| Drug NDC: | 17089-301 |
| 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-digest |
| 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: | Angelica Archangelica Root - Anisum - Artemisia Abrotanum Flowering Top - Ascorbic Acid - Citrullus Colocynthis Fruit Pulp - Gentiana Lutea Root - Melatonin - Niacin - Pancrelipase Amylase - Pancrelipase Lipase - Pork Liver - Serotonin - Strychnos Nux-vomica Seed - Sus Scrofa Diencephalon - Sus Scrofa Duodenum - Sus Scrofa Gall Bladder - Sus Scrofa Pancreas - Sus Scrofa Pylorus - Thiamine Hydrochloride - Trypsin - Tryptophan - |
| 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: | ANGELICA ARCHANGELICA ROOT - 1 [hp_X]/30mL ANISUM - 1 [hp_X]/30mL ARTEMISIA ABROTANUM FLOWERING TOP - 1 [hp_X]/30mL ASCORBIC ACID - 2 [hp_X]/30mL CITRULLUS COLOCYNTHIS FRUIT PULP - 3 [hp_X]/30mL GENTIANA LUTEA ROOT - 1 [hp_X]/30mL MELATONIN - 4 [hp_C]/30mL NIACIN - 2 [hp_X]/30mL PANCRELIPASE AMYLASE - 2 [hp_X]/30mL PANCRELIPASE LIPASE - 2 [hp_X]/30mL Load more... PORK LIVER - 8 [hp_X]/30mL SEROTONIN - 6 [hp_X]/30mL STRYCHNOS NUX-VOMICA SEED - 3 [hp_X]/30mL SUS SCROFA DIENCEPHALON - 6 [hp_X]/30mL SUS SCROFA DUODENUM - 8 [hp_X]/30mL SUS SCROFA GALLBLADDER - 8 [hp_X]/30mL SUS SCROFA PANCREAS - 8 [hp_X]/30mL SUS SCROFA PYLORUS - 8 [hp_X]/30mL THIAMINE HYDROCHLORIDE - 4 [hp_X]/30mL TRYPSIN - 2 [hp_X]/30mL TRYPTOPHAN - 6 [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: | 21 Dec, 2018 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 07 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: | 0317089301189 |
| UPC stands for Universal Product Code. | |
| NUI: | N0000193618 M0001797 N0000175594 M0014839 N0000185375 N0000175629 N0000184306 N0000185001 M0000728 M0016962 M0516536 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | DTN01M69SN 21C2F5E8RE QG07G580U0 PQ6CK8PD0R 23H32AOH17 S72O3284MS JL5DK93RCL 2679MF687A YOJ58O116E 8MYC33932O Load more... 6EC706HI7F 333DO1RDJY 269XH13919 23PJ4252VL P6J2SFT80O B6A98VOI9I 9Y3J3362RY JHM2AD7V9M M572600E5P GV54A213NN 8DUH1N11BX |
| 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] Nicotinic Acid [EPC] Non-Standardized Plant 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] Increased IgG 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: | Ascorbic Acid [CS] Nicotinic Acids [CS] Allergens [CS] Plant Proteins [CS] Seed Storage 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] Ascorbic Acid [CS] Cell-mediated Immunity [PE] Increased Histamine Release [PE] Increased IgG Production [PE] Nicotinic Acid [EPC] Nicotinic Acids [CS] Non-Standardized Plant Allergenic Extract [EPC] Plant Proteins [CS] Seed Storage Proteins [CS] 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 |
|---|---|---|---|---|
| 17089-301-18 | 1 BOTTLE, DROPPER in 1 BOX (17089-301-18) / 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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