| Drug NDC: | 43742-2051 |
| 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: | High Vitality |
| 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: | Agnus Castus, Ambra Grisea, Petroselinum Sativum, Estradiol, L-dopa, Melatonin, Testosterone, Adenosinum Triphosphoricum Dinatrum, Alpha-lipoicum Acidum, Nadidum, Pantothenic Acid, Sarcolacticum Acidum, Ubidecarenonum, Baryta Carbonica, Conium Maculatum, Selenium Metallicum, Folliculinum, Funiculus Umbilicalis Suis, Gaba, Glandula Suprarenalis Suis, Hepar Suis, Hypothalamus Suis, Lymph Node (suis), Medulla Ossis Suis, Oophorinum (suis), Orchitinum (suis), Pancreas Suis, Spleen (suis), Apiolum, |
| Also known as the generic name, this is usually the active ingredient(s) of the product. | |
| Labeler Name: | Deseret Biologicals, 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: | .GAMMA.-AMINOBUTYRIC ACID - 30 [hp_X]/mL ADENOSINE TRIPHOSPHATE DISODIUM - 8 [hp_X]/mL ALPHA LIPOIC ACID - 8 [hp_X]/mL AMBERGRIS - 6 [hp_X]/mL APIOLE (PARSLEY) - 14 [hp_C]/mL BARIUM CARBONATE - 8 [hp_X]/mL CHASTE TREE FRUIT - 6 [hp_X]/mL CONIUM MACULATUM FLOWERING TOP - 8 [hp_X]/mL ESTRADIOL - 6 [hp_X]/mL ESTRONE - 8 [hp_X]/mL Load more... LACTIC ACID, L- - 8 [hp_X]/mL LEVODOPA - 6 [hp_X]/mL MELATONIN - 6 [hp_X]/mL NADIDE - 8 [hp_X]/mL PANTOTHENIC ACID - 8 [hp_X]/mL PETROSELINUM CRISPUM WHOLE - 6 [hp_X]/mL PORK LIVER - 30 [hp_X]/mL PROTEUS MORGANII - 30 [hp_C]/mL SELENIUM - 8 [hp_X]/mL SUS SCROFA ADRENAL GLAND - 30 [hp_X]/mL SUS SCROFA BONE MARROW - 30 [hp_X]/mL SUS SCROFA HYPOTHALAMUS - 30 [hp_X]/mL SUS SCROFA LYMPH - 30 [hp_X]/mL SUS SCROFA OVARY - 30 [hp_X]/mL SUS SCROFA PANCREAS - 30 [hp_X]/mL SUS SCROFA PITUITARY GLAND - 30 [hp_X]/mL SUS SCROFA SPLEEN - 30 [hp_X]/mL SUS SCROFA TESTICLE - 30 [hp_X]/mL SUS SCROFA UMBILICAL CORD - 30 [hp_X]/mL TESTOSTERONE - 6 [hp_X]/mL UBIDECARENONE - 8 [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: | 03 May, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 03 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: | Deseret Biologicals, 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: | M0447348 N0000175825 N0000000100 N0000193220 M0370111 N0000175824 N0000000146 M0001109 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | 2ACZ6IPC6I 5L51B4DR1G 73Y7P0K73Y XTC0D02P6C QQ67504PXO 6P669D8HQ8 433OSF3U8A Q28R5GF371 4TI98Z838E 2DI9HA706A Load more... F9S9FFU82N 46627O600J JL5DK93RCL 0U46U6E8UK 19F5HK2737 1WZA4Y92EX 6EC706HI7F 56X6LID5ZY H6241UJ22B 398IYQ16YV VP2CN2G7Y8 N6R0856Z79 33A7VYU29L S7YTV04R8O 9Y3J3362RY L0PFEMQ1DT 92AMN5J79Y KM02613O28 118OYG6W3H 3XMK78S47O EJ27X76M46 |
| 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: | Estrogen Receptor Agonists [MoA] Androgen Receptor 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: | Estrogen [EPC] Aromatic Amino Acid [EPC] Androgen [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 CS: | Estradiol Congeners [CS] Amino Acids, Aromatic [CS] Androstanes [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: | Amino Acids Aromatic [CS] Androgen Receptor Agonists [MoA] Androgen [EPC] Androstanes [CS] Aromatic Amino Acid [EPC] Estradiol Congeners [CS] Estrogen Receptor Agonists [MoA] Estrogen [EPC] |
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. | |
| DEA Schedule: | CIII |
| This is the assigned DEA Schedule number as reported by the labeler. Values are CI, CII, CIII, CIV, and CV. | |
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|---|---|---|---|
| 43742-2051-1 | 30 mL in 1 BOTTLE, DROPPER (43742-2051-1) | 03 May, 2022 | 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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