| Drug NDC: | 63479-1412 |
| 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: | N12 Immunosode |
| Also known as the trade name. It is the name of the product chosen by the labeler. | |
| Proprietary Name Base: | N12 |
| The base of the Brand/Proprietary name excluding its suffix. | |
| Proprietary Name Suffix: | IMMUNOSODE |
| 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: | Arsenic Trioxide, Baptisia Tinctoria Root, Sus Scrofa Bone Marrow, Bryonia Alba Root, Echinacea Angustifolia, Echinacea Purpurea, Olea Europaea Flower, Ulex Europaeus, Flower, Lachesis Muta Venom, Levisticum Officinale, Treponemic Skin Canker Human |
| 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: | ARSENIC TRIOXIDE - 30 [hp_X]/mL BAPTISIA TINCTORIA ROOT - 15 [hp_X]/mL BILBERRY - 30 [hp_X]/mL BRYONIA ALBA ROOT - 30 [hp_X]/mL ECHINACEA ANGUSTIFOLIA - 9 [hp_X]/mL ECHINACEA PURPUREA - 9 [hp_X]/mL GONORRHEAL URETHRAL SECRETION HUMAN - 30 [hp_X]/mL LACHESIS MUTA VENOM - 30 [hp_X]/mL LEVISTICUM OFFICINALE - 12 [hp_X]/mL OLEA EUROPAEA FLOWER - 30 [hp_X]/mL Load more... RANCID BEEF - 30 [hp_X]/mL SALMONELLA ENTERICA ENTERICA SEROVAR TYPHI - 60 [hp_X]/mL STAPHYLOCOCCUS EPIDERMIDIS - 30 [hp_X]/mL STAPHYLOCOCCUS HAEMOLYTICUS - 30 [hp_X]/mL STAPHYLOCOCCUS SIMULANS - 30 [hp_X]/mL STREPTOCOCCUS PYOGENES - 30 [hp_X]/mL SULFUR - 30 [hp_X]/mL SUS SCROFA BONE MARROW - 7 [hp_C]/mL SUS SCROFA SPLEEN - 7 [hp_C]/mL THUJA OCCIDENTALIS LEAFY TWIG - 30 [hp_X]/mL TREPONEMIC SKIN CANKER HUMAN - 30 [hp_X]/mL TUBERCULIN PURIFIED PROTEIN DERIVATIVE - 30 [hp_X]/mL ULEX EUROPAEUS FLOWER - 30 [hp_X]/mL VACCINIA VIRUS STRAIN NEW YORK CITY BOARD OF HEALTH LIVE ANTIGEN - 30 [hp_X]/mL VISCUM ALBUM FRUITING TOP - 12 [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: | 04 Dec, 1997 |
| 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: | N0000184316 N0000184315 N0000184306 M0001408 N0000183917 N0000183364 M0019978 M0569003 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | S7V92P67HO 5EF0HWI5WU 9P2U39H18W T7J046YI2B VB06AV5US8 QI7G114Y98 9BZG9E3I8F VSW71SS07I SZD8739PH1 498M34P1VZ Load more... 29SUH5R3HU 760T5R8B3O D5T403TNGE 092IJ99835 V68E0X60VL LJ2LP0YL98 70FD1KFU70 VP2CN2G7Y8 92AMN5J79Y 1NT28V9397 4ZWP7FWI8W I7L8FKN87J 398DBS1PXN 4SV59689SK BK9092J5MP |
| 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: | Skin Test Antigen [EPC] Tuberculosis Skin Test [EPC] Live Vaccinia Virus Vaccine [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: | Cell-mediated Immunity [PE] Actively Acquired 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: | Antigens, Bacterial [CS] Smallpox Vaccine [CS] Vaccines, Live, Unattenuated [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: | Actively Acquired Immunity [PE] Antigens Bacterial [CS] Cell-mediated Immunity [PE] Live Vaccinia Virus Vaccine [EPC] Skin Test Antigen [EPC] Smallpox Vaccine [CS] Tuberculosis Skin Test [EPC] Vaccines Live Unattenuated [CS] |
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. | |
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|---|---|---|---|
| 63479-1412-1 | 30 mL in 1 BOTTLE, GLASS (63479-1412-1) | 04 Dec, 1997 | 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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