| Drug NDC: | 63479-0111 |
| 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: | A11 Enviro-protect |
| Also known as the trade name. It is the name of the product chosen by the labeler. | |
| Proprietary Name Base: | A11 |
| The base of the Brand/Proprietary name excluding its suffix. | |
| Proprietary Name Suffix: | ENVIRO-PROTECT |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. | |
| 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: | Allium Sativum, Alternaria Alternata, Ascorbicum Acidum, Aspergillus Niger, Aureobasidium Pullulans, Berberis Vulgaris, Cadmium Metallicum, Carboneum Oxygenisatum, Chelidonium Majus, Chlorinum, Cladosporium Phaerospermum, Cochliobolus Sativus, Cochliobolus Spicifer, Gibberella Fujikuroi, House Dust, Lead, Lycopodium Clavatum, Malus Sylvestris, Mucor Plumbeus, Niacin, Penicillium Notatum, Petrolatum, Phenol, Quercus Robur, Rhizopus Stolonifer, Solidago Virgaurea, Tabacum, Vitamin A, Vitamin E |
| Also known as the generic name, this is usually the active ingredient(s) of the product. | |
| Labeler Name: | Apex Energetics Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. | |
| Dosage Form: | Solution/ Drops |
| 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 ACETATE - 15 [hp_X]/mL ALTERNARIA ALTERNATA - 30 [hp_X]/mL ASCORBIC ACID - 12 [hp_X]/mL ASPERGILLUS NIGER VAR. NIGER - 30 [hp_X]/mL AUREOBASIDIUM PULLULANS VAR. PULLUTANS - 30 [hp_X]/mL BERBERIS VULGARIS ROOT BARK - 10 [hp_X]/mL CADMIUM - 15 [hp_X]/mL CARBON MONOXIDE - 30 [hp_X]/mL CHELIDONIUM MAJUS - 8 [hp_X]/mL CHLORINE - 30 [hp_X]/mL Load more... CLADOSPORIUM SPHAEROSPERMUM - 30 [hp_X]/mL COCHLIOBOLUS SATIVUS - 30 [hp_X]/mL COCHLIOBOLUS SPICIFER - 30 [hp_X]/mL GARLIC - 10 [hp_X]/mL GIBBERELLA FUJIKUROI - 30 [hp_X]/mL HOUSE DUST - 100 [hp_X]/mL LEAD - 30 [hp_X]/mL LYCOPODIUM CLAVATUM SPORE - 12 [hp_X]/mL MALUS SYLVESTRIS FLOWER - 15 [hp_X]/mL MINERAL OIL - 30 [hp_X]/mL MUCOR PLUMBEUS - 30 [hp_X]/mL NIACIN - 12 [hp_X]/mL PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM - 30 [hp_X]/mL PHENOL - 30 [hp_X]/mL QUERCUS ROBUR FLOWER BUD - 9 [hp_X]/mL RHIZOPUS STOLONIFER - 30 [hp_X]/mL SOLIDAGO VIRGAUREA FLOWERING TOP - 9 [hp_X]/mL TOBACCO LEAF - 15 [hp_X]/mL VITAMIN A ACETATE - 12 [hp_X]/mL |
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. | |
| Route Details: | SUBLINGUAL |
| 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 Aug, 1988 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 24 Dec, 2025 |
| 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: | Apex Energetics 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. | |
| UPC: | 0818960011192 |
| UPC stands for Universal Product Code. | |
| NUI: | N0000185372 N0000175629 N0000184306 N0000185001 M0008890 M0000728 N0000193618 M0001797 N0000185371 M0006342 M0016962 N0000185374 M0006896 N0000175594 M0014839 N0000185375 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | 9E8X80D2L0 52B29REC7H PQ6CK8PD0R 9IOA40ANG6 D1A2NG69CK 1TH8Q20J0U 00BH33GNGH 7U1EE4V452 7E889U5RNN 4R7X1O2820 Load more... P87YCA1U8R 3LN5B70U4W 91M9RWP3TD V1V998DC17 815V716OR2 EYO007VX98 2P299V784P C88X29Y479 6ZJ8N1924Z T5L8T28FGP D7401PWY6E 2679MF687A 3Y1PE1GCIG 339NCG44TV VC5I578BE3 FEE198DK4Q 5405K23S50 6YR2608RSU 3LE3D9D6OY |
| 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: | Non-Standardized Fungal Allergenic Extract [EPC] Vitamin C [EPC] Non-Standardized Food Allergenic Extract [EPC] Non-Standardized House Dust Allergenic Extract [EPC] Nicotinic Acid [EPC] Non-Standardized Plant Allergenic Extract [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] Increased IgG Production [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: | Fungal Proteins [CS] Allergens [CS] Ascorbic Acid [CS] Dietary Proteins [CS] Plant Proteins [CS] House Dust [CS] Nicotinic Acids [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] Ascorbic Acid [CS] Cell-mediated Immunity [PE] Dietary Proteins [CS] Fungal Proteins [CS] House Dust [CS] Increased Histamine Release [PE] Increased IgG Production [PE] Nicotinic Acid [EPC] Nicotinic Acids [CS] Non-Standardized Food Allergenic Extract [EPC] Non-Standardized Fungal Allergenic Extract [EPC] Non-Standardized House Dust Allergenic Extract [EPC] Non-Standardized Plant Allergenic Extract [EPC] Plant Proteins [CS] Vitamin A [CS] Vitamin A [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 |
|---|---|---|---|---|
| 63479-0111-1 | 30 mL in 1 BOTTLE, GLASS (63479-0111-1) | 15 Aug, 1988 | 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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