| Drug NDC: | 17089-349 |
| 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-geriatrics |
| 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: | 1,4-benzoquinone - Arnica Montana - Oxytocin - Barium Carbonate - Barium Oxalosuccinate - Corticotropin - Lead - Levothyroxine - Lutrelin - Malic Acid - Melatonin - Neurotrophin-3 - Neurotrophin-4 - Phenylalanine - Pork Liver - Pyruvic Acid - Rinfabate - Sus Scrofa Adrenal Gland - Sus Scrofa Frontal Lobe - Sus Scrofa Hypothalamus - Thyrotropin Alfa - Brain-derived Neurotrophic Factor Human - |
| 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: | ARNICA MONTANA - 6 [hp_X]/30mL BARIUM CARBONATE - 6 [hp_X]/30mL BARIUM OXALOSUCCINATE - 3 [hp_X]/30mL BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN - 4 [hp_C]/30mL CORTICOTROPIN - 6 [hp_X]/30mL LEAD - 6 [hp_X]/30mL LEVOTHYROXINE - 6 [hp_X]/30mL LUTRELIN - 6 [hp_X]/30mL MALIC ACID - 3 [hp_X]/30mL MELATONIN - 4 [hp_C]/30mL Load more... NEUROTROPHIN-3 - 4 [hp_C]/30mL NEUROTROPHIN-4 - 4 [hp_C]/30mL OXYTOCIN - 6 [hp_X]/30mL PHENYLALANINE - 3 [hp_X]/30mL PORK LIVER - 6 [hp_X]/30mL PYRUVIC ACID - 3 [hp_X]/30mL QUINONE - 3 [hp_X]/30mL RINFABATE - 4 [hp_C]/30mL SUS SCROFA ADRENAL GLAND - 6 [hp_X]/30mL SUS SCROFA FRONTAL LOBE - 6 [hp_X]/30mL SUS SCROFA HYPOTHALAMUS - 6 [hp_X]/30mL THYROTROPIN ALFA - 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: | 16 Apr, 2008 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 23 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: | 0317089349181 |
| UPC stands for Universal Product Code. | |
| NUI: | M0000499 N0000175941 N0000175945 M0021504 N0000009705 N0000175828 M0015703 N0000175949 M0021496 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | O80TY208ZW 6P669D8HQ8 L7A49804ZQ A1ED6W905I K0U68Q2TXA 2P299V784P Q51BO43MG4 QH51543Y7U 817L1N4CKP JL5DK93RCL Load more... 02R4V6T25Y P658DCA9XD 1JQS135EYN 47E5O17Y3R 6EC706HI7F 8558G7RUTR 3T006GV98U KU1MBT4JJB 398IYQ16YV GV54Q19G55 N6R0856Z79 AVX3D5A4LM |
| 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: | Adrenocorticotropic Hormone [EPC] l-Thyroxine [EPC] Oxytocic [EPC] Thyroid Stimulating Hormone [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 Uterine Smooth Muscle Contraction or Tone [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: | Adrenocorticotropic Hormone [CS] Thyroxine [CS] Oxytocin [CS] Thyrotropin [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: | Adrenocorticotropic Hormone [CS] Adrenocorticotropic Hormone [EPC] Increased Uterine Smooth Muscle Contraction or Tone [PE] Oxytocic [EPC] Oxytocin [CS] Thyroid Stimulating Hormone [EPC] Thyrotropin [CS] Thyroxine [CS] l-Thyroxine [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 |
|---|---|---|---|---|
| 17089-349-18 | 1 BOTTLE, DROPPER in 1 BOX (17089-349-18) / 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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