| Drug NDC: | 43742-0701 |
| 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: | B Complex Mix System Formula |
| 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: | Magnesium Orotate, Beta Vulgaris, Ascorbic Acid, Citricum Acidum, Cysteinum, Pulsatilla (vulgaris), Adenine, Amygdalin, Adenosinum Triphosphoricum Dinatrum, Cholinum, Cyanocobalamin, Folic Acid, Inositol, Niacin, P-aminobenzoic Acid, Pangamic Acid, Pantothenic Acid, Pyridoxinum Hydrochloricum, Riboflavinum, Sulphur, Thiaminum Hydrochloricum, Natrum Oxalaceticum, Oroticum Acidum, Manganum Phosphoricum, Mutabile Bacillus (bach), Morgan Bacillus (pure) |
| Also known as the generic name, this is usually the active ingredient(s) of the product. | |
| Labeler Name: | Deseret Biologicals, 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: | ADENINE - 6 [hp_C]/mL ADENOSINE TRIPHOSPHATE DISODIUM - 6 [hp_C]/mL AMINOBENZOIC ACID - 6 [hp_C]/mL AMYGDALIN - 6 [hp_C]/mL ANHYDROUS CITRIC ACID - 4 [hp_C]/mL ASCORBIC ACID - 3 [hp_C]/mL BETA VULGARIS - 2 [hp_C]/mL CHOLINE HYDROXIDE - 6 [hp_C]/mL CYANOCOBALAMIN - 6 [hp_C]/mL CYSTEINE - 4 [hp_C]/mL Load more... ESCHERICHIA COLI - 30 [hp_C]/mL FOLIC ACID - 6 [hp_C]/mL INOSITOL - 6 [hp_C]/mL MAGNESIUM OROTATE - 12 [hp_X]/mL MANGANESE PHOSPHATE, DIBASIC - 10 [hp_C]/mL NIACIN - 6 [hp_C]/mL OROTIC ACID MONOHYDRATE - 8 [hp_C]/mL PANGAMIC ACID - 6 [hp_C]/mL PANTOTHENIC ACID - 6 [hp_C]/mL PROTEUS MORGANII - 30 [hp_C]/mL PULSATILLA VULGARIS - 4 [hp_C]/mL PYRIDOXINE HYDROCHLORIDE - 6 [hp_C]/mL RIBOFLAVIN - 6 [hp_C]/mL SODIUM DIETHYL OXALACETATE - 7 [hp_C]/mL SULFUR - 6 [hp_C]/mL THIAMINE HYDROCHLORIDE - 6 [hp_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: | 22 Dec, 2015 |
| 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: | Deseret Biologicals, 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: | M0022792 N0000175714 N0000175833 N0000175835 N0000175980 N0000008556 N0000175089 N0000193618 M0001797 M0022794 N0000175951 N0000175594 M0014839 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | JAC85A2161 5L51B4DR1G TL2TJE8QTX 214UUQ9N0H XF417D3PSL PQ6CK8PD0R 4G174V5051 7THJ3EG9SY P6YC3EG204 K848JZ4886 Load more... 514B9K0L10 935E97BOY8 4L6452S749 GI96W46M5A VZ3U1H7Q5B 2679MF687A 91532S02AO MPQ53A9F5C 19F5HK2737 56X6LID5ZY I76KB35JEV 68Y4CF58BV TLM2976OFR 6CA025Y4FG 70FD1KFU70 M572600E5P |
| 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: | Acidifying Activity [MoA] Calcium Chelating 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: | Vitamin B Complex Member [EPC] Calculi Dissolution Agent [EPC] Anti-coagulant [EPC] Vitamin C [EPC] Vitamin B12 [EPC] Nicotinic Acid [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: | Decreased Coagulation Factor Activity [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: | Vitamin B Complex [CS] Ascorbic Acid [CS] Vitamin B 12 [CS] Nicotinic Acids [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: | Acidifying Activity [MoA] Analogs/Derivatives [Chemical/Ingredient] Anti-coagulant [EPC] Ascorbic Acid [CS] Calcium Chelating Activity [MoA] Calculi Dissolution Agent [EPC] Decreased Coagulation Factor Activity [PE] Magnetic Resonance Contrast Activity [MoA] Nicotinic Acid [EPC] Nicotinic Acids [CS] Paramagnetic Contrast Agent [EPC] Vitamin B 12 [CS] Vitamin B 6 [Chemical/Ingredient] Vitamin B Complex Member [EPC] Vitamin B Complex [CS] Vitamin B12 [EPC] Vitamin B6 Analog [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 |
|---|---|---|---|---|
| 43742-0701-1 | 30 mL in 1 BOTTLE, DROPPER (43742-0701-1) | 01 Jun, 2016 | 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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