |
| 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: | Alfalfa, Allium Sativum, American Ginseng, Asparagus Officinalis, Avena Sativa, Berberis Vulgaris, Bos Taurus Adrenal Gland, Colon, Kidney, Liver, Lymph Vessel, Pancreas, Calcarea Phosphorica, Carbo Vegetabilis, Crab Apple Flower, European Hornbeam Flower, Gentiana Lutea, Histaminum Hydrochloricum, Juniperus Communis Stem, Lacticum Acidum, Passiflora Incarnata, Phosphorus, Ribes Nigrum Flower Bud, Scrophularia Nodosa, Solidago Virgaurea |
| 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: | ACTIVATED CHARCOAL - 15 [hp_X]/mL ALFALFA - 6 [hp_X]/mL AMERICAN GINSENG - 9 [hp_X]/mL ASPARAGUS - 9 [hp_X]/mL AVENA SATIVA FLOWERING TOP - 6 [hp_X]/mL BEEF KIDNEY - 7 [hp_C]/mL BEEF LIVER - 7 [hp_C]/mL BERBERIS VULGARIS ROOT BARK - 12 [hp_X]/mL BOS TAURUS ADRENAL GLAND - 7 [hp_C]/mL BOS TAURUS COLON - 7 [hp_C]/mL Load more... BOS TAURUS LYMPH VESSEL - 7 [hp_C]/mL BOS TAURUS PANCREAS - 7 [hp_C]/mL CARPINUS BETULUS FLOWER - 12 [hp_X]/mL GARLIC - 9 [hp_X]/mL GENTIANA LUTEA ROOT - 6 [hp_X]/mL HISTAMINE DIHYDROCHLORIDE - 6 [hp_C]/mL JUNIPERUS COMMUNIS STEM - 8 [hp_X]/mL LACTIC ACID, DL- - 12 [hp_X]/mL MALUS SYLVESTRIS FLOWER - 12 [hp_X]/mL PASSIFLORA INCARNATA FLOWERING TOP - 9 [hp_X]/mL PHOSPHORUS - 12 [hp_X]/mL RIBES NIGRUM FLOWER BUD - 6 [hp_X]/mL SCROPHULARIA NODOSA - 10 [hp_X]/mL SOLIDAGO VIRGAUREA FLOWERING TOP - 9 [hp_X]/mL TRIBASIC CALCIUM PHOSPHATE - 15 [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 Aug, 1988 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 22 Jun, 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. | |
| NUI: | N0000185371 N0000175629 N0000184306 M0000728 M0006342 M0022575 N0000185017 M0016962 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | 2P3VWU3H10 DJO934BRBD 8W75VCV53Q Z1EJP3037Z MA9CQJ3F7F 5HOC10FSIC W8N8R55022 1TH8Q20J0U M2776SWB29 8PD5L21RYS Load more... 85I1Z426OV 1M529TNT1D 07YL55QKZ9 V1V998DC17 S72O3284MS 3POA0Q644U HBU87MH6OY 3B8D35Y7S4 6ZJ8N1924Z CLF5YFS11O 27YLU75U4W VYH9Y9BCCP 7H443NUB2T 5405K23S50 91D9GV0Z28 |
| 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] |
| 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] Vegetable 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] Meat Proteins [EXT] Non-Standardized Food Allergenic Extract [EPC] Plant Proteins [CS] Vegetable 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 |
|---|---|---|---|---|
| 63479-0102-1 | 30 mL in 1 BOTTLE, GLASS (63479-0102-1) | 15 Aug, 1988 | 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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