| Drug NDC: | 43742-0577 |
| 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: | Sugar And Food Additive Allergen Mix |
| 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: | Cinnamic Acid, Phloridzinum, Aspartame, Ileum (suis), Jejunum (suis), Stomach (suis), Malvin (chloride), Adenosinum Triphosphoricum Dinatrum, Argentum Nitricum, Fructose, Glucose, Lycopodium Clavatum, Sarcolacticum Acidum, Saccharum Lactis, Saccharum Officinale, Adrenocorticotrophin, High Fructose Corn Syrup, Dysentary Bacillus, Maple Sugar, Morgan Gaertner |
| Also known as the generic name, this is usually the active ingredient(s) of the product. | |
| Labeler Name: | Deseret Biologicals, 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: | ACER SACCHARUM SAP - 30 [hp_C]/mL ADENOSINE TRIPHOSPHATE DISODIUM - 6 [hp_C]/mL ASPARTAME - 6 [hp_X]/mL CINNAMIC ACID - 6 [hp_X]/mL CORTICOTROPIN - 8 [hp_C]/mL DEXTROSE - 6 [hp_C]/mL FRUCTOSE - 6 [hp_C]/mL HIGH FRUCTOSE CORN SYRUP - 9 [hp_C]/mL LACTIC ACID, L- - 6 [hp_C]/mL LACTOSE - 6 [hp_C]/mL Load more... LYCOPODIUM CLAVATUM SPORE - 6 [hp_C]/mL MALVIN - 15 [hp_X]/mL PHLORIZIN - 6 [hp_X]/mL PROTEUS MORGANII - 30 [hp_C]/mL SHIGELLA DYSENTERIAE - 30 [hp_C]/mL SILVER NITRATE - 6 [hp_C]/mL SUCROSE - 6 [hp_C]/mL SUS SCROFA ILEUM - 8 [hp_X]/mL SUS SCROFA JEJUNUM - 8 [hp_X]/mL SUS SCROFA STOMACH - 8 [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: | 06 May, 2015 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 25 Jul, 2024 |
| 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: | 05 May, 2026 |
| This is the date when the listing record will expire if not updated or certified by the firm. | |
| Manufacturer Name: | Deseret Biologicals, 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: | M0000499 N0000175941 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | 75UOH57984 5L51B4DR1G Z0H242BBR1 U14A832J8D K0U68Q2TXA IY9XDZ35W2 6YSS42VSEV XY6UN3QB6S F9S9FFU82N J2B2A4N98G Load more... C88X29Y479 I9I120531L CU9S17279X 56X6LID5ZY 1EP6R5562J 95IT3W8JZE C151H8M554 C998R1XSRA TA501QD69R T0920P9Z9A |
| 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: | Adrenocorticotropic Hormone [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: | Adrenocorticotropic Hormone [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: | Adrenocorticotropic Hormone [CS] Adrenocorticotropic Hormone [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 |
|---|---|---|---|---|
| 43742-0577-1 | 30 mL in 1 BOTTLE, DROPPER (43742-0577-1) | 06 May, 2015 | 25 Jul, 2024 | 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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