| Drug NDC: | 63776-035 |
| 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: | Arthros |
| 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: | Anti-interleukin-1.alpha. Immunoglobulin G Rabbit, .alpha.-ketoglutaric Acid, .alpha.-lipoic Acid, Apomorphine, Bos Taurus Joint Capsule, Sus Scrofa Joint Capsule, Ascorbic Acid, Bos Taurus Adrenal Gland, Sus Scrofa Adrenal Gland, Brain-derived Neurotrophic Factor Human, Metenkefalin, Ersofermin, Bos Taurus Solar Plexus, Sus Scrofa Solar Plexus, Calcitonin, Bos Taurus Cartilage, Sus Scrofa Cartilage, Colchicum Autumnale Bulb, Pork Collagen, Bos Taurus Red Blood Cell, Sus Scrofa Red Blood Cell |
| Also known as the generic name, this is usually the active ingredient(s) of the product. | |
| Labeler Name: | Viatrexx Bio Incorporated |
| Name of Company corresponding to the labeler code segment of the ProductNDC. | |
| Dosage Form: | Spray |
| 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 - 30 [kp_C]/mL .ALPHA.-LIPOIC ACID - 30 [kp_C]/mL ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT - 200 [kp_C]/mL APOMORPHINE - 30 [kp_C]/mL ASCORBIC ACID - 30 [kp_C]/mL BEEF LIVER - 200 [kp_C]/mL BOS TAURUS ADRENAL GLAND - 200 [kp_C]/mL BOS TAURUS CARTILAGE - 200 [kp_C]/mL BOS TAURUS JOINT CAPSULE - 200 [kp_C]/mL BOS TAURUS LYMPH - 200 [kp_C]/mL Load more... BOS TAURUS MESENCHYME - 200 [hp_Q]/mL BOS TAURUS PARATHYROID GLAND - 200 [kp_C]/mL BOS TAURUS PLACENTA - 30 [kp_C]/mL BOS TAURUS RED BLOOD CELL - 200 [kp_C]/mL BOS TAURUS SOLAR PLEXUS - 200 [kp_C]/mL BOS TAURUS VEIN - 30 [kp_C]/mL BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN - 200 [kp_C]/mL CALCITONIN - 200 [kp_C]/mL COLCHICUM AUTUMNALE BULB - 200 [kp_C]/mL EDODEKIN ALFA - 200 [kp_C]/mL ERSOFERMIN - 200 [kp_C]/mL INTERFERON GAMMA-1A - 200 [kp_C]/mL METENKEFALIN - 200 [kp_C]/mL NADIDE - 30 [kp_C]/mL PORK COLLAGEN - 200 [kp_C]/mL PORK LIVER - 200 [kp_C]/mL QUINHYDRONE - 30 [kp_C]/mL SULFUR - 30 [kp_C]/mL SUS SCROFA ADRENAL GLAND - 200 [kp_C]/mL SUS SCROFA CARTILAGE - 200 [kp_C]/mL SUS SCROFA JOINT CAPSULE - 200 [kp_C]/mL SUS SCROFA LYMPH - 200 [kp_C]/mL SUS SCROFA MESENCHYME - 200 [hp_Q]/mL SUS SCROFA PARATHYROID GLAND - 200 [kp_C]/mL SUS SCROFA RED BLOOD CELL - 200 [kp_C]/mL SUS SCROFA SOLAR PLEXUS - 200 [kp_C]/mL SUS SCROFA VEIN - 30 [kp_C]/mL |
| 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: | 24 Jul, 2012 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 13 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, 2024 |
| This is the date when the listing record will expire if not updated or certified by the firm. | |
| Manufacturer Name: | VIATREXX BIO INCORPORATED |
| 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. | |
| NUI: | N0000000117 N0000175580 N0000193618 M0001797 N0000185371 N0000175629 N0000184306 M0000728 M0006342 N0000185017 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | 8ID597Z82X 73Y7P0K73Y ML4QRZ1HCL N21FAR7B4S PQ6CK8PD0R W8N8R55022 M2776SWB29 UE77B10IIY 782I3O9VSM UGE0WQC19W Load more... 3802H34QRI SMV71DDI4T 83AL37E3A7 5W4FLB0U2C Y8H8S1X8IB 3H31IR83LT A1ED6W905I DF35I47HCM 993QHL78E6 31Z82G8ME1 1NWT5SW3NW VC9M78242P 9JEZ9OD3AS 0U46U6E8UK I8442U2G7J 6EC706HI7F P4A66LQ3QJ 70FD1KFU70 398IYQ16YV 73ECW5WG2F LX0XHE5NLN 33A7VYU29L UH52A16DZB 2KBE35NE8S 5X23IGF970 WN6M3MGG1X 2510RH3I89 |
| 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 MOA: | Dopamine Agonists [MoA] |
| Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`. | |
| Pharmacologic Class EPC: | Dopaminergic Agonist [EPC] Vitamin C [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: | Ascorbic Acid [CS] Allergens [CS] Dietary 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] Depigmenting Activity [PE] Dietary Proteins [CS] Dopamine Agonists [MoA] Dopaminergic Agonist [EPC] Increased Histamine Release [PE] Meat Proteins [EXT] Melanin Synthesis Inhibitor [EPC] Melanin Synthesis Inhibitors [MoA] Non-Standardized Food Allergenic Extract [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 |
|---|---|---|---|---|
| 63776-035-14 | 1 BOTTLE, SPRAY in 1 BOX (63776-035-14) / 30 mL in 1 BOTTLE, SPRAY | 24 Jul, 2012 | 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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