| Drug NDC: | 44911-0361 |
| 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: | Vegetable Antigens |
| 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: | Allium Cepa, Allium Sativum, Apium Graveolens, Beta Vulgaris, Brassica Oleracea Var. Botrytis, Brassica Oleracea Var. Capitata, Brassica Oleracea Var. Italica, Brassica Oleracea Var. Sabellica, Brassica Rapa Var. Rapa, Cicer Arietinum, Cucumis Staivus, Glycine Max, Lactuca Sativa, Lens Culinaris, Pastinaca Sativa, Phaseolus, Phaseolus Lunatus, Phaseolus Vulgaris, Raphanus Sativus, Spinacia Oleracea, Arsenicum Album, Bryonia (alba), Helleborus Niger, Lycopodium Clavatum, Petroleum |
| 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: | ARSENIC TRIOXIDE - 12 [hp_X]/mL BEET - 12 [hp_X]/mL BROCCOLI - 12 [hp_X]/mL BRYONIA ALBA ROOT - 12 [hp_X]/mL CABBAGE - 12 [hp_X]/mL CAULIFLOWER - 12 [hp_X]/mL CELERY SEED - 12 [hp_X]/mL CHICKPEA - 12 [hp_X]/mL CUCUMBER - 12 [hp_X]/mL GARLIC - 12 [hp_X]/mL Load more... HELLEBORUS NIGER ROOT - 12 [hp_X]/mL KALE - 12 [hp_X]/mL KEROSENE - 12 [hp_X]/mL KIDNEY BEAN - 12 [hp_X]/mL LENTIL - 12 [hp_X]/mL LETTUCE - 12 [hp_X]/mL LIMA BEAN - 12 [hp_X]/mL LYCOPODIUM CLAVATUM SPORE - 12 [hp_X]/mL ONION - 12 [hp_X]/mL PARSNIP - 12 [hp_X]/mL RADISH - 12 [hp_X]/mL SOYBEAN - 12 [hp_X]/mL SPINACH - 12 [hp_X]/mL STRING BEAN - 12 [hp_X]/mL TURNIP - 12 [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: | 01 Jun, 2016 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 10 Feb, 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: | 09 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. | |
| UPC: | 0363113700183 |
| UPC stands for Universal Product Code. | |
| NUI: | N0000185375 N0000185371 N0000175629 N0000184306 M0000728 M0006342 M0016962 M0022575 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | S7V92P67HO N487KM8COK UOI4FT57BZ T7J046YI2B GW0W1Y9I97 138LUT2DWV 1G1EAA320L N91637DNW9 YY7C30VXJT V1V998DC17 Load more... 608DGJ6815 0Y3L4J38H1 1C89KKC04E M98C8416QO 6O38V6B52O 5PO6NN3RRJ 112YH1ZMX2 C88X29Y479 492225Q21H L2V28YP49S EM5RP35463 L7HT8F1ZOD 6WO75C6WVB N9D69B2Q7Y Z38C7FBM49 |
| 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 Plant Allergenic Extract [EPC] Non-Standardized Food Allergenic Extract [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] Dietary Proteins [CS] Plant Proteins [CS] Vegetable Proteins [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] Cell-mediated Immunity [PE] Dietary Proteins [CS] Increased Histamine Release [PE] Non-Standardized Food Allergenic Extract [EPC] Non-Standardized Plant Allergenic Extract [EPC] Plant Proteins [CS] Vegetable Proteins [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 |
|---|---|---|---|---|
| 44911-0361-1 | 30 mL in 1 BOTTLE, DROPPER (44911-0361-1) | 01 Jun, 2016 | 10 Feb, 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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