| Drug NDC: | 63083-2128 |
| 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: | Lyme Nosode Drops 2128 |
| Also known as the trade name. It is the name of the product chosen by the labeler. | |
| Proprietary Name Base: | Lyme Nosode Drops |
| The base of the Brand/Proprietary name excluding its suffix. | |
| Proprietary Name Suffix: | 2128 |
| 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: | Lyme Nosode Drops |
| 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: | ANGELICA ARCHANGELICA ROOT - 2 [hp_X]/59mL ANGELICA PUBESCENS ROOT - 2 [hp_X]/59mL ARNICA MONTANA WHOLE - 8 [hp_X]/59mL BABESIA MICROTI - 12 [hp_X]/59mL BORRELIA BURGDORFERI - 12 [hp_X]/59mL BOVINE TYPE II COLLAGEN (TRACHEAL CARTILAGE) - 3 [hp_X]/59mL CAUSTICUM - 6 [hp_X]/59mL EHRLICHIA CHAFFEENSIS - 12 [hp_X]/59mL GAMBIR - 2 [hp_X]/59mL GOLDENSEAL - 5 [hp_X]/59mL Load more... LATIGLUTENASE - 8 [hp_X]/59mL LATRODECTUS MACTANS - 10 [hp_X]/59mL MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE - 2 [hp_X]/59mL MANGANESE - 3 [hp_X]/59mL OXALIC ACID - 8 [hp_X]/59mL PHYTOLACCA AMERICANA ROOT - 4 [hp_X]/59mL POTASSIUM CHLORIDE - 3 [hp_X]/59mL RICKETTSIA AKARI - 12 [hp_X]/59mL TOXICODENDRON PUBESCENS LEAF - 6 [hp_X]/59mL TREPONEMIC SKIN CANKER HUMAN - 12 [hp_X]/59mL YUCCA FILAMENTOSA WHOLE - 3 [hp_X]/59mL |
| 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: | 09 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: | 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. | |
| UNII: | DTN01M69SN 0MF1EI01KJ O80TY208ZW 1948X6KEG3 0J8NV9V5Q8 76TK29UQEZ DD5FO1WKFU 5ERQ90UTGC 3NJQ5D8S6N ZW3Z11D0JV Load more... 090PL12YZJ XJJ7QA858R HF539G9L3Q 42Z2K6ZL8P 9E7R5L6H31 11E6VI8VEG 660YQ98I10 0M6MOQ3BOU 6IO182RP7A 4ZWP7FWI8W T6VR38UJ9I |
| 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: | Calculi Dissolution Agent [EPC] Increased Large Intestinal Motility [PE] Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] Inhibition Small Intestine Fluid/Electrolyte Absorption [PE] Magnesium Ion Exchange Activity [MoA] Osmotic Activity [MoA] Osmotic Laxative [EPC] Potassium Compounds [CS] Potassium Salt [EPC] Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] |
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. | |
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|---|---|---|---|
| 63083-2128-2 | 59 mL in 1 BOTTLE, DROPPER (63083-2128-2) | 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. | ||||
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