| Drug NDC: | 49304-0012 |
| 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: | Thyroid Rhythm |
| 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: | Adrenalinum, Calarea Carbonica, Calcarea Fluorica, Calcarea Iodata, Ferrum Iodatum, Fucus Vesiculosus, Iodium, Kali Iodatum, Naturm Muriaticum |
| Also known as the generic name, this is usually the active ingredient(s) of the product. | |
| Labeler Name: | Alternative Pharmacy |
| 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: | BOS TAURUS PITUITARY GLAND - 6 [hp_X]/mL BOS TAURUS SPLEEN - 6 [hp_X]/mL BOS TAURUS THYMUS - 6 [hp_X]/mL CALCIUM FLUORIDE - 8 [hp_X]/mL CALCIUM IODIDE - 6 [hp_X]/mL EPINEPHRINE - 6 [hp_X]/mL FERROUS IODIDE - 8 [hp_X]/mL FUCUS VESICULOSUS - 6 [hp_X]/mL IODINE - 9 [hp_X]/mL OYSTER SHELL CALCIUM CARBONATE, CRUDE - 30 [hp_X]/mL Load more... POTASSIUM IODIDE - 6 [hp_X]/mL SODIUM CHLORIDE - 30 [hp_X]/mL SPONGIA OFFICINALIS SKELETON, ROASTED - 6 [hp_X]/mL SUS SCROFA THYROID - 6 [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: | 03 Oct, 2013 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 31 Mar, 2023 |
| 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: | 12 Jun, 2026 |
| This is the date when the listing record will expire if not updated or certified by the firm. | |
| Manufacturer Name: | Alternative Pharmacy |
| 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: | N0000000209 N0000000245 N0000175552 N0000175555 N0000175570 M0003647 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | 7JM57I419K 190Q9MB3U3 8XEJ88V2T8 O3B55K4YKI 8EKI9QEE2H YKH834O4BH F5452U54PN 535G2ABX9M 9679TC07X4 2E32821G6I Load more... 1C4QK22F9J 451W47IQ8X 1PIP394IID 6RV024OAUQ |
| 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: | Adrenergic alpha-Agonists [MoA] Adrenergic beta-Agonists [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: | alpha-Adrenergic Agonist [EPC] beta-Adrenergic Agonist [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 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: | Adrenergic alpha-Agonists [MoA] Adrenergic beta-Agonists [MoA] Blood Coagulation Factor [EPC] Calcium [CS] Catecholamine [EPC] Catecholamines [CS] Cations Divalent [CS] Increased Coagulation Factor Activity [PE] alpha-Adrenergic Agonist [EPC] beta-Adrenergic Agonist [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 |
|---|---|---|---|---|
| 49304-0012-1 | 30 mL in 1 BOTTLE, DROPPER (49304-0012-1) | 03 Oct, 2013 | 31 Mar, 2023 | 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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