| Drug NDC: | 63083-6017 |
| 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: | Viral Immune Stimulator 6017 |
| Also known as the trade name. It is the name of the product chosen by the labeler. | |
| Proprietary Name Base: | Viral Immune Stimulator |
| The base of the Brand/Proprietary name excluding its suffix. | |
| Proprietary Name Suffix: | 6017 |
| 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: | Viral Immune Stimulator |
| 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: | ASCLEPIAS TUBEROSA FLOWERING TOP - 3 [hp_X]/59mL BACILLUS CALMETTE-GUERIN LIVE ANTIGEN, UNSPECIFIED SUBSTRAIN - 30 [hp_X]/59mL CALCIUM ARSENATE - 12 [hp_X]/59mL CAMPHOR (NATURAL) - 12 [hp_X]/59mL COW MILK - 6 [hp_X]/59mL COXSACKIEVIRUS A21 - 30 [hp_X]/59mL CYNANCHUM OTOPHYLLUM WHOLE - 30 [hp_X]/59mL ECHINACEA PURPUREA WHOLE - 3 [hp_X]/59mL EUPHRASIA STRICTA - 6 [hp_X]/59mL FERROUS IODIDE - 8 [hp_X]/59mL Load more... HUMAN HERPESVIRUS 1 - 30 [hp_X]/59mL HUMAN HERPESVIRUS 5 - 30 [hp_X]/59mL ICHTHAMMOL - 12 [hp_X]/59mL INFLUENZA A VIRUS A/VICTORIA/2454/2019 IVR-207 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED) - 30 [hp_X]/59mL JAPANESE ENCEPHALITIS VIRUS STRAIN NAKAYAMA-NIH ANTIGEN (FORMALDEHYDE INACTIVATED) - 30 [hp_X]/59mL MEASLES VIRUS - 30 [hp_X]/59mL SODIUM CHLORIDE - 3 [hp_X]/59mL THUJA OCCIDENTALIS LEAF - 6 [hp_X]/59mL TRIFOLIUM PRATENSE FLOWER - 3 [hp_X]/59mL VACCINIA VIRUS STRAIN NEW YORK CITY BOARD OF HEALTH LIVE ANTIGEN - 30 [hp_X]/59mL |
| 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: | 20 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: | N0000185371 N0000175629 N0000184306 M0000728 M0006342 M0013890 N0000183894 N0000183364 M0357284 M0023305 N0000183917 M0019978 M0569003 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | Y62M9GTW4A 8VJE55B0VG 95OX15I8ZU N20HL7Q941 917J3173FT 4B57CWT710 02I89C6K47 QI7G114Y98 C9642I91WL F5452U54PN Load more... 22G38P19RL 7COI029E6K NQ14646378 2J002Y0B0W 2V2JJ0S00T HT3R7C012Q 451W47IQ8X 0T0DQN8786 4JS0838828 4SV59689SK |
| 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 Food Allergenic Extract [EPC] Inactivated Japanese Encephalitis Virus Vaccine [EPC] Live Vaccinia Virus Vaccine [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] Actively Acquired 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] Milk Proteins [CS] Japanese Encephalitis Vaccines [CS] Vaccines, Inactivated [CS] Smallpox Vaccine [CS] Vaccines, Live, Unattenuated [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: | Actively Acquired Immunity [PE] Allergens [CS] Cell-mediated Immunity [PE] Dietary Proteins [CS] Inactivated Japanese Encephalitis Virus Vaccine [EPC] Increased Histamine Release [PE] Japanese Encephalitis Vaccines [CS] Live Vaccinia Virus Vaccine [EPC] Milk Proteins [CS] Non-Standardized Food Allergenic Extract [EPC] Smallpox Vaccine [CS] Vaccines Inactivated [CS] Live Unattenuated [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 |
|---|---|---|---|---|
| 63083-6017-2 | 59 mL in 1 BOTTLE, DROPPER (63083-6017-2) | 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. | ||||
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