Drug NDC: | 62713-809 |
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 Zone 9 |
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: | Zone 9 |
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: | Echinacea,baptisia Tinctoria, Hydrastis Canadensis, Myrrha, Nasturtium Aquaticum, Phytolacca Decandra, Trigonella Foenum-graecum, Zone 9 Tree, Zone 9 Weed, Zone 9 Grass |
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: | 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: | ACACIA POLLEN - 30 [hp_X]/mL AGROSTIS GIGANTEA POLLEN - 30 [hp_X]/mL AILANTHUS ALTISSIMA POLLEN - 30 [hp_X]/mL ALNUS INCANA SUBSP. RUGOSA POLLEN - 30 [hp_X]/mL AMARANTHUS PALMERI POLLEN - 30 [hp_X]/mL AMARANTHUS RETROFLEXUS POLLEN - 30 [hp_X]/mL AMBROSIA ACANTHICARPA POLLEN - 30 [hp_X]/mL AMBROSIA PSILOSTACHYA POLLEN - 30 [hp_X]/mL ATRIPLEX CANESCENS POLLEN - 30 [hp_X]/mL BAPTISIA TINCTORIA ROOT - 3 [hp_X]/mL Load more... BROMUS INERMIS POLLEN - 30 [hp_X]/mL BROMUS SECALINUS POLLEN - 30 [hp_X]/mL CHENOPODIUM ALBUM POLLEN - 30 [hp_X]/mL CYNODON DACTYLON POLLEN - 30 [hp_X]/mL DACTYLIS GLOMERATA POLLEN - 30 [hp_X]/mL ECHINACEA, UNSPECIFIED - 3 [hp_X]/mL EUCALYPTUS GLOBULUS POLLEN - 30 [hp_X]/mL FENUGREEK LEAF - 3 [hp_X]/mL FESTUCA PRATENSIS POLLEN - 30 [hp_X]/mL FRAXINUS VELUTINA POLLEN - 30 [hp_X]/mL GOLDENSEAL - 3 [hp_X]/mL JUGLANS NIGRA POLLEN - 30 [hp_X]/mL JUNIPERUS SCOPULORUM POLLEN - 30 [hp_X]/mL LIGUSTRUM VULGARE POLLEN - 30 [hp_X]/mL LIQUIDAMBAR STYRACIFLUA POLLEN - 30 [hp_X]/mL LOLIUM PERENNE POLLEN - 30 [hp_X]/mL MORUS ALBA POLLEN - 30 [hp_X]/mL MYRRH - 3 [hp_X]/mL NASTURTIUM OFFICINALE - 3 [hp_X]/mL OLEA EUROPAEA POLLEN - 30 [hp_X]/mL PHLEUM PRATENSE POLLEN - 30 [hp_X]/mL PHOENIX DACTYLIFERA POLLEN - 30 [hp_X]/mL PHYTOLACCA AMERICANA ROOT - 3 [hp_X]/mL PINUS STROBUS POLLEN - 30 [hp_X]/mL PLANTAGO LANCEOLATA POLLEN - 30 [hp_X]/mL PLATANUS OCCIDENTALIS POLLEN - 30 [hp_X]/mL POA PRATENSIS POLLEN - 30 [hp_X]/mL POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN - 30 [hp_X]/mL PROSOPIS JULIFLORA POLLEN - 30 [hp_X]/mL QUERCUS AGRIFOLIA POLLEN - 30 [hp_X]/mL RUMEX CRISPUS POLLEN - 30 [hp_X]/mL SALIX NIGRA POLLEN - 30 [hp_X]/mL SALSOLA TRAGUS POLLEN - 30 [hp_X]/mL SORGHUM HALEPENSE POLLEN - 30 [hp_X]/mL ULMUS CRASSIFOLIA POLLEN - 30 [hp_X]/mL ULMUS PUMILA POLLEN - 30 [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 Jan, 1987 |
This is the date that the labeler indicates was the start of its marketing of the drug product. | |
Marketing End Date: | 19 May, 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: | 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 HU8V6E7HOA 2A64U81OQ3 605T96G8Y5 1GH3WV23KH 73B14PX5FW U2AI3H2J5Y RX18M46K8L 26U0BU8G83 5EF0HWI5WU Load more... 766QT72BK6 Q4T1SJ3046 098LKX5NCN 175F461W10 83N78IDA7P 4N9P6CC1DX 7XW7TB10X9 487RI96K8Z A0WFQ8P6N1 LJT6I6Z8FD ZW3Z11D0JV 1BV28146ZR 0G82TT8ZFY Y3FRX92Z0E 5Q246DS5BS 4T81LB52R0 3I9T68187H JC71GJ1F3L YH89GMV676 43R41XZ627 65M88RW2EG 2FV55IRB5B 11E6VI8VEG TX1ER5UV3T DO87T1U2CI E03U1K03LK SCB8J7LS3T 5928LJ1441 6EIJ3D04MR VOT5MA71M7 V825XJG64G 6M2JIH93ZN V174354MDI 577VA5B4HP G82398SD3I 030R993R8E |
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] Increased IgG Production [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 |
---|---|---|---|---|
62713-809-01 | 30 mL in 1 BOTTLE, DROPPER (62713-809-01) | 01 Jan, 1987 | N/A | No |
62713-809-02 | 59 mL in 1 BOTTLE, DROPPER (62713-809-02) | 01 Jan, 1987 | 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. |
* 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.