| Drug NDC: | 63083-9239 |
| 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: | Pyrogenium Combination 9239 |
| Also known as the trade name. It is the name of the product chosen by the labeler. | |
| Proprietary Name Base: | Pyrogenium Combination |
| The base of the Brand/Proprietary name excluding its suffix. | |
| Proprietary Name Suffix: | 9239 |
| 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: | Pyrogenium Combination |
| Also known as the generic name, this is usually the active ingredient(s) of the product. | |
| Labeler Name: | Professional Complementary Health Formulas |
| 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: | ANHYDROUS DIBASIC CALCIUM PHOSPHATE - 10 [hp_X]/29.5mL ANTIMONY POTASSIUM TARTRATE - 6 [hp_X]/29.5mL ASCORBIC ACID - 3 [hp_X]/29.5mL BARIUM CARBONATE - 28 [hp_X]/29.5mL BEEF KIDNEY - 13 [hp_X]/29.5mL BEEF LIVER - 10 [hp_X]/29.5mL BOS TAURUS HYPOTHALAMUS - 10 [hp_X]/29.5mL BOS TAURUS LYMPH VESSEL - 10 [hp_X]/29.5mL BOS TAURUS SPLEEN - 10 [hp_X]/29.5mL BOS TAURUS TONSIL - 28 [hp_X]/29.5mL Load more... CONIUM MACULATUM FLOWERING TOP - 4 [hp_X]/29.5mL CORTISONE ACETATE - 13 [hp_X]/29.5mL ECHINACEA ANGUSTIFOLIA WHOLE - 4 [hp_X]/29.5mL FERROSOFERRIC PHOSPHATE - 10 [hp_X]/29.5mL GALIUM APARINE WHOLE - 6 [hp_X]/29.5mL GENTIANA LUTEA ROOT - 6 [hp_X]/29.5mL GERANIUM ROBERTIANUM WHOLE - 6 [hp_X]/29.5mL HORSE CHESTNUT - 6 [hp_X]/29.5mL LACTIC ACID, DL- - 6 [hp_X]/29.5mL MERCURIUS SOLUBILIS - 13 [hp_X]/29.5mL PROTORTONIA CACTI - 6 [hp_X]/29.5mL PULSATILLA MONTANA WHOLE - 6 [hp_X]/29.5mL RANCID BEEF - 198 [hp_X]/29.5mL SCABIES LESION LYSATE (HUMAN) - 28 [hp_X]/29.5mL SOLANUM DULCAMARA WHOLE - 4 [hp_X]/29.5mL SULFUR - 8 [hp_X]/29.5mL SUS SCROFA BONE MARROW - 10 [hp_X]/29.5mL THYROID, UNSPECIFIED - 13 [hp_X]/29.5mL |
| 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 Aug, 1984 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 24 Dec, 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: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. | |
| Manufacturer Name: | Professional Complementary Health Formulas |
| 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: | N0000193618 M0001797 N0000185371 N0000175629 N0000184306 M0000728 M0006342 N0000185017 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | L11K75P92J DL6OZ476V3 PQ6CK8PD0R 6P669D8HQ8 5HOC10FSIC W8N8R55022 S6G2NLH4Y7 85I1Z426OV 190Q9MB3U3 12SEC09GR1 Load more... Q28R5GF371 883WKN7W8X VB06AV5US8 91GQH8I5F7 Z4B6561488 S72O3284MS R5I1HK0UBL 3C18L6RJAZ 3B8D35Y7S4 324Y4038G2 LZB7TFX1LT 24K790T39B 29SUH5R3HU 5UAU16Z1U4 G72JA9DHK5 70FD1KFU70 VP2CN2G7Y8 0B4FDL9I6P |
| 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: | Vitamin C [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: | Ascorbic Acid [CS] Allergens [CS] Dietary 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] Ascorbic Acid [CS] Cell-mediated Immunity [PE] Corticosteroid Hormone Receptor Agonists [MoA] Corticosteroid [EPC] Dietary Proteins [CS] Increased Histamine Release [PE] Meat Proteins [EXT] Non-Standardized Food Allergenic Extract [EPC] Vitamin C [EPC] |
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. | |
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|---|---|---|---|
| 63083-9239-1 | 29.5 mL in 1 BOTTLE, DROPPER (63083-9239-1) | 15 Aug, 1985 | 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.