| Drug NDC: | 44911-0665 |
| 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: | Metabatone |
| 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: | Aralia Racemosa, Avena Sativa, Berberis Vulgaris, Capsicum Annuum, Ginkgo Biloba, Phytolacca Decandra, Hypothalamus Suis, Adenosinum Triphosphoricum Dinatrum, Alpha-ketoglutaricum Acidum, Fel Tauri, Hyaluronidase, Pancreas Suis, Pancreatinum, Papain, Stomach (suis), L-alanine, L- Arginine, L-carnitine, Cysteinum, L-glutamine, L-histidine, L-isoleucine, L-leucine, L-lysine, L-methionine, L-ornithine, L-proline, L-serine, L-tryptophan, L-tyrosine, L-valine, Calcarea Carbonica, Calcarea Phosphorica, Iodium, |
| Also known as the generic name, this is usually the active ingredient(s) of the product. | |
| Labeler Name: | Energique, 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: | ADENOSINE TRIPHOSPHATE DISODIUM - 9 [hp_X]/mL ALANINE - 12 [hp_X]/mL ARALIA RACEMOSA ROOT - 3 [hp_X]/mL ARGININE - 12 [hp_X]/mL AVENA SATIVA FLOWERING TOP - 3 [hp_X]/mL BERBERIS VULGARIS ROOT BARK - 3 [hp_X]/mL BOS TAURUS BILE - 9 [hp_X]/mL BROMELAINS - 9 [hp_C]/mL CALCIUM SULFIDE - 12 [hp_X]/mL CAPSICUM - 3 [hp_X]/mL Load more... CYSTEINE - 12 [hp_X]/mL GINKGO - 3 [hp_X]/mL GLUTAMINE - 12 [hp_X]/mL GRAPHITE - 12 [hp_X]/mL HISTIDINE - 12 [hp_X]/mL HYALURONIDASE (BOVINE) - 9 [hp_X]/mL IODINE - 12 [hp_X]/mL ISOLEUCINE - 12 [hp_X]/mL LEUCINE - 12 [hp_X]/mL LEVOCARNITINE - 12 [hp_X]/mL LYCOPODIUM CLAVATUM SPORE - 12 [hp_X]/mL LYSINE - 12 [hp_X]/mL MAGNESIUM CARBONATE - 12 [hp_X]/mL METHIONINE - 12 [hp_X]/mL ORNITHINE - 12 [hp_X]/mL OXOGLURIC ACID - 9 [hp_X]/mL OYSTER SHELL CALCIUM CARBONATE, CRUDE - 12 [hp_X]/mL PANCRELIPASE - 9 [hp_X]/mL PAPAIN - 9 [hp_X]/mL PHYTOLACCA AMERICANA ROOT - 5 [hp_X]/mL PROLINE - 12 [hp_X]/mL SERINE - 12 [hp_X]/mL SODIUM CHLORIDE - 12 [hp_X]/mL SUS SCROFA PANCREAS - 9 [hp_X]/mL SUS SCROFA PITUITARY GLAND - 9 [hp_X]/mL SUS SCROFA STOMACH - 9 [hp_X]/mL TRIBASIC CALCIUM PHOSPHATE - 12 [hp_X]/mL TRYPTOPHAN - 12 [hp_X]/mL TYROSINE - 12 [hp_X]/mL VALINE - 12 [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: | 28 Dec, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 07 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, 2024 |
| This is the date when the listing record will expire if not updated or certified by the firm. | |
| Manufacturer Name: | Energique, 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: | N0000175780 M0000922 N0000185375 N0000185371 N0000175629 N0000184306 M0000728 M0006342 M0016962 M0022575 M0003493 N0000175903 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | 5L51B4DR1G OF5P57N2ZX T90W4582DU 94ZLA3W45F MA9CQJ3F7F 1TH8Q20J0U ET3651ZLOU U182GP2CF3 1MBW07J51Q 00UK7646FG Load more... K848JZ4886 19FUJ2C58T 0RH81L854J 4QQN74LH4O 4QD397987E 8KOG53Z5EM 9679TC07X4 04Y7590D77 GMW67QNF9C 0G389FZZ9M C88X29Y479 K3Z4F929H6 0E53J927NA AE28F7PNPL E524N2IXA3 8ID597Z82X 2E32821G6I FQ3DRG0N5K A236A06Y32 11E6VI8VEG 9DLQ4CIU6V 452VLY9402 451W47IQ8X 9Y3J3362RY L0PFEMQ1DT T0920P9Z9A 91D9GV0Z28 8DUH1N11BX 42HK56048U HG18B9YRS7 |
| 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: | Amino Acid [EPC] Non-Standardized Plant Allergenic Extract [EPC] Non-Standardized Food Allergenic Extract [EPC] Carnitine Analog [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] |
| 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: | Amino Acids [CS] Allergens [CS] Dietary Proteins [CS] Plant Proteins [CS] Vegetable Proteins [CS] Carnitine [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: | Allergens [CS] Amino Acid [EPC] Amino Acids [CS] Blood Coagulation Factor [EPC] Calcium [CS] Carnitine Analog [EPC] Carnitine [CS] Cations Divalent [CS] Cell-mediated Immunity [PE] Dietary Proteins [CS] Endoglycosidase [EPC] Glycoside Hydrolases [CS] Increased Coagulation Factor Activity [PE] Increased Histamine Release [PE] Non-Standardized Food Allergenic Extract [EPC] Non-Standardized Plant Allergenic Extract [EPC] Plant Proteins [CS] Vegetable Proteins [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 |
|---|---|---|---|---|
| 44911-0665-1 | 30 mL in 1 BOTTLE, DROPPER (44911-0665-1) | 28 Dec, 2022 | 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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