| Drug NDC: | 62713-956 |
| 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: | Allergena Texas Cedar Fever Tabs |
| Also known as the trade name. It is the name of the product chosen by the labeler. | |
| Proprietary Name Base: | Allergena |
| The base of the Brand/Proprietary name excluding its suffix. | |
| Proprietary Name Suffix: | Texas Cedar Fever Tabs |
| 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: | Allergy Relief |
| Also known as the generic name, this is usually the active ingredient(s) of the product. | |
| Labeler Name: | Meditrend, Inc. Dba Progena Professional Formulations |
| Name of Company corresponding to the labeler code segment of the ProductNDC. | |
| Dosage Form: | Tablet, Orally Disintegrating |
| 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: | ACACIA POLLEN - 30 [hp_X]/1 ACER NEGUNDO POLLEN - 30 [hp_X]/1 ACER RUBRUM POLLEN - 30 [hp_X]/1 ACER SACCHARUM POLLEN - 30 [hp_X]/1 AGROSTIS GIGANTEA POLLEN - 30 [hp_X]/1 ALNUS INCANA SUBSP. RUGOSA POLLEN - 30 [hp_X]/1 ALNUS RUBRA POLLEN - 30 [hp_X]/1 AMARANTHUS PALMERI POLLEN - 30 [hp_X]/1 AMARANTHUS RETROFLEXUS POLLEN - 30 [hp_X]/1 AMBROSIA ARTEMISIIFOLIA POLLEN - 30 [hp_X]/1 Load more... AMBROSIA TRIFIDA POLLEN - 30 [hp_X]/1 ARTEMISIA VULGARIS POLLEN - 30 [hp_X]/1 BACCHARIS HALIMIFOLIA POLLEN - 30 [hp_X]/1 BAPTISIA TINCTORIA ROOT - 3 [hp_X]/1 BETULA LENTA POLLEN - 30 [hp_X]/1 BETULA NIGRA POLLEN - 30 [hp_X]/1 BETULA PAPYRIFERA POLLEN - 30 [hp_X]/1 CARYA ALBA POLLEN - 30 [hp_X]/1 CARYA GLABRA POLLEN - 30 [hp_X]/1 CARYA ILLINOINENSIS POLLEN - 30 [hp_X]/1 CARYA LACINIOSA POLLEN - 30 [hp_X]/1 CARYA OVATA POLLEN - 30 [hp_X]/1 CELTIS OCCIDENTALIS POLLEN - 30 [hp_X]/1 CHENOPODIUM ALBUM POLLEN - 30 [hp_X]/1 CUPRESSUS ARIZONICA POLLEN - 30 [hp_X]/1 CYNODON DACTYLON POLLEN - 30 [hp_X]/1 DACTYLIS GLOMERATA POLLEN - 30 [hp_X]/1 ECHINACEA, UNSPECIFIED - 3 [hp_X]/1 EUCALYPTUS GLOBULUS POLLEN - 30 [hp_X]/1 FAGUS GRANDIFOLIA POLLEN - 30 [hp_X]/1 FENUGREEK LEAF - 3 [hp_X]/1 FESTUCA PRATENSIS POLLEN - 30 [hp_X]/1 FRAXINUS AMERICANA POLLEN - 30 [hp_X]/1 FRAXINUS PENNSYLVANICA POLLEN - 30 [hp_X]/1 FRAXINUS VELUTINA POLLEN - 30 [hp_X]/1 GOLDENSEAL - 3 [hp_X]/1 IVA ANNUA POLLEN - 30 [hp_X]/1 JUGLANS NIGRA POLLEN - 30 [hp_X]/1 JUNIPERUS ASHEI POLLEN - 30 [hp_X]/1 JUNIPERUS PINCHOTII POLLEN - 30 [hp_X]/1 JUNIPERUS VIRGINIANA POLLEN - 30 [hp_X]/1 LIGUSTRUM VULGARE POLLEN - 30 [hp_X]/1 LIQUIDAMBAR STYRACIFLUA POLLEN - 30 [hp_X]/1 LOLIUM PERENNE POLLEN - 30 [hp_X]/1 MORELLA CERIFERA POLLEN - 30 [hp_X]/1 MORUS RUBRA POLLEN - 30 [hp_X]/1 MYRRH - 3 [hp_X]/1 NASTURTIUM OFFICINALE - 3 [hp_X]/1 PASPALUM NOTATUM POLLEN - 30 [hp_X]/1 PHOENIX DACTYLIFERA POLLEN - 30 [hp_X]/1 