| Drug NDC: | 17089-450 |
| 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-cell |
| 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: | Acetylcarnitine, L-ampc-alpha-lipoic Ac-a-tocopherol-ascorbic Acid-calc Carb-citric Ac-cobalamin-colchicum-conium-cupric Sulf-herring Sperm Dna-ferrous Fumarate-folic Acid-fumaric Acid-kali Aspartate-mang Phos-mang Gluconate-mang Phos Ii-pyruvaldehyde-nat Oxalaceticum-sodium Pyruvate-niacin-pantothenic Acid-ph-podophyllum Peltatum-pyridoxine Hydrochloride-riboflavin-saccharomyces Cerevisiae Rna-selenomethionine-succinic Acid-sulfur-thiamine Hydrochloride-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: | .ALPHA.-LIPOIC ACID - 3 [hp_X]/30mL .ALPHA.-TOCOPHEROL ACETATE, DL- - 3 [hp_X]/30mL ACETYLCARNITINE - 3 [hp_X]/30mL ADENOSINE CYCLIC PHOSPHATE - 6 [hp_X]/30mL ASCORBIC ACID - 3 [hp_X]/30mL CALCIUM CARBONATE - 3 [hp_X]/30mL CITRIC ACID MONOHYDRATE - 3 [hp_X]/30mL COBALAMIN - 3 [hp_X]/30mL COLCHICUM AUTUMNALE BULB - 6 [hp_X]/30mL CONIUM MACULATUM FLOWERING TOP - 6 [hp_X]/30mL Load more... CUPRIC SULFATE - 3 [hp_X]/30mL FERROUS FUMARATE - 3 [hp_X]/30mL FOLIC ACID - 3 [hp_X]/30mL FUMARIC ACID - 3 [hp_X]/30mL HERRING SPERM DNA - 6 [hp_X]/30mL MAGNESIUM PHOSPHATE, TRIBASIC, PENTAHYDRATE - 3 [hp_X]/30mL MANGANESE GLUCONATE - 3 [hp_X]/30mL MANGANESE PHOSPHATE, DIBASIC - 6 [hp_X]/30mL NIACIN - 3 [hp_X]/30mL PANTOTHENIC ACID - 3 [hp_X]/30mL PHOSPHORUS - 4 [hp_X]/30mL PODOPHYLLUM PELTATUM ROOT - 6 [hp_X]/30mL POTASSIUM ASPARTATE - 3 [hp_X]/30mL PYRIDOXINE HYDROCHLORIDE - 6 [hp_X]/30mL PYRUVALDEHYDE - 10 [hp_X]/30mL RIBOFLAVIN - 6 [hp_X]/30mL SACCHAROMYCES CEREVISIAE RNA - 6 [hp_X]/30mL SELENOMETHIONINE - 3 [hp_X]/30mL SODIUM DIETHYL OXALACETATE - 3 [hp_X]/30mL SODIUM PYRUVATE - 3 [hp_X]/30mL SUCCINIC ACID - 3 [hp_X]/30mL SULFUR - 3 [hp_X]/30mL THIAMINE HYDROCHLORIDE - 4 [hp_X]/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: | 27 May, 2010 |
| 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: | 0317089450184 |
| UPC stands for Universal Product Code. | |
| NUI: | N0000193618 M0001797 N0000175594 M0014839 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | 73Y7P0K73Y WR1WPI7EW8 6DH1W9VH8Q E0399OZS9N PQ6CK8PD0R H0G9379FGK 2968PHW8QP 8406EY2OQA 993QHL78E6 Q28R5GF371 Load more... LRX7AJ16DT R5L488RY0Q 935E97BOY8 88XHZ13131 51FI676N6F 453COF7817 9YY2F980SV VZ3U1H7Q5B 2679MF687A 19F5HK2737 27YLU75U4W 2S713A4VP3 OC4598NZEQ 68Y4CF58BV 722KLD7415 TLM2976OFR J17GBZ5VGX 964MRK2PEL 6CA025Y4FG POD38AIF08 AB6MNQ6J6L 70FD1KFU70 M572600E5P 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: | Vitamin C [EPC] Nicotinic Acid [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] Nicotinic Acids [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: | Acidifying Activity [MoA] Analogs/Derivatives [Chemical/Ingredient] Anti-coagulant [EPC] Ascorbic Acid [CS] Blood Coagulation Factor [EPC] Calcium Chelating Activity [MoA] Calcium [CS] Calculi Dissolution Agent [EPC] Carnitine Analog [EPC] Carnitine [CS] Cations Divalent [CS] Decreased Coagulation Factor Activity [PE] Increased Coagulation Factor Activity [PE] Increased Large Intestinal Motility [PE] Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] Inhibition Small Intestine Fluid/Electrolyte Absorption [PE] Magnesium Ion Exchange Activity [MoA] Magnetic Resonance Contrast Activity [MoA] Nicotinic Acid [EPC] Nicotinic Acids [CS] Osmotic Activity [MoA] Osmotic Laxative [EPC] Paramagnetic Contrast Agent [EPC] Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] Vitamin B 6 [Chemical/Ingredient] Vitamin B6 Analog [EPC] 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 |
|---|---|---|---|---|
| 17089-450-18 | 1 BOTTLE, DROPPER in 1 BOX (17089-450-18) / 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.