| Drug NDC: | 17089-304 |
| 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-arthro |
| 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: | .alpha.-ketoglutaric Acid - Alpha Lipoic Acid - Ascorbic Acid - Barium Oxalosuccinate - Black Cohosh - Bryonia Alba Root - Calcitonin Human - Chlorine - Colchicum Autumnale Bulb - Nadide - |
| 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: | .ALPHA.-KETOGLUTARIC ACID - 3 [hp_X]/30mL .ALPHA.-LIPOIC ACID - 3 [hp_X]/30mL ASCORBIC ACID - 3 [hp_X]/30mL BARIUM OXALOSUCCINATE - 3 [hp_X]/30mL BLACK COHOSH - 6 [hp_X]/30mL BRYONIA ALBA ROOT - 6 [hp_X]/30mL CALCITONIN HUMAN - 6 [hp_X]/30mL CHLORINE - 6 [hp_X]/30mL COLCHICUM AUTUMNALE BULB - 6 [hp_X]/30mL NADIDE - 3 [hp_X]/30mL Load more... NERVE GROWTH FACTOR - 4 [hp_C]/30mL PRASTERONE - 6 [hp_X]/30mL QUINHYDRONE - 3 [hp_X]/30mL SODIUM DIETHYL OXALACETATE - 3 [hp_X]/30mL SOLANUM DULCAMARA FLOWER - 6 [hp_X]/30mL STRONTIUM CARBONATE - 6 [hp_X]/30mL SULFUR - 3 [hp_X]/30mL SUS SCROFA ADRENAL GLAND - 6 [hp_X]/30mL SUS SCROFA ARTERY - 6 [hp_X]/30mL SUS SCROFA CARTILAGE - 6 [hp_X]/30mL SUS SCROFA CONJUNCTIVA - 6 [hp_X]/30mL SUS SCROFA PARATHYROID GLAND - 6 [hp_X]/30mL SUS SCROFA PLACENTA - 6 [hp_X]/30mL SUS SCROFA UMBILICAL CORD - 6 [hp_X]/30mL SUS SCROFA VEIN - 6 [hp_X]/30mL TOXICODENDRON PUBESCENS LEAF - 6 [hp_X]/30mL VELAFERMIN - 4 [hp_C]/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: | 23 May, 2006 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 10 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: | 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: | 0317089304180 |
| UPC stands for Universal Product Code. | |
| NUI: | N0000193618 M0001797 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | 8ID597Z82X 73Y7P0K73Y PQ6CK8PD0R L7A49804ZQ K73E24S6X9 T7J046YI2B I0IO929019 4R7X1O2820 993QHL78E6 0U46U6E8UK Load more... V7FWP1D62O 459AG36T1B P4A66LQ3QJ 6CA025Y4FG W6J1279A6K 41YPU4MMCA 70FD1KFU70 398IYQ16YV 63O327782Q 73ECW5WG2F W61ME6Q717 2KBE35NE8S C8CV8867O8 118OYG6W3H 2510RH3I89 6IO182RP7A 6Z25C35927 |
| 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: | Vitamin C [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: | Ascorbic Acid [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: | Ascorbic Acid [CS] Depigmenting Activity [PE] Melanin Synthesis Inhibitor [EPC] Melanin Synthesis Inhibitors [MoA] Vitamin C [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 |
|---|---|---|---|---|
| 17089-304-18 | 1 BOTTLE, DROPPER in 1 BOX (17089-304-18) / 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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