| Drug NDC: | 63479-0304 |
| 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: | C04 Arthro Muscotox |
| Also known as the trade name. It is the name of the product chosen by the labeler. | |
| Proprietary Name Base: | C04 |
| The base of the Brand/Proprietary name excluding its suffix. | |
| Proprietary Name Suffix: | ARTHRO MUSCOTOX |
| 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: | Actaea Spicata, Ammonium Benzoicum, Arnica Montana, Bellis Perennis, Berberis Vulgaris, Bryonia, Chelidonium Majus, Chininum Sulphuricum, Dulcamara Lignosa Whole, Echinacea Purpurea, Formica Rufa, Fraxinus Excelsior Leaf, Lacticum Acidum, Ledum Palustre, Pulsatilla Vulgaris, Rhododendron Chrysanthum, Rhus Toxicodendron, Ruta Graveolens, Sarcolacticum Acidum, Symphytum Officinale, Uricum Acidum |
| Also known as the generic name, this is usually the active ingredient(s) of the product. | |
| Labeler Name: | Apex Energetics Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. | |
| Dosage Form: | Solution/ Drops |
| 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: | ACTAEA SPICATA ROOT - 12 [hp_X]/mL AMMONIUM BENZOATE - 9 [hp_X]/mL ARNICA MONTANA - 30 [hp_X]/mL BELLIS PERENNIS - 12 [hp_X]/mL BERBERIS VULGARIS ROOT BARK - 1 [hp_X]/mL BRYONIA ALBA ROOT - 30 [hp_X]/mL CHELIDONIUM MAJUS - 1 [hp_X]/mL COMFREY ROOT - 9 [hp_X]/mL ECHINACEA PURPUREA - 1 [hp_X]/mL FORMICA RUFA - 30 [hp_X]/mL Load more... FRAXINUS EXCELSIOR LEAF - 1 [hp_X]/mL LACTIC ACID, DL- - 30 [hp_X]/mL LACTIC ACID, L- - 15 [hp_X]/mL PULSATILLA VULGARIS WHOLE - 30 [hp_X]/mL QUININE SULFATE - 9 [hp_X]/mL RHODODENDRON AUREUM LEAF - 12 [hp_X]/mL RHODODENDRON TOMENTOSUM LEAFY TWIG - 6 [hp_X]/mL RUTA GRAVEOLENS FLOWERING TOP - 9 [hp_X]/mL SOLANUM DULCAMARA WHOLE - 30 [hp_X]/mL TOXICODENDRON PUBESCENS LEAF - 30 [hp_X]/mL URIC ACID - 15 [hp_X]/mL |
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. | |
| Route Details: | SUBLINGUAL |
| 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 Dec, 1994 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 09 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: | Apex Energetics 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. | |
| UPC: | 0818960011703 |
| UPC stands for Universal Product Code. | |
| UNII: | 3FU86L9OS0 AC80WD7GPF O80TY208ZW 2HU33I03UY 1TH8Q20J0U T7J046YI2B 7E889U5RNN M9VVZ08EKQ QI7G114Y98 55H0W83JO5 Load more... RC38362Q7M 3B8D35Y7S4 F9S9FFU82N I76KB35JEV KF7Z0E0Q2B IV92NQJ73U 877L01IZ0P N94C2U587S G72JA9DHK5 6IO182RP7A 268B43MJ25 |
| 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: | Antimalarial [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 |
|---|---|---|---|---|
| 63479-0304-1 | 30 mL in 1 BOTTLE, GLASS (63479-0304-1) | 15 Dec, 1994 | 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.