| Drug NDC: | 63479-0627 |
| 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: | F27 Mvon |
| Also known as the trade name. It is the name of the product chosen by the labeler. | |
| Proprietary Name Base: | F27 |
| The base of the Brand/Proprietary name excluding its suffix. | |
| Proprietary Name Suffix: | MVON |
| 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: | Agrimony, Arnica Montana, Arsenicum Album, Artemisia Tridentata, Aspen, Chamomile, Chicory, Dicentra Formosa, Ehrendorferia Chrysantha, Eucalyptus Globulus, Hardy Fuchsia, Horse Chestnut, Ignatia Amara, Juglans Regia, Lachesis Mutus, Larix Decidua, Mimulus Guttatus, Mountain Dogwood, Natrum Muriaticum, Palladium, Perfoliate Honeysuckle, Petunia Axillaris, Pulsatilla Vulgaris, Pyrenees Star Of Bethlehem, Scotch Broom, Trillium Chloropetalum, Yellow Jasmine, Yerba Santa, Zinnia Elegans |
| 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: | AESCULUS CARNEA FLOWER - 12 [hp_C]/mL AESCULUS HIPPOCASTANUM FLOWER - 12 [hp_C]/mL AGRIMONIA EUPATORIA FLOWER - 12 [hp_C]/mL ARNICA MONTANA - 15 [hp_C]/mL ARNICA MONTANA FLOWER - 12 [hp_C]/mL ARSENIC TRIOXIDE - 7 [hp_C]/mL ARTEMISIA TRIDENTATA WHOLE - 12 [hp_C]/mL CICHORIUM INTYBUS FLOWER - 12 [hp_C]/mL CORNUS NUTTALLII WHOLE - 12 [hp_C]/mL CYTISUS SCOPARIUS FLOWER - 12 [hp_C]/mL Load more... DICENTRA FORMOSA WHOLE - 12 [hp_C]/mL EHRENDORFERIA CHRYSANTHA WHOLE - 12 [hp_C]/mL ERIODICTYON CALIFORNICUM FLOWERING TOP - 12 [hp_C]/mL EUCALYPTUS GLOBULUS LEAF - 12 [hp_C]/mL FUCHSIA MAGELLANICA WHOLE - 12 [hp_C]/mL GELSEMIUM SEMPERVIRENS ROOT - 12 [hp_C]/mL JUGLANS REGIA FLOWERING TOP - 12 [hp_C]/mL LACHESIS MUTA VENOM - 20 [hp_C]/mL LARIX DECIDUA FLOWERING TOP - 12 [hp_C]/mL LONICERA CAPRIFOLIUM FLOWER - 12 [hp_C]/mL MATRICARIA CHAMOMILLA FLOWERING TOP - 15 [hp_C]/mL MIMULUS GUTTATUS FLOWERING TOP - 12 [hp_C]/mL ORNITHOGALUM UMBELLATUM FLOWERING TOP - 12 [hp_C]/mL PALLADIUM - 15 [hp_C]/mL PETUNIA AXILLARIS WHOLE - 12 [hp_C]/mL POPULUS TREMULA FLOWERING TOP - 12 [hp_C]/mL PULSATILLA VULGARIS - 15 [hp_C]/mL SODIUM CHLORIDE - 20 [hp_C]/mL STRYCHNOS IGNATII SEED - 20 [hp_C]/mL TRILLIUM CHLOROPETALUM WHOLE - 12 [hp_C]/mL ZINNIA ELEGANS WHOLE - 12 [hp_C]/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: | 12 Mar, 1996 |
| 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: | 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: | 0818960012007 |
| UPC stands for Universal Product Code. | |
| UNII: | 717DPT98VM KK0Z92II8M 5811MI029U O80TY208ZW OZ0E5Y15PZ S7V92P67HO 45E08M336T HW54500A89 F34859WS62 205JZ3JIKD Load more... 6OFG7K362R 68HKD4QMJR HKE3DK7994 S546YLW6E6 J66MJH220L 639KR60Q1Q 3BA2N709NG VSW71SS07I 9UMZ642257 5N1WD9784U 3VNC7T6Z02 192426I5JU CZD6M4PY4B 5TWQ1V240M B7U2BWH3OT 5Q01F7TPJJ I76KB35JEV 451W47IQ8X 1NM3M2487K 2AHE793C13 70TF95C8U7 |
| 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: | Increased Large Intestinal Motility [PE] Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] Osmotic Activity [MoA] Osmotic Laxative [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 |
|---|---|---|---|---|
| 63479-0627-1 | 30 mL in 1 BOTTLE, GLASS (63479-0627-1) | 12 Mar, 1996 | 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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