| Drug NDC: | 17089-346 |
| 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: | Guna-prostate |
| 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: | Aldesleukin - Barium Carbonate - Chaste Tree - Chimaphila Umbellata - Clematis Vitalba - Conium Maculatum Flowering Top - Delphinium Staphisagria Seed - Digitalis - Ferric Picrate - Human Interleukin-10 (nonglycosylated) - Interferon Gamma-1b - Melatonin - Saw Palmetto - Selenium - Sus Scrofa Prostate - Thuja Occidentalis Twig - Transforming Growth Factor Beta-1 - Zinc - |
| Also known as the generic name, this is usually the active ingredient(s) of the product. | |
| Labeler Name: | Guna Spa |
| 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: | ALDESLEUKIN - 4 [hp_C]/30mL BARIUM CARBONATE - 30 [hp_X]/30mL CHASTE TREE - 6 [hp_X]/30mL CHIMAPHILA UMBELLATA - 6 [hp_X]/30mL CLEMATIS RECTA FLOWERING TOP - 3 [hp_X]/30mL CONIUM MACULATUM FLOWERING TOP - 30 [hp_X]/30mL DELPHINIUM STAPHISAGRIA SEED - 30 [hp_X]/30mL DIGITALIS - 30 [hp_X]/30mL FERRIC PICRATE - 30 [hp_X]/30mL INTERFERON GAMMA-1B - 4 [hp_C]/30mL Load more... INTERLEUKIN-10 - 4 [hp_C]/30mL MELATONIN - 4 [hp_C]/30mL SAW PALMETTO - 3 [hp_X]/30mL SELENIUM - 30 [hp_X]/30mL SUS SCROFA PROSTATE - 200 [hp_X]/30mL THUJA OCCIDENTALIS LEAFY TWIG - 30 [hp_X]/30mL TRANSFORMING GROWTH FACTOR BETA-1 - 4 [hp_C]/30mL ZINC - 3 [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: | 01 Jan, 2017 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 12 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: | Guna spa |
| 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: | N0000178328 N0000009391 M0011506 N0000175667 N0000175541 M0011490 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | M89N0Q7EQR 6P669D8HQ8 433OSF3U8A WCK21A9W9J 396421SP9F Q28R5GF371 00543AP1JV F1T8QT9U8B KZM8ZRY36A 21K6M2I7AG Load more... 9SC4O216V9 JL5DK93RCL J7WWH9M8QS H6241UJ22B O6UD3347K2 1NT28V9397 T7D25J14LT J41CSQ7QDS |
| 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: | Lymphocyte Growth Factor [EPC] Interferon gamma [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 Lymphocyte Activation [PE] Increased Lymphocyte Cell Production [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: | Interleukin-2 [CS] Interferon-gamma [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: | Increased Lymphocyte Activation [PE] Increased Lymphocyte Cell Production [PE] Interferon gamma [EPC] Interferon-gamma [CS] Interleukin-2 [CS] Iron [CS] Lymphocyte Growth Factor [EPC] Parenteral Iron Replacement [EPC] Phosphate Binder [EPC] Phosphate Chelating Activity [MoA] |
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. | |
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|---|---|---|---|
| 17089-346-18 | 1 BOTTLE, DROPPER in 1 BOX (17089-346-18) / 30 mL in 1 BOTTLE, DROPPER | 21 Dec, 2018 | 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. | ||||
* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.