| Drug NDC: | 43857-0628 |
| 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: | Lymph Iii |
| Also known as the trade name. It is the name of the product chosen by the labeler. | |
| Proprietary Name Base: | Lymph |
| The base of the Brand/Proprietary name excluding its suffix. | |
| Proprietary Name Suffix: | III |
| 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: | Echinacea (angustifolia), Boldo, Phytolacca Decandra, Pinus Sylvestris, Thyroidinum (suis), Germanium Sesquioxide, Arnica Montana, Calcarea Iodata, Hamamelis Virginiana, Hepar Sulphuris Calcareum, Adenosinum Triphosphoricum Dinatrum, Ubidecarenonum, Naja Tripudians, Calcarea Phosphorica, Influenzinum (2022-2023), Natrum Sulphuricum, Pyrogenium, Sulphur, Carcinosin |
| Also known as the generic name, this is usually the active ingredient(s) of the product. | |
| Labeler Name: | Bioactive Nutritional, Inc. |
| 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: | ADENOSINE TRIPHOSPHATE DISODIUM - 12 [hp_X]/mL ARNICA MONTANA WHOLE - 12 [hp_X]/mL CALCIUM IODIDE - 12 [hp_X]/mL CALCIUM SULFIDE - 12 [hp_X]/mL ECHINACEA ANGUSTIFOLIA WHOLE - 1 [hp_X]/mL GERMANIUM SESQUIOXIDE - 8 [hp_X]/mL HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - 12 [hp_X]/mL HUMAN BREAST TUMOR CELL - 200 [hp_X]/mL INFLUENZA A VIRUS A/DARWIN/9/2021 IVR-228 (H3N2) ANTIGEN (UV, FORMALDEHYDE INACTIVATED) - 30 [hp_X]/mL INFLUENZA A VIRUS A/VICTORIA/2570/2019 IVR-215 (H1N1) ANTIGEN (UV, FORMALDEHYDE INACTIVATED) - 30 [hp_X]/mL Load more... INFLUENZA B VIRUS B/AUSTRIA/1359417/2021 BVR-26 ANTIGEN (UV, FORMALDEHYDE INACTIVATED) - 30 [hp_X]/mL INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (UV, FORMALDEHYDE INACTIVATED) - 30 [hp_X]/mL NAJA NAJA VENOM - 15 Ci/mL PEUMUS BOLDUS LEAF - 3 [hp_X]/mL PHYTOLACCA AMERICANA ROOT - 4 [hp_X]/mL PINUS SYLVESTRIS LEAFY TWIG - 6 [hp_X]/mL RANCID BEEF - 30 [hp_X]/mL SODIUM SULFATE - 30 [hp_X]/mL SULFUR - 30 [hp_X]/mL THYROID, PORCINE - 6 [hp_X]/mL TRIBASIC CALCIUM PHOSPHATE - 30 [hp_X]/mL UBIDECARENONE - 12 [hp_X]/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: | 22 Nov, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 23 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: | BioActive Nutritional, Inc. |
| 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: | 5L51B4DR1G O80TY208ZW 8EKI9QEE2H 1MBW07J51Q VB06AV5US8 96WE91N25T T7S323PKJS C62OO7VD9K P483J7GX6D 34C49NV47P Load more... TBV2PPG6EF H2198F8ZNA ZZ4AG7L7VM Q4EWM09M3O 11E6VI8VEG Q1RGP4UB73 29SUH5R3HU 0YPR65R21J 70FD1KFU70 6RV024OAUQ 91D9GV0Z28 EJ27X76M46 |
| 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: | Blood Coagulation Factor [EPC] Calcium [CS] Cations Divalent [CS] Increased Coagulation Factor Activity [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 |
|---|---|---|---|---|
| 43857-0628-1 | 60 mL in 1 BOTTLE, DROPPER (43857-0628-1) | 22 Nov, 2022 | 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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