| Drug NDC: | 43857-0530 |
| 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: | Bac |
| 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: | Echinacea (angustifolia), Lomatium Dissectum, Myrrha, Nasturtium Aquaticum, Tabebuia Impetiginosa, Hydrastis Canadensis, Propolis, Glandula Suprarenalis Suis, Lymph Node (suis), Spleen (suis), Thymus (suis), Thyroidinum (suis), Arsenicum Album, Belladonna, Hypericum Perforatum, Phosphorus, Botulinum, Escherichia Coli, Proteus (vulgaris), Pseudomonas Aeruginosa, Proteus (morgani), Salmonella Typhi Nosode, Clostridium Perfringens |
| 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: | ARSENIC TRIOXIDE - 12 [hp_X]/mL ATROPA BELLADONNA - 12 [hp_X]/mL BOTULINUM TOXIN TYPE A - 30 [hp_X]/mL CLOSTRIDIUM PERFRINGENS - 15 [hp_C]/mL ECHINACEA ANGUSTIFOLIA - 3 [hp_X]/mL ESCHERICHIA COLI - 30 [hp_X]/mL GOLDENSEAL - 5 [hp_X]/mL HYPERICUM PERFORATUM - 12 [hp_X]/mL LOMATIUM DISSECTUM ROOT - 3 [hp_X]/mL MYRRH - 3 [hp_X]/mL Load more... NASTURTIUM OFFICINALE - 3 [hp_X]/mL PHOSPHORUS - 12 [hp_X]/mL PROPOLIS WAX - 6 [hp_X]/mL PROTEUS MORGANII - 30 [hp_X]/mL PROTEUS VULGARIS - 30 [hp_X]/mL PSEUDOMONAS AERUGINOSA - 30 [hp_X]/mL SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI - 33 [hp_X]/mL SUS SCROFA ADRENAL GLAND - 8 [hp_X]/mL SUS SCROFA LYMPH - 8 [hp_X]/mL SUS SCROFA SPLEEN - 8 [hp_X]/mL SUS SCROFA THYMUS - 8 [hp_X]/mL SUS SCROFA THYROID - 8 [hp_X]/mL TABEBUIA IMPETIGINOSA BARK - 3 [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: | 26 Dec, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 15 May, 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: | 05 May, 2026 |
| 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. | |
| NUI: | N0000175771 N0000193962 N0000175731 N0000175770 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | S7V92P67HO WQZ3G9PF0H E211KPY694 OVP6XX033E VB06AV5US8 514B9K0L10 ZW3Z11D0JV XK4IUX8MNB 5329928G5N JC71GJ1F3L Load more... YH89GMV676 27YLU75U4W 6Y8XYV2NOF 56X6LID5ZY 11T9HCO30O Y793W5V55N 760T5R8B3O 398IYQ16YV 33A7VYU29L 92AMN5J79Y 7B69B0BD62 6RV024OAUQ 6GLA1946WX |
| 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: | Acetylcholine Release Inhibitors [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: | Acetylcholine Release Inhibitor [EPC] Neuromuscular Blocker [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: | Neuromuscular Blockade [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: | Acetylcholine Release Inhibitor [EPC] Acetylcholine Release Inhibitors [MoA] Neuromuscular Blockade [PE] Neuromuscular Blocker [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 |
|---|---|---|---|---|
| 43857-0530-1 | 30 mL in 1 BOTTLE, DROPPER (43857-0530-1) | 26 Dec, 2019 | 15 May, 2025 | 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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