| Drug NDC: | 43853-0035 |
| 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: | Testopro |
| 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: | Avena Sativa, Damiana, Hamamelis Virginiana, Korean Ginseng, Populus Tremuloides, Baryta Carbonica, Hepar Suis, Nuphar Luteum, Orchitinum Suis, Phosphoricum Acidum, Sabal Serulata, Selenium Metallicum, Testosterone, Tribulus Terrestris, Horny Goat Weed, Tongkat Ali, Fenugreek |
| Also known as the generic name, this is usually the active ingredient(s) of the product. | |
| Labeler Name: | Problen |
| 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: | ASIAN GINSENG - 1 [hp_X]/30mL AVENA SATIVA FLOWERING TOP - 1 [hp_X]/30mL BARIUM CARBONATE - 8 [hp_X]/30mL EPIMEDIUM GRANDIFLORUM TOP - 6 [hp_X]/30mL EURYCOMA LONGIFOLIA WHOLE - 6 [hp_X]/30mL FENUGREEK SEED - 3 [hp_X]/30mL HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - 1 [hp_X]/30mL NUPHAR LUTEA ROOT - 3 [hp_X]/30mL PHOSPHORIC ACID - 12 [hp_X]/30mL POPULUS TREMULOIDES WHOLE - 1 [hp_X]/30mL Load more... PORK LIVER - 6 [hp_X]/30mL SAW PALMETTO - 6 [hp_X]/30mL SELENIUM - 12 [hp_X]/30mL SUS SCROFA TESTICLE - 6 [hp_X]/30mL TESTOSTERONE - 30 [hp_X]/30mL TRIBULUS TERRESTRIS WHOLE - 6 [hp_X]/30mL TURNERA DIFFUSA LEAFY TWIG - 1 [hp_X]/30mL |
| 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: | 28 Jun, 2017 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 15 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: | ProBlen |
| 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: | N0000175824 N0000000146 M0001109 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | CUQ3A77YXI MA9CQJ3F7F 6P669D8HQ8 137PC46F89 8GOM182CI3 654825W09Z T7S323PKJS 714LIU3V6D E4GA8884NN MUN0TBE4PE Load more... 6EC706HI7F J7WWH9M8QS H6241UJ22B KM02613O28 3XMK78S47O 4X4HLN92OT RQ2CFA7WWJ |
| 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: | 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: | 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] |
| 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 |
|---|---|---|---|---|
| 43853-0035-1 | 30 mL in 1 BOTTLE (43853-0035-1) | 28 Jun, 2017 | 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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