| Drug NDC: | 63479-0208 |
| 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: | B08 Mucous Membranes |
| Also known as the trade name. It is the name of the product chosen by the labeler. | |
| Proprietary Name Base: | B08 |
| The base of the Brand/Proprietary name excluding its suffix. | |
| Proprietary Name Suffix: | MUCOUS MEMBRANES |
| 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: | Balsamum Peruvianum, Borax, Bryonia, Calcarea Acetica, Coccus Cacti, Echinacea Angustifolia, Echinacea Purpurea, Eucalyptus Globulus, Euphorbium Officinarum, Euphrasia Officinalis, Histaminum Hydrochloricum, Ipecacuanha, Kali Bichromicum, Luffa Operculata, Mercurius Cyanatus, Mercurius Dulcis, Mercurius Sulphuratus Ruber, Natrum Arsenicicum, Pancreatinum, Sambucus Nigra, Sanguinarinum Nitricum, Saponaria Officinalis |
| Also known as the generic name, this is usually the active ingredient(s) of the product. | |
| Labeler Name: | Apex Energetics Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. | |
| Dosage Form: | Solution/ Drops |
| 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: | BALSAM PERU - 6 [hp_X]/mL BRYONIA ALBA ROOT - 6 [hp_X]/mL CALCIUM ACETATE - 12 [hp_X]/mL CALOMEL - 12 [hp_X]/mL ECHINACEA ANGUSTIFOLIA - 1 [hp_X]/mL ECHINACEA PURPUREA - 1 [hp_X]/mL EUCALYPTUS GLOBULUS LEAF - 8 [hp_X]/mL EUPHORBIA RESINIFERA RESIN - 6 [hp_X]/mL EUPHRASIA STRICTA - 1 [hp_X]/mL HISTAMINE DIHYDROCHLORIDE - 30 [hp_X]/mL Load more... IPECAC - 10 [hp_X]/mL LUFFA OPERCULATA FRUIT - 12 [hp_X]/mL MERCURIC CYANIDE - 12 [hp_X]/mL MERCURIC SULFIDE - 15 [hp_X]/mL PANCRELIPASE - 4 [hp_C]/mL POTASSIUM DICHROMATE - 12 [hp_X]/mL PROTORTONIA CACTI - 10 [hp_X]/mL SAMBUCUS NIGRA FLOWERING TOP - 12 [hp_X]/mL SANGUINARINE NITRATE - 6 [hp_X]/mL SAPONARIA OFFICINALIS ROOT - 8 [hp_X]/mL SODIUM ARSENATE, DIBASIC, HEPTAHYDRATE - 9 [hp_X]/mL SODIUM BORATE - 6 [hp_X]/mL |
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. | |
| Route Details: | SUBLINGUAL |
| 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 Dec, 1994 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 18 Jun, 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: | Apex Energetics 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: | N0000185508 N0000175629 N0000184306 M0000728 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | 8P5F881OCY T7J046YI2B Y882YXF34X J2D46N657D VB06AV5US8 QI7G114Y98 S546YLW6E6 1TI1O9028K C9642I91WL 3POA0Q644U Load more... 62I3C8233L C4MO6809HU RWG7BD1032 ZI0T668SF1 FQ3DRG0N5K T4423S18FM LZB7TFX1LT CT03BSA18U BOP122S791 RI2K1BMA8B 90ZQ7G407W 91MBZ8H3QO |
| 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 EPC: | Standardized Chemical Allergen [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] |
| 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] |
| 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] Blood Coagulation Factor [EPC] Calcium [CS] Cations Divalent [CS] Cell-mediated Immunity [PE] Increased Coagulation Factor Activity [PE] Increased Histamine Release [PE] Standardized Chemical Allergen [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 |
|---|---|---|---|---|
| 63479-0208-1 | 30 mL in 1 BOTTLE, GLASS (63479-0208-1) | 15 Dec, 1994 | 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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