| Drug NDC: | 43853-0043 |
| 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: | Immune Support |
| 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: | Arsenicum Album, Rumex, Squilla Maritima, Bryonia Alba, Kali Carbonicum, Glutathione, Vitamin C, Vitamin C, Zinc Picolinate, Vitamin B, Vitamin E, Beta Glucan, Curcumin, Grapefruit Seed, Oregano Leaf, Garlic Bulb, Olive Leaf, Apple Cider Vinegar, Astragalus Root, Maitake Mushroom, Cats Claw Bark |
| Also known as the generic name, this is usually the active ingredient(s) of the product. | |
| Labeler Name: | Problen |
| 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: | .ALPHA.-TOCOPHEROL - 30 [hp_X]/30mL APPLE CIDER VINEGAR - 30 [hp_X]/30mL ARSENIC TRIOXIDE - 30 [hp_X]/30mL ASCORBIC ACID - 30 [hp_X]/30mL ASCORBYL PALMITATE - 30 [hp_X]/30mL ASTRAGALUS PROPINQUUS ROOT - 30 [hp_X]/30mL BIANCAEA DECAPETALA ROOT BARK - 30 [hp_X]/30mL BRYONIA ALBA ROOT - 30 [hp_X]/30mL CITRUS PARADISI SEED - 30 [hp_X]/30mL CURCUMIN - 30 [hp_X]/30mL Load more... CURDLAN - 30 [hp_X]/30mL DRIMIA MARITIMA BULB - 30 [hp_X]/30mL GARLIC - 30 [hp_X]/30mL GLUTATHIONE - 30 [hp_X]/30mL MAITAKE - 30 [hp_X]/30mL OLEA EUROPAEA LEAF - 30 [hp_X]/30mL OREGANO - 30 [hp_X]/30mL POTASSIUM CARBONATE - 30 [hp_X]/30mL PYRIDOXINE - 30 [hp_X]/30mL RUMEX CRISPUS ROOT - 30 [hp_X]/30mL ZINC PICOLINATE - 30 [hp_X]/30mL |
| 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: | 15 Apr, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 15 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: | ProBLEN |
| 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 N0000185371 N0000175629 N0000184306 M0000728 M0006342 M0016962 M0008672 N0000192800 N0000005657 N0000175452 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | H4N855PNZ1 0UE22Q87VC S7V92P67HO PQ6CK8PD0R QN83US2B0N 922OP8YUPF ZU9WPR8MU2 T7J046YI2B 12F08874Y7 IT942ZTH98 Load more... 6930DL209R 3629601H5D V1V998DC17 GAN16C9B8O A1U5YJI0Z8 MJ95C3OH47 0E5AT8T16U BQN1B9B9HA KV2JZ1BI6Z 9N1RM2S62C ALO92O31SE |
| 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: | Vitamin C [EPC] Non-Standardized Food Allergenic Extract [EPC] Vitamin B6 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: | Ascorbic Acid [CS] Allergens [CS] Dietary Proteins [CS] Plant Proteins [CS] Food Additives [CS] Vitamin B 6 [Chemical/Ingredient] Analogs/Derivatives [Chemical/Ingredient] |
| 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] Analogs/Derivatives [Chemical/Ingredient] Ascorbic Acid [CS] Cell-mediated Immunity [PE] Copper Absorption Inhibitor [EPC] Decreased Copper Ion Absorption [PE] Dietary Proteins [CS] Food Additives [CS] Increased Histamine Release [PE] Non-Standardized Food Allergenic Extract [EPC] Plant Proteins [CS] 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 |
|---|---|---|---|---|
| 43853-0043-1 | 30 mL in 1 BOTTLE (43853-0043-1) | 15 Apr, 2021 | 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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