| Drug NDC: | 63479-0610 |
| 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: | F10 Wrmlv |
| Also known as the trade name. It is the name of the product chosen by the labeler. | |
| Proprietary Name Base: | F10 |
| The base of the Brand/Proprietary name excluding its suffix. | |
| Proprietary Name Suffix: | WRMLV |
| 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, Aloe Vera, Aurum Metallicum, Azurite, Basil, Calendula Officinalis, Carica Papaya, Cayenne, Daffodil, Dicentra Formosa, Diplacus Aurantiacus, Hibiscus Chinensis, Horse Chestnut, Hylotelephium Telephium, Lavandula Stoechas, Lilium Tigrinum, Malva Neglecta, Melilotus Alba, Nelumbo Nucifera, Phosphorus, Prunella Vulgaris, Rosa Luciae, Rosemary, Scutellaria Lateriflora, Sepia, Silicea, Thuja Occidentalis, Toxicodendron Diversilobum, Viola Odorata, Yellow Jasmine |
| 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: | ABELMOSCHUS MOSCHATUS FLOWER - 12 [hp_C]/mL AESCULUS HIPPOCASTANUM FLOWER - 12 [hp_C]/mL AGRIMONIA EUPATORIA FLOWER - 12 [hp_C]/mL ALOE VERA FLOWER - 12 [hp_C]/mL AZURITE - 12 [hp_C]/mL CALENDULA OFFICINALIS FLOWERING TOP - 12 [hp_C]/mL CAPSICUM - 12 [hp_C]/mL CARICA PAPAYA WHOLE - 12 [hp_C]/mL DICENTRA FORMOSA WHOLE - 12 [hp_C]/mL DIPLACUS AURANTIACUS WHOLE - 12 [hp_C]/mL Load more... GELSEMIUM SEMPERVIRENS ROOT - 12 [hp_C]/mL GOLD - 12 [hp_C]/mL HYLOTELEPHIUM TELEPHIUM WHOLE - 12 [hp_C]/mL LAVANDULA STOECHAS FLOWERING TOP - 12 [hp_C]/mL LILIUM LANCIFOLIUM WHOLE FLOWERING - 12 [hp_C]/mL MALVA NEGLECTA WHOLE - 12 [hp_C]/mL MELILOTUS ALBUS TOP - 12 [hp_C]/mL NARCISSUS PSEUDONARCISSUS FLOWER - 12 [hp_C]/mL NELUMBO NUCIFERA FLOWER - 12 [hp_C]/mL OCIMUM BASILICUM FLOWERING TOP - 12 [hp_C]/mL PHOSPHORUS - 12 [hp_C]/mL PRUNELLA VULGARIS FLOWER - 12 [hp_C]/mL ROSA LUCIAE FLOWERING TOP - 12 [hp_C]/mL ROSMARINUS OFFICINALIS FLOWER - 12 [hp_C]/mL SCUTELLARIA LATERIFLORA TOP - 12 [hp_C]/mL SEPIA OFFICINALIS JUICE - 12 [hp_C]/mL SILICON DIOXIDE - 12 [hp_C]/mL THUJA OCCIDENTALIS LEAFY TWIG - 12 [hp_C]/mL TOXICODENDRON DIVERSILOBUM WHOLE - 12 [hp_C]/mL VIOLA ODORATA FLOWER - 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: | 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. | |
| UPC: | 0818960011840 |
| UPC stands for Universal Product Code. | |
| NUI: | N0000185375 N0000185371 N0000175629 N0000184306 M0000728 M0006342 M0016962 M0022575 N0000185508 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | 599O6K8K81 KK0Z92II8M 5811MI029U 575DY8C1ER 9AD6E582QL 18E7415PXQ 00UK7646FG S0U63B0Q51 6OFG7K362R TO6G4140YA Load more... 639KR60Q1Q 79Y1949PYO PH797NEU5T 70759G2U6A X67Z2963PI S0QQA41760 123T84GFBH L879RBF1WN 61W322NLDV 7SAB275FP2 27YLU75U4W AT1FD041EF 0PMA62ZZ6X NR1A27F29O C6CNB75R61 QDL83WN8C2 ETJ7Z6XBU4 1NT28V9397 9211E5735B 438W01FC7A |
| 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] 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: | Allergens [CS] Dietary Proteins [CS] Plant Proteins [CS] Vegetable 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] Standardized Chemical Allergen [EPC] 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 |
|---|---|---|---|---|
| 63479-0610-1 | 30 mL in 1 BOTTLE, GLASS (63479-0610-1) | 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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