| Drug NDC: | 63479-0625 |
| 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: | F25 Lf-chngs |
| Also known as the trade name. It is the name of the product chosen by the labeler. | |
| Proprietary Name Base: | F25 |
| The base of the Brand/Proprietary name excluding its suffix. | |
| Proprietary Name Suffix: | LF-CHNGS |
| 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 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: | AESCULUS HIPPOCASTANUM FLOWER - 12 [hp_C]/mL AGRIMONIA EUPATORIA FLOWER - 12 [hp_C]/mL ARNICA MONTANA FLOWER - 12 [hp_C]/mL ARSENIC TRIOXIDE - 30 [hp_C]/mL ARTEMISIA TRIDENTATA WHOLE - 12 [hp_C]/mL CALLUNA VULGARIS FLOWERING TOP - 12 [hp_C]/mL CALOCHORTUS TOLMIEI WHOLE - 12 [hp_C]/mL CAPSICUM - 12 [hp_C]/mL DIEFFENBACHIA SEGUINE - 4 [hp_X]/mL ESCHSCHOLZIA CALIFORNICA FLOWER - 12 [hp_C]/mL Load more... FAGUS SYLVATICA FLOWERING TOP - 12 [hp_C]/mL GOSSYPIUM HERBACEUM FLOWER - 12 [hp_C]/mL HELIANTHUS ANNUUS FLOWERING TOP - 12 [hp_C]/mL HYLOTELEPHIUM TELEPHIUM WHOLE - 12 [hp_C]/mL IPOMOEA PURPUREA TOP - 12 [hp_C]/mL JUGLANS REGIA FLOWERING TOP - 12 [hp_C]/mL LACHESIS MUTA VENOM - 30 [hp_C]/mL LARREA TRIDENTATA WHOLE - 12 [hp_C]/mL LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER - 12 [hp_C]/mL LAWSONIA INERMIS FLOWERING TOP - 12 [hp_C]/mL LONICERA CAPRIFOLIUM FLOWER - 12 [hp_C]/mL MALVA NEGLECTA WHOLE - 12 [hp_C]/mL MATRICARIA CHAMOMILLA FLOWERING TOP - 12 [hp_C]/mL PASSIFLORA INCARNATA FLOWERING TOP - 4 [hp_X]/mL PENSTEMON DAVIDSONII WHOLE - 12 [hp_C]/mL PETUNIA AXILLARIS WHOLE - 12 [hp_C]/mL PLANTAGO MAJOR - 4 [hp_X]/mL PRUNELLA VULGARIS FLOWER - 12 [hp_C]/mL RANUNCULUS BULBOSUS WHOLE - 12 [hp_C]/mL ROSA CALIFORNICA WHOLE - 12 [hp_C]/mL SALIX ALBA FLOWERING TOP - 12 [hp_C]/mL SALVIA OFFICINALIS FLOWERING TOP - 12 [hp_C]/mL SEPIA OFFICINALIS JUICE - 30 [hp_C]/mL SILICON DIOXIDE - 12 [hp_C]/mL STRYCHNOS NUX-VOMICA SEED - 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: | 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: | 0818960011987 |
| UPC stands for Universal Product Code. | |
| NUI: | N0000185375 N0000185371 N0000175629 N0000184306 M0000728 M0006342 M0016962 M0022575 N0000185001 M0516536 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | KK0Z92II8M 5811MI029U OZ0E5Y15PZ S7V92P67HO 45E08M336T D9PC510CQV 831MXG026J 00UK7646FG 01800C6E6B 7JX5YDQ0D6 Load more... 21AF0IHY5U CVM893280N BKJ0J3D1BP PH797NEU5T XMQ0V9812O 3BA2N709NG VSW71SS07I B755J144H1 19AH1RAF4M UF2093XE64 5N1WD9784U S0QQA41760 3VNC7T6Z02 CLF5YFS11O 8K9DCX606Z B7U2BWH3OT W2469WNO6U AT1FD041EF AEQ8NXJ0MB H14X4P9EKJ XBP5X7E70R 48JCS720FN QDL83WN8C2 ETJ7Z6XBU4 269XH13919 |
| 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 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: | Allergens [CS] Dietary Proteins [CS] Plant Proteins [CS] Vegetable Proteins [CS] Seed Storage 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] Increased IgG Production [PE] Non-Standardized Food Allergenic Extract [EPC] Non-Standardized Plant Allergenic Extract [EPC] Plant Proteins [CS] Seed Storage 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 |
|---|---|---|---|---|
| 63479-0625-1 | 30 mL in 1 BOTTLE, GLASS (63479-0625-1) | 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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