| Drug NDC: | 64616-086 |
| 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: | Category V |
| Also known as the trade name. It is the name of the product chosen by the labeler. | |
| 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: | Immune System Booster |
| Also known as the generic name, this is usually the active ingredient(s) of the product. | |
| Labeler Name: | Vitality Works, Inc, |
| Name of Company corresponding to the labeler code segment of the ProductNDC. | |
| Dosage Form: | Liquid |
| 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: | ANAGALLIS ARVENSIS - 3 [hp_X]/mL ANHYDROUS CITRIC ACID - 15 [hp_X]/mL AQUA REGIA - 15 [hp_X]/mL ARSENIC TRIIODIDE - 10 [hp_X]/mL CALCIUM LACTATE - 50 [hp_X]/mL CHAMAEMELUM NOBILE - 20 [hp_X]/mL COPPER - 25 [hp_X]/mL DELPHINIUM STAPHISAGRIA SEED - 5 [hp_X]/mL EPINEPHRINE - 15 [hp_X]/mL FRAXINUS AMERICANA BARK - 4 [hp_X]/mL Load more... HEXAPLEX TRUNCULUS HYPOBRANCHIAL GLAND JUICE - 14 [hp_X]/mL LACTIC ACID - 15 [hp_X]/mL PETROSELINUM CRISPUM - 20 [hp_X]/mL PICRIC ACID - 12 [hp_X]/mL POTASSIUM CARBONATE - 8 [hp_X]/mL SALICYLIC ACID - 12 [hp_X]/mL SALIX NIGRA BARK - 20 [hp_X]/mL STRYCHNOS IGNATII SEED - 4 [hp_X]/mL URANYL NITRATE HEXAHYDRATE - 17 [hp_X]/mL |
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. | |
| Route Details: | ORAL |
| 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: | 20 Mar, 2013 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 08 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: | Vitality Works, 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: | N0000175833 N0000175835 N0000175980 N0000008556 N0000175089 M0005152 N0000175831 N0000008595 N0000008924 N0000175830 N0000000209 N0000000245 N0000175552 N0000175555 N0000175570 M0003647 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | 46883LR90E XF417D3PSL X3TT5X989E 3029988O2T 2URQ2N32W3 7NF3GE7IWR 789U1901C5 00543AP1JV YKH834O4BH 0B24UR1O1S Load more... IQV54TN60Y 33X04XA5AT 1WZA4Y92EX A49OS0F91S BQN1B9B9HA O414PZ4LPZ QU52J3A5B3 1NM3M2487K 3V057702FY |
| 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: | Acidifying Activity [MoA] Calcium Chelating Activity [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: | Calculi Dissolution Agent [EPC] Anti-coagulant [EPC] Copper-containing Intrauterine Device [EPC] alpha-Adrenergic Agonist [EPC] beta-Adrenergic Agonist [EPC] Catecholamine [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: | Decreased Coagulation Factor Activity [PE] Decreased Embryonic Implantation [PE] Decreased Sperm Motility [PE] Inhibit Ovum Fertilization [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: | Copper [CS] Catecholamines [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: | Acidifying Activity [MoA] Adrenergic alpha-Agonists [MoA] Adrenergic beta-Agonists [MoA] Anti-coagulant [EPC] Blood Coagulation Factor [EPC] Calcium Chelating Activity [MoA] Calcium [CS] Calculi Dissolution Agent [EPC] Catecholamine [EPC] Catecholamines [CS] Cations Divalent [CS] Copper [CS] Copper-containing Intrauterine Device [EPC] Decreased Coagulation Factor Activity [PE] Decreased Embryonic Implantation [PE] Decreased Sperm Motility [PE] Increased Coagulation Factor Activity [PE] Inhibit Ovum Fertilization [PE] 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 |
|---|---|---|---|---|
| 64616-086-02 | 59 mL in 1 BOTTLE, DROPPER (64616-086-02) | 20 Mar, 2013 | 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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