| Drug NDC: | 44911-0481 |
| 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: | Bio-immune |
| 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: | Chelidonium Majus, Lobelia Inflata, Rumex Crispus, Sambucus Nigra, Scrophularia Nodosa, Senega Officinalis, Spongia Tosta, Taraxacum Officinale, Myristica Sebifera, Sticta Pulmonaria, Sulphur, Ustilago Maidis, Polyporus Officinalis, Candida Albicans, Carduus Marianus, Crotalus Horridus, Agaricus Muscarius, Bovista, Secale Cornutum, Anas Barbariae, Hepatis Et Cordis Extractum, Anthracinum, Arsenicum Album, Baptisia Tinctoria, Berberis Vulgaris, Botulinum, Dysentery Bacillus, Gaertner Bacillus (bach), |
| Also known as the generic name, this is usually the active ingredient(s) of the product. | |
| Labeler Name: | Energique, 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: | AMANITA MUSCARIA FRUITING BODY - 10 [hp_C]/mL ARSENIC TRIOXIDE - 30 [hp_C]/mL BACILLUS ANTHRACIS IMMUNOSERUM RABBIT - 30 [hp_C]/mL BAPTISIA TINCTORIA ROOT - 30 [hp_C]/mL BERBERIS VULGARIS ROOT BARK - 30 [hp_C]/mL CAIRINA MOSCHATA HEART/LIVER AUTOLYSATE - 30 [hp_C]/mL CANDIDA ALBICANS - 12 [hp_X]/mL CHELIDONIUM MAJUS - 3 [hp_X]/mL CLAVICEPS PURPUREA SCLEROTIUM - 10 [hp_C]/mL CLOSTRIDIUM BOTULINUM - 30 [hp_C]/mL Load more... CROTALUS HORRIDUS HORRIDUS VENOM - 12 [hp_X]/mL HUMAN SPUTUM, BORDETELLA PERTUSSIS INFECTED - 30 [hp_C]/mL INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED) - 30 [hp_C]/mL INFLUENZA A VIRUS A/SINGAPORE/INFIMH-16-0019/2016 NIB-104 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED) - 30 [hp_C]/mL INFLUENZA B VIRUS B/MARYLAND/15/2016 ANTIGEN (FORMALDEHYDE INACTIVATED) - 30 [hp_C]/mL INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED) - 30 [hp_C]/mL LARICIFOMES OFFICINALIS FRUITING BODY - 8 [hp_X]/mL LOBARIA PULMONARIA - 6 [hp_X]/mL LOBELIA INFLATA - 3 [hp_X]/mL LYCOPERDON UTRIFORME FRUITING BODY - 10 [hp_C]/mL MILK THISTLE - 12 [hp_X]/mL POLYGALA SENEGA ROOT - 3 [hp_X]/mL RANCID BEEF - 30 [hp_C]/mL RUMEX CRISPUS ROOT - 3 [hp_X]/mL SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS - 30 [hp_C]/mL SAMBUCUS NIGRA FLOWERING TOP - 3 [hp_X]/mL SCROPHULARIA NODOSA - 3 [hp_X]/mL SHIGELLA DYSENTERIAE - 30 [hp_C]/mL SPONGIA OFFICINALIS SKELETON, ROASTED - 3 [hp_X]/mL STREPTOCOCCUS PNEUMONIAE - 30 [hp_C]/mL SULFUR - 6 [hp_X]/mL TARAXACUM OFFICINALE - 3 [hp_X]/mL USTILAGO MAYDIS - 6 [hp_X]/mL VACCINIA VIRUS - 30 [hp_C]/mL VACCINIA VIRUS STRAIN NEW YORK CITY BOARD OF HEALTH LIVE ANTIGEN - 30 [hp_C]/mL VIROLA SEBIFERA RESIN - 6 [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: | 09 Nov, 2018 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 06 Mar, 2024 |
| 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: | 07 May, 2026 |
| This is the date when the listing record will expire if not updated or certified by the firm. | |
| Manufacturer Name: | Energique, 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: | N0000185372 N0000175629 N0000184306 N0000185001 M0008890 M0000728 N0000183917 N0000183364 M0019978 M0569003 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | DIF093I037 S7V92P67HO 41LZ22DD4N 5EF0HWI5WU 1TH8Q20J0U RN2HC612GY 4D7G21HDBC 7E889U5RNN 01G9XEA93N 0296055VE0 Load more... YHA2XLJ956 U364V64HUN Q3P251C5MT 2ZSC17SIJ6 8V4458342X B93BQX9789 7IFM8431X3 D1YM0P5Z2T 9PP1T3TC5U K2A74U428F U946SH95EE M7T6H7D4IF 29SUH5R3HU 9N1RM2S62C Y3V16D4PV4 CT03BSA18U 7H443NUB2T 1EP6R5562J 1PIP394IID BT6U234YR2 70FD1KFU70 39981FM375 4K7Z7K7SWG JDS6958QAG 4SV59689SK GHJ5XX5SGS |
| 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: | Non-Standardized Fungal Allergenic Extract [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: | Increased Histamine Release [PE] Cell-mediated Immunity [PE] Increased IgG Production [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: | Fungal Proteins [CS] Allergens [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] Allergens [CS] Cell-mediated Immunity [PE] Fungal Proteins [CS] Increased Histamine Release [PE] Increased IgG Production [PE] Live Vaccinia Virus Vaccine [EPC] Non-Standardized Fungal Allergenic Extract [EPC] Smallpox Vaccine [CS] 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 |
|---|---|---|---|---|
| 44911-0481-1 | 30 mL in 1 BOTTLE, DROPPER (44911-0481-1) | 09 Nov, 2018 | 06 Mar, 2024 | 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. | ||||
* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.