| Drug NDC: | 63776-320 |
| 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: | Male Plus |
| 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: | Bos Taurus Adrenal Gland, Sus Scrofa Adrenal Gland, Aldosterone, Androsterone, Adenosine Cyclic 3,5-phosphate, Cholesterol, Prasterone, Somatropin, Bos Taurus Hypothalamus, Sus Scrofa Hypothalamus, Melatonin, Bos Taurus Pancreas, Sus Scrofa Pancreas, Bos Taurus Pineal Gland, Sus Scrofa Pineal Gland, Bos Taurus Pituitary Gland, Sus Scrofa Pituitary Gland, Bos Taurus Prostate Gland, Sus Scrofa Prostate, Bos Taurus Testicle, Sus Scrofa Testicle, Testosterone, Sus Scrofa Thalamus |
| Also known as the generic name, this is usually the active ingredient(s) of the product. | |
| Labeler Name: | Viatrexx Bio Incorporated |
| Name of Company corresponding to the labeler code segment of the ProductNDC. | |
| Dosage Form: | Spray |
| 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: | ADENOSINE CYCLIC PHOSPHATE - 200 [kp_C]/mL ALDOSTERONE - 200 [kp_C]/mL ANDROSTERONE - 200 [kp_C]/mL BOS TAURUS ADRENAL GLAND - 200 [kp_C]/mL BOS TAURUS HYPOTHALAMUS - 200 [kp_C]/mL BOS TAURUS PANCREAS - 200 [kp_C]/mL BOS TAURUS PINEAL GLAND - 200 [kp_C]/mL BOS TAURUS PITUITARY GLAND - 200 [kp_C]/mL BOS TAURUS PROSTATE GLAND - 200 [kp_C]/mL BOS TAURUS TESTICLE - 200 [kp_C]/mL Load more... BOS TAURUS THYMUS - 200 [kp_C]/mL CHOLESTEROL - 200 [kp_C]/mL MELATONIN - 200 [kp_C]/mL PRASTERONE - 200 [kp_C]/mL SOMATROPIN - 200 [kp_C]/mL SUS SCROFA ADRENAL GLAND - 200 [kp_C]/mL SUS SCROFA HYPOTHALAMUS - 200 [kp_C]/mL SUS SCROFA PANCREAS - 200 [kp_C]/mL SUS SCROFA PINEAL GLAND - 200 [kp_C]/mL SUS SCROFA PITUITARY GLAND - 200 [kp_C]/mL SUS SCROFA PROSTATE - 200 [kp_C]/mL SUS SCROFA TESTICLE - 200 [kp_C]/mL SUS SCROFA THALAMUS - 200 [kp_C]/mL SUS SCROFA THYMUS - 200 [kp_C]/mL TESTOSTERONE - 200 [kp_C]/mL THYROID, BOVINE - 200 [kp_C]/mL THYROID, PORCINE - 200 [kp_C]/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: | 24 Jul, 2012 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 22 Jun, 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: | VIATREXX BIO INCORPORATED |
| 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: | 0063776320154 |
| UPC stands for Universal Product Code. | |
| NUI: | N0000175606 M0028842 N0000175824 N0000000146 M0001109 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | E0399OZS9N 4964P6T9RB C24W7J5D5R M2776SWB29 S6G2NLH4Y7 1M529TNT1D Z7RM5NBH36 7JM57I419K 1P66FXU2MW PR4RXL6G2H Load more... 8XEJ88V2T8 97C5T2UQ7J JL5DK93RCL 459AG36T1B NQX9KB6PCL 398IYQ16YV N6R0856Z79 9Y3J3362RY 050QZ2EDK7 L0PFEMQ1DT O6UD3347K2 KM02613O28 3D6Q7UV74J 7B69B0BD62 3XMK78S47O MN18OTN73W 6RV024OAUQ |
| 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: | 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: | Recombinant Human Growth Hormone [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: | Human Growth Hormone [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: | Androgen Receptor Agonists [MoA] Androgen [EPC] Androstanes [CS] Human Growth Hormone [CS] Recombinant Human Growth Hormone [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 |
|---|---|---|---|---|
| 63776-320-15 | 1 BOTTLE, SPRAY in 1 BOX (63776-320-15) / 50 mL in 1 BOTTLE, SPRAY | 24 Jul, 2012 | 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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