| Drug NDC: | 63479-0308 |
| 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: | C08 Calcium Metabolism |
| Also known as the trade name. It is the name of the product chosen by the labeler. | |
| Proprietary Name Base: | C08 |
| The base of the Brand/Proprietary name excluding its suffix. | |
| Proprietary Name Suffix: | CALCIUM METABOLISM |
| 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: | Abies Alba Leafy Twig, Calcarea Acetica, Calcarea Arsenicica, Calcarea Carbonica, Calcarea Fluorica, Calcarea Hypophosphorosa, Calcarea Iodata, Calcarea Muriatica, Calcarea Oxalica, Calcarea Phosphorica, Calcarea Picrata, Calcarea Sulphurica, Calculus Bovis, Calendula Officinalis, Cholesterinum, Hamamelis Virginiana, Hepar Sulphuris Calcareum, Lapis Albus, Silicea, Sulphur Iodatum, Sus Scrofa Parathyroid Gland, Symphytum Officinale, Urtica Urens, Vitamin D |
| 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: | ABIES ALBA LEAFY TWIG - 8 [hp_X]/mL BOS TAURUS GALLSTONE - 15 [hp_X]/mL CALCIUM ACETATE - 12 [hp_X]/mL CALCIUM ARSENATE - 8 [hp_X]/mL CALCIUM CHLORIDE - 12 [hp_X]/mL CALCIUM FLUORIDE - 15 [hp_X]/mL CALCIUM HEXAFLUOROSILICATE - 12 [hp_X]/mL CALCIUM HYPOPHOSPHITE - 12 [hp_X]/mL CALCIUM IODIDE - 12 [hp_X]/mL CALCIUM OXALATE MONOHYDRATE - 12 [hp_X]/mL Load more... CALCIUM PICRATE - 12 [hp_X]/mL CALCIUM SULFATE ANHYDROUS - 12 [hp_X]/mL CALCIUM SULFIDE - 15 [hp_X]/mL CALENDULA OFFICINALIS FLOWERING TOP - 6 [hp_X]/mL CHOLESTEROL - 15 [hp_X]/mL COMFREY ROOT - 6 [hp_X]/mL HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - 6 [hp_X]/mL OYSTER SHELL CALCIUM CARBONATE, CRUDE - 15 [hp_X]/mL SILICON DIOXIDE - 12 [hp_X]/mL SULFUR IODIDE - 12 [hp_X]/mL SUS SCROFA PARATHYROID GLAND - 9 [hp_C]/mL TRIBASIC CALCIUM PHOSPHATE - 15 [hp_X]/mL URTICA URENS - 12 [hp_X]/mL VITAMIN D - 12 [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 Aug, 1988 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 06 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. | |
| UNII: | CE3G3J56LR 4162LZ0N4O Y882YXF34X 95OX15I8ZU M4I0D6VV5M O3B55K4YKI 2NVP93XVQ3 CUI83R2732 8EKI9QEE2H 4PP86KK527 Load more... 53D441QVT8 E934B3V59H 1MBW07J51Q 18E7415PXQ 97C5T2UQ7J M9VVZ08EKQ T7S323PKJS 2E32821G6I ETJ7Z6XBU4 L6L8KA2AA0 2KBE35NE8S 91D9GV0Z28 IHN2NQ5OF9 9VU1KI44GP |
| 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: | Blood Coagulation Factor [EPC] Calcium [CS] Cations Divalent [CS] Increased Coagulation Factor Activity [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 |
|---|---|---|---|---|
| 63479-0308-1 | 30 mL in 1 BOTTLE, GLASS (63479-0308-1) | 15 Aug, 1988 | 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.