| Drug NDC: | 63083-9202 |
| 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: | Aesculus Combination 9202 |
| Also known as the trade name. It is the name of the product chosen by the labeler. | |
| Proprietary Name Base: | Aesculus Combination |
| The base of the Brand/Proprietary name excluding its suffix. | |
| Proprietary Name Suffix: | 9202 |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. | |
| 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: | Aesculus Combination |
| Also known as the generic name, this is usually the active ingredient(s) of the product. | |
| Labeler Name: | Professional Complementary Health Formulas |
| Name of Company corresponding to the labeler code segment of the ProductNDC. | |
| Dosage Form: | Liquid |
| 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: | APIS MELLIFERA - 4 [hp_X]/29.5mL ARNICA MONTANA WHOLE - 3 [hp_X]/29.5mL AVISCUMINE - 3 [hp_X]/29.5mL BAPTISIA TINCTORIA WHOLE - 4 [hp_X]/29.5mL BARIUM IODIDE - 6 [hp_X]/29.5mL BEEF HEART - 10 [hp_X]/29.5mL BENZOIC ACID - 4 [hp_X]/29.5mL CLAVICEPS PURPUREA SCLEROTIUM - 3 [hp_X]/29.5mL COLCHICUM AUTUMNALE BULB - 4 [hp_X]/29.5mL COPPER - 13 [hp_X]/29.5mL Load more... ECHINACEA ANGUSTIFOLIA WHOLE - 2 [hp_X]/29.5mL EUPATORIUM PERFOLIATUM FLOWERING TOP - 6 [hp_X]/29.5mL HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - 4 [hp_X]/29.5mL HORSE CHESTNUT - 1 [hp_X]/29.5mL RUTA GRAVEOLENS FLOWERING TOP - 4 [hp_X]/29.5mL SODIUM PYRUVATE - 8 [hp_X]/29.5mL SOLANUM NIGRUM TOP - 6 [hp_X]/29.5mL SULFUR - 30 [hp_X]/29.5mL TOBACCO LEAF - 10 [hp_X]/29.5mL TOXICODENDRON PUBESCENS LEAF - 6 [hp_X]/29.5mL |
| 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: | 15 Aug, 1984 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 24 Dec, 2025 |
| 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: | Professional Complementary Health Formulas |
| 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: | N0000185021 N0000175629 N0000184306 N0000185001 M0000728 M0002274 N0000175806 N0000175807 M0005152 N0000175831 N0000008595 N0000008924 N0000175830 N0000185375 M0016962 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | 7S82P3R43Z O80TY208ZW 4B18YVW82N 5K1UO2888Y WKC4T7680A P47W069U38 8SKN0B0MIM 01G9XEA93N 993QHL78E6 789U1901C5 Load more... VB06AV5US8 1W0775VX6E T7S323PKJS 3C18L6RJAZ N94C2U587S POD38AIF08 O4G5C1G3W5 70FD1KFU70 6YR2608RSU 6IO182RP7A |
| 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: | Ammonium Ion Binding Activity [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: | Standardized Insect Venom Allergenic Extract [EPC] Nitrogen Binding Agent [EPC] Copper-containing Intrauterine Device [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] Decreased Embryonic Implantation [PE] Decreased Sperm Motility [PE] Inhibit Ovum Fertilization [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: | Allergens [CS] Bee Venoms [CS] Copper [CS] Plant 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] Ammonium Ion Binding Activity [MoA] Bee Venoms [CS] Cell-mediated Immunity [PE] Copper [CS] Copper-containing Intrauterine Device [EPC] Decreased Embryonic Implantation [PE] Decreased Sperm Motility [PE] Increased Histamine Release [PE] Increased IgG Production [PE] Inhibit Ovum Fertilization [PE] Nitrogen Binding Agent [EPC] Non-Standardized Plant Allergenic Extract [EPC] Plant Proteins [CS] Standardized Insect Venom Allergenic Extract [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 |
|---|---|---|---|---|
| 63083-9202-1 | 29.5 mL in 1 BOTTLE, DROPPER (63083-9202-1) | 15 Aug, 1985 | 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.