| Drug NDC: | 44911-0016 |
| 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: | Weed Grass 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, Arsenicum Album, Nux Vomica, Pulsatilla (vulgaris), Alfalfa, Amaranthus Hybridus, Bamboo (leaf), Agrimonia Eupatorium, Taraxacum Officinale, Solidago Virguarea, Kentucky Blue, Lamb's Quarter, Marsh Elder (combination), Meadow Fescue, Artemisia Vulgaris, Orchard, Perennial Rye, Trifolium Pratense, Redtop, Rough Pigweed, Sagebrush, Spiny Pigweed, Sweet Vernal, Timothy, Western Ragweed, Trifolium Repens, Rumex Crispus And Sorrel (combination) |
| 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: | AGROSTIS STOLONIFERA POLLEN - 12 [hp_X]/mL ALFALFA - 12 [hp_X]/mL AMARANTHUS PALMERI POLLEN - 12 [hp_X]/mL AMARANTHUS RETROFLEXUS POLLEN - 12 [hp_X]/mL AMARANTHUS SPINOSUS POLLEN - 12 [hp_X]/mL AMBROSIA PSILOSTACHYA POLLEN - 12 [hp_X]/mL ANTHOXANTHUM ODORATUM POLLEN - 12 [hp_X]/mL ARSENIC TRIOXIDE - 12 [hp_X]/mL ARTEMISIA TRIDENTATA POLLEN - 12 [hp_X]/mL ARTEMISIA VULGARIS POLLEN - 12 [hp_X]/mL Load more... BAMBUSA VULGARIS LEAF - 12 [hp_X]/mL CHENOPODIUM ALBUM POLLEN - 12 [hp_X]/mL DACTYLIS GLOMERATA POLLEN - 12 [hp_X]/mL FESTUCA PRATENSIS POLLEN - 12 [hp_X]/mL IVA ANGUSTIFOLIA POLLEN - 12 [hp_X]/mL IVA ANNUA POLLEN - 12 [hp_X]/mL LOLIUM PERENNE POLLEN - 12 [hp_X]/mL ONION - 12 [hp_X]/mL PHLEUM PRATENSE POLLEN - 12 [hp_X]/mL POA PRATENSIS POLLEN - 12 [hp_X]/mL PULSATILLA VULGARIS - 12 [hp_X]/mL RED CLOVER - 12 [hp_X]/mL RUMEX ACETOSELLA POLLEN - 12 [hp_X]/mL RUMEX CRISPUS POLLEN - 12 [hp_X]/mL SOLIDAGO VIRGAUREA FLOWERING TOP - 12 [hp_X]/mL STRYCHNOS NUX-VOMICA SEED - 12 [hp_X]/mL TARAXACUM OFFICINALE WHOLE - 12 [hp_X]/mL TRIFOLIUM REPENS FLOWER - 12 [hp_X]/mL XANTHIUM STRUMARIUM POLLEN - 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: | 16 Aug, 2012 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 07 Nov, 2023 |
| 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: | 24 Jun, 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: | N0000185367 N0000175629 N0000184306 N0000185001 M0017130 M0000728 N0000185006 N0000185371 M0006342 M0022575 N0000185375 M0016962 M0516536 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | 255H8VT4RK DJO934BRBD 1GH3WV23KH 73B14PX5FW 380W4HYR6N RX18M46K8L 2KIK19R45Y S7V92P67HO YI19RB8YFD ANT994T71D Load more... EMY54R518C 098LKX5NCN 83N78IDA7P A0WFQ8P6N1 UBW6O1H50I Y2U5S5PF22 4T81LB52R0 492225Q21H 65M88RW2EG SCB8J7LS3T I76KB35JEV L9153EKV2Y N52MIQ81ZW V825XJG64G 5405K23S50 269XH13919 7C42E2D7B0 49Y788T742 2QOF601J1M |
| 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 Pollen Allergenic Extract [EPC] Standardized Pollen Allergenic Extract [EPC] Non-Standardized Food Allergenic Extract [EPC] Non-Standardized Plant 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] Increased IgG Production [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: | Pollen [CS] Allergens [CS] Dietary Proteins [CS] Vegetable Proteins [CS] Plant Proteins [CS] Seed Storage 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] Increased IgG Production [PE] Non-Standardized Food Allergenic Extract [EPC] Non-Standardized Plant Allergenic Extract [EPC] Non-Standardized Pollen Allergenic Extract [EPC] Plant Proteins [CS] Pollen [CS] Seed Storage Proteins [CS] Standardized Pollen Allergenic Extract [EPC] 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 |
|---|---|---|---|---|
| 44911-0016-1 | 30 mL in 1 BOTTLE, DROPPER (44911-0016-1) | 16 Aug, 2012 | 07 Nov, 2023 | 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. | ||||