| Drug NDC: | 70321-0003 |
| 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: | Energize |
| Also known as the trade name. It is the name of the product chosen by the labeler. | |
| 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: | Colchicum Autumnale, Conium Maculatum, Hydrastis Canadensis, Vaccinium Myrtillus, Podophyllum Peltatum, Ascorbic Acid, Galium Aparine, Nicotinamidum, Pyridoxinum Hydrochloricum, Riboflavinum, Sarcolacticum Acidum, Thiaminum Hydrochloricum, Norepinephrine, Alpha-lipoicum Acidum, Natrum Oxalaceticum, Sulphur, Acetylsalicylicum Acidum, Adenosinum Triphosphoricum Dinatrum, Anthrachinonum, Histaminum Hydrochloricum, Magnesium Gluconicum Dihydricum, Nadidum, Naphthochinonum, Pantothenic Acid |
| Also known as the generic name, this is usually the active ingredient(s) of the product. | |
| Labeler Name: | Parasitology Center Inc. |
| 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: | 1,4-NAPHTHOQUINONE - 10 [hp_X]/mL ADENOSINE TRIPHOSPHATE DISODIUM - 10 [hp_X]/mL ASCORBIC ACID - 6 [hp_X]/mL ASPIRIN - 10 [hp_X]/mL BACILLUS ANTHRACIS IMMUNOSERUM RABBIT - 10 [hp_X]/mL BILBERRY - 4 [hp_X]/mL COLCHICUM AUTUMNALE BULB - 4 [hp_X]/mL CONIUM MACULATUM FLOWERING TOP - 4 [hp_X]/mL GALIUM APARINE - 6 [hp_X]/mL GOLDENSEAL - 4 [hp_X]/mL Load more... HISTAMINE DIHYDROCHLORIDE - 10 [hp_X]/mL HYDROQUININE - 3 [hp_C]/mL LACTIC ACID, L- - 6 [hp_X]/mL MAGNESIUM GLUCONATE - 10 [hp_X]/mL MANGANESE PHOSPHATE, DIBASIC - 15 [hp_X]/mL NADIDE - 10 [hp_X]/mL NIACINAMIDE - 6 [hp_X]/mL NOREPINEPHRINE - 6 [hp_X]/mL PANTOTHENIC ACID - 10 [hp_X]/mL PODOPHYLLUM - 5 [hp_X]/mL PYRIDOXINE HYDROCHLORIDE - 6 [hp_X]/mL RIBOFLAVIN - 6 [hp_X]/mL SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS - 30 [hp_C]/mL SODIUM DIETHYL OXALACETATE - 8 [hp_X]/mL SULFUR - 8 [hp_X]/mL THIAMINE HYDROCHLORIDE - 6 [hp_X]/mL THIOCTIC ACID - 8 [hp_X]/mL UBIDECARENONE - 10 [hp_X]/mL |
| 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: | 27 Apr, 2016 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 10 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: | Parasitology Center 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. | |
| NUI: | N0000193618 M0001797 N0000000160 N0000008836 M0001335 N0000175722 N0000175578 N0000008832 N0000175570 M0003647 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | RBF5ZU7R7K 5L51B4DR1G PQ6CK8PD0R R16CO5Y76E 41LZ22DD4N 9P2U39H18W 993QHL78E6 Q28R5GF371 Z4B6561488 ZW3Z11D0JV Load more... 3POA0Q644U 31J3Q51T6L F9S9FFU82N T42NAD2KHC VZ3U1H7Q5B 0U46U6E8UK 25X51I8RD4 X4W3ENH1CV 19F5HK2737 2S713A4VP3 68Y4CF58BV TLM2976OFR Y3V16D4PV4 6CA025Y4FG 70FD1KFU70 M572600E5P 73Y7P0K73Y EJ27X76M46 |
| 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: | Cyclooxygenase Inhibitors [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: | Vitamin C [EPC] Nonsteroidal Anti-inflammatory Drug [EPC] Platelet Aggregation Inhibitor [EPC] Catecholamine [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 Prostaglandin Production [PE] Decreased Platelet Aggregation [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] Anti-Inflammatory Agents, Non-Steroidal [CS] Catecholamines [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: | Analogs/Derivatives [Chemical/Ingredient] Anti-Inflammatory Agents Non-Steroidal [CS] Ascorbic Acid [CS] Calculi Dissolution Agent [EPC] Catecholamine [EPC] Catecholamines [CS] Cyclooxygenase Inhibitors [MoA] Decreased Platelet Aggregation [PE] Decreased Prostaglandin Production [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] Magnetic Resonance Contrast Activity [MoA] Nonsteroidal Anti-inflammatory Drug [EPC] Osmotic Activity [MoA] Osmotic Laxative [EPC] Paramagnetic Contrast Agent [EPC] Platelet Aggregation Inhibitor [EPC] Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] Vitamin B 6 [Chemical/Ingredient] Vitamin B6 Analog [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 |
|---|---|---|---|---|
| 70321-0003-1 | 30 mL in 1 BOTTLE, DROPPER (70321-0003-1) | 27 Apr, 2016 | 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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