| Drug NDC: | 63479-0101 |
| 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: | A01 Cellular Recharge |
| Also known as the trade name. It is the name of the product chosen by the labeler. | |
| Proprietary Name Base: | A01 |
| The base of the Brand/Proprietary name excluding its suffix. | |
| Proprietary Name Suffix: | CELLULAR RECHARGE |
| 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: | Aceticum Acidum, Arnica Montana, Avena Sativa, Calcarea Carbonica, Calcarea Phosphorica, Calcarea Sulphurica, Ceanothus Americanus, Ceratostigma Illmottianum, Chininum Arsenicosum, Citricum Acidum, English Elm, European Hornbeam, European Olive, Gentianella Amarella, Hydrofluoricum Acidum, Juglans Regia, Lacticum Acidum, Magnesia Phosphorica, Natrum Muriaticum, Natrum Phosphoricum, Natrum Silicofluoricum, Natrum Sulphuricum, Passiflora Incarnata, Phosphoricum Acidum, Sarcolacticum Acidum, Solidago Virgaurea |
| 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: | ACETIC ACID - 30 [hp_X]/mL ANHYDROUS CITRIC ACID - 30 [hp_X]/mL ARNICA MONTANA - 12 [hp_C]/mL AVENA SATIVA FLOWERING TOP - 1 [hp_X]/mL CALCIUM SULFATE ANHYDROUS - 12 [hp_X]/mL CARPINUS BETULUS FLOWER - 9 [hp_X]/mL CEANOTHUS AMERICANUS LEAF - 4 [hp_X]/mL CERATOSTIGMA WILLMOTTIANUM FLOWER - 12 [hp_X]/mL GENTIANELLA AMARELLA FLOWER - 12 [hp_X]/mL HYDROFLUORIC ACID - 30 [hp_X]/mL Load more... JUGLANS REGIA FLOWERING TOP - 9 [hp_X]/mL LACTIC ACID, DL- - 15 [hp_X]/mL LACTIC ACID, L- - 15 [hp_X]/mL MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE - 15 [hp_X]/mL OLEA EUROPAEA FLOWER - 12 [hp_X]/mL OYSTER SHELL CALCIUM CARBONATE, CRUDE - 15 [hp_X]/mL PASSIFLORA INCARNATA FLOWERING TOP - 1 [hp_X]/mL PHOSPHORIC ACID - 30 [hp_X]/mL QUININE ARSENITE - 15 [hp_X]/mL SODIUM CHLORIDE - 30 [hp_X]/mL SODIUM HEXAFLUOROSILICATE - 8 [hp_X]/mL SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE - 12 [hp_X]/mL SODIUM SULFATE - 10 [hp_X]/mL SOLIDAGO VIRGAUREA FLOWERING TOP - 1 [hp_X]/mL TRIBASIC CALCIUM PHOSPHATE - 15 [hp_X]/mL ULMUS PROCERA FLOWERING TWIG - 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 Dec, 1994 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 18 Jun, 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: | 0818960011109 |
| UPC stands for Universal Product Code. | |
| NUI: | N0000175833 N0000175835 N0000175980 N0000008556 N0000175089 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | Q40Q9N063P XF417D3PSL O80TY208ZW MA9CQJ3F7F E934B3V59H 07YL55QKZ9 25B1Y14T8N TP69J995TW ZKH2SOY1AR RGL5YE86CZ Load more... 3BA2N709NG 3B8D35Y7S4 F9S9FFU82N HF539G9L3Q 498M34P1VZ 2E32821G6I CLF5YFS11O E4GA8884NN 42QO5P0NLM 451W47IQ8X 806AV2E065 70WT22SF4B 0YPR65R21J 5405K23S50 91D9GV0Z28 J3O020I532 |
| 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 MOA: | Acidifying Activity [MoA] Calcium Chelating Activity [MoA] |
| Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`. | |
| Pharmacologic Class EPC: | Calculi Dissolution Agent [EPC] Anti-coagulant [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: | Decreased Coagulation Factor Activity [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: | Acidifying Activity [MoA] Anti-coagulant [EPC] Antimalarial [EPC] Blood Coagulation Factor [EPC] Calcium Chelating Activity [MoA] Calcium [CS] Calculi Dissolution Agent [EPC] Cations Divalent [CS] Decreased Coagulation Factor Activity [PE] Increased Coagulation Factor Activity [PE] Increased Large Intestinal Motility [PE] Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] Inhibition Small Intestine Fluid/Electrolyte Absorption [PE] Magnesium Ion Exchange Activity [MoA] Osmotic Activity [MoA] Osmotic Laxative [EPC] Stimulation Large Intestine Fluid/Electrolyte Secretion [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 |
|---|---|---|---|---|
| 63479-0101-1 | 30 mL in 1 BOTTLE, GLASS (63479-0101-1) | 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. | ||||
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