| Drug NDC: | 17089-348 |
| 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-spasm |
| 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: | Atropine Sulfate - Berberis Vulgaris Root Bark - Chelidonium Majus - Cobalt - Cultivated Mushroom - Gelsemium Sempervirens Root - Interleukin-10 - Magnesium - Melatonin - Metenkefalin - Sus Scrofa Sympathetic Nerve - Sus Scrofa Vagus Nerve - Watermelon - Anti-interleukin-1.alpha. Immunoglobulin G Rabbit - |
| 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: | ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT - 4 [hp_C]/30mL ATROPINE SULFATE - 6 [hp_X]/30mL BERBERIS VULGARIS ROOT BARK - 3 [hp_X]/30mL CHELIDONIUM MAJUS - 4 [hp_X]/30mL COBALT - 4 [hp_X]/30mL CULTIVATED MUSHROOM - 4 [hp_X]/30mL GELSEMIUM SEMPERVIRENS ROOT - 6 [hp_X]/30mL INTERLEUKIN-10 - 4 [hp_C]/30mL MAGNESIUM - 4 [hp_X]/30mL MELATONIN - 4 [hp_C]/30mL Load more... METENKEFALIN - 4 [hp_C]/30mL SUS SCROFA SYMPATHETIC NERVE - 200 [hp_X]/30mL SUS SCROFA VAGUS NERVE - 6 [hp_X]/30mL WATERMELON - 4 [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: | 16 Apr, 2008 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 19 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. | |
| UPC: | 0317089348184 |
| UPC stands for Universal Product Code. | |
| NUI: | N0000185508 N0000175629 N0000184306 M0000728 N0000185371 M0006342 M0008890 N0000185015 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | ML4QRZ1HCL 03J5ZE7KA5 1TH8Q20J0U 7E889U5RNN 3G0H8C9362 54C8E6W6JY 639KR60Q1Q 9SC4O216V9 I38ZP9992A JL5DK93RCL Load more... 9JEZ9OD3AS H6L0IFR3FE 5AZZ2GHR69 231473QB6R |
| 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: | Standardized Chemical Allergen [EPC] Non-Standardized Food Allergenic Extract [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 Histamine Release [PE] Cell-mediated Immunity [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: | Allergens [CS] Dietary Proteins [CS] Fungal Proteins [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: | Allergens [CS] Anticholinergic [EPC] Cell-mediated Immunity [PE] Cholinergic Antagonists [MoA] Cholinergic Muscarinic Antagonist [EPC] Cholinergic Muscarinic Antagonists [MoA] Dietary Proteins [CS] Fruit Proteins [EXT] Fungal Proteins [CS] Increased Histamine Release [PE] Non-Standardized Food Allergenic Extract [EPC] Standardized Chemical Allergen [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 |
|---|---|---|---|---|
| 17089-348-18 | 1 BOTTLE, DROPPER in 1 BOX (17089-348-18) / 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. | ||||
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