PHYTOLACCA AMERICANA ROOT - 3 [hp_X]/1 PINUS STROBUS POLLEN - 30 [hp_X]/1 PLANTAGO LANCEOLATA POLLEN - 30 [hp_X]/1 PLATANUS OCCIDENTALIS POLLEN - 30 [hp_X]/1 POA PRATENSIS POLLEN - 30 [hp_X]/1 POPULUS ALBA POLLEN - 30 [hp_X]/1 POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN - 30 [hp_X]/1 POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN - 30 [hp_X]/1 POPULUS TREMULOIDES POLLEN - 30 [hp_X]/1 PSEUDOTSUGA MENZIESII POLLEN - 30 [hp_X]/1 QUERCUS ALBA POLLEN - 30 [hp_X]/1 QUERCUS RUBRA POLLEN - 30 [hp_X]/1 QUERCUS VIRGINIANA POLLEN - 30 [hp_X]/1 ROBINIA PSEUDOACACIA POLLEN - 30 [hp_X]/1 RUMEX CRISPUS POLLEN - 30 [hp_X]/1 SALIX NIGRA POLLEN - 30 [hp_X]/1 SORGHUM HALEPENSE POLLEN - 30 [hp_X]/1 TAXODIUM DISTICHUM POLLEN - 30 [hp_X]/1 ULMUS AMERICANA POLLEN - 30 [hp_X]/1 ULMUS CRASSIFOLIA POLLEN - 30 [hp_X]/1 ULMUS PUMILA POLLEN - 30 [hp_X]/1 ULMUS RUBRA POLLEN - 30 [hp_X]/1 URTICA DIOICA POLLEN - 30 [hp_X]/1 XANTHIUM STRUMARIUM POLLEN - 30 [hp_X]/1 |
| 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: | 15 Mar, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 08 May, 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: | Meditrend, Inc. DBA Progena Professional Formulations |
| 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 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | 43DDR2YDYZ P6K070AR8V 700NK45C76 V38QUQ7861 HU8V6E7HOA 605T96G8Y5 Z0F2YK1B7H 1GH3WV23KH 73B14PX5FW K20Y81ACO3 Load more... KU1V1898XX ANT994T71D BBO1IJ3ZIW 5EF0HWI5WU JQ5HI5004M 93963RFO1P 3538FNV8AY G2A764T54B KPO1Z9N98A PYO4JR720Y 5BGG872373 54UN9R2798 68R9X9Y96X 098LKX5NCN 232DMH0XVF 175F461W10 83N78IDA7P 4N9P6CC1DX 7XW7TB10X9 34X886W1H4 487RI96K8Z A0WFQ8P6N1 G684LX721Q 2WZG2G15WX LJT6I6Z8FD ZW3Z11D0JV Y2U5S5PF22 1BV28146ZR 544F8MEY0Y S8A4X05W7J PY0JA16R2G Y3FRX92Z0E 5Q246DS5BS 4T81LB52R0 LC8MEV9S89 9LYI4RTZ52 JC71GJ1F3L YH89GMV676 V003SHB7VK 2FV55IRB5B 11E6VI8VEG TX1ER5UV3T DO87T1U2CI E03U1K03LK SCB8J7LS3T VU8C8SB23P 476DVV63WP 5928LJ1441 928OC2TJDA ZEI09763J3 Z4Y9ZSV4KK SVW19ET93C 8KDG09A4GO 8003NOJ82F V825XJG64G 6M2JIH93ZN 577VA5B4HP O12H03B41R 89BAT511BD G82398SD3I 030R993R8E GHC6OHK0W0 DNB59M1NVU 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] |
| 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] |
| 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] Increased Histamine Release [PE] |
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. | |
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|---|---|---|---|
| 62713-956-01 | 90 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (62713-956-01) | 15 Mar, 2021 | 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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