| Drug NDC: | 63776-250 |
| 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: | Intra-cell |
| 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: | Ingredients |
| Also known as the generic name, this is usually the active ingredient(s) of the product. | |
| Labeler Name: | Viatrexx Bio Incorporated |
| Name of Company corresponding to the labeler code segment of the ProductNDC. | |
| Dosage Form: | Spray |
| 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.-LIPOIC ACID - 30 [kp_C]/mL .ALPHA.-TOCOPHEROL - 30 [kp_C]/mL ACETYLCARNITINE - 30 [kp_C]/mL ADENOSINE TRIPHOSPHATE - 30 [kp_C]/mL ASCORBIC ACID - 30 [kp_C]/mL CALCIUM GLUCONATE - 30 [kp_C]/mL CITRIC ACID MONOHYDRATE - 30 [kp_C]/mL COLCHICUM AUTUMNALE BULB - 200 [kp_C]/mL CONIUM MACULATUM FLOWERING TOP - 30 [kp_C]/mL CUPRIC SULFATE - 30 [kp_C]/mL Load more... CYANOCOBALAMIN - 30 [kp_C]/mL FERRIC CHLORIDE HEXAHYDRATE - 30 [kp_C]/mL FOLIC ACID - 30 [kp_C]/mL FUMARIC ACID - 30 [kp_C]/mL LACTIC ACID - 30 [kp_C]/mL MAGNESIUM PHOSPHATE, TRIBASIC, PENTAHYDRATE - 30 [kp_C]/mL MANGANESE GLUCONATE - 30 [kp_C]/mL MANGANESE PHOSPHATE, DIBASIC - 30 [kp_C]/mL MERCURIUS SOLUBILIS - 30 [kp_C]/mL NIACIN - 30 [kp_C]/mL PANTOTHENIC ACID - 30 [kp_C]/mL PHOSPHORUS - 30 [kp_C]/mL PODOPHYLLUM - 30 [kp_C]/mL POTASSIUM ASPARTATE - 30 [kp_C]/mL PYRIDOXINE - 30 [kp_C]/mL PYRUVALDEHYDE - 30 [kp_C]/mL QUINHYDRONE - 30 [kp_C]/mL RIBOFLAVIN - 30 [kp_C]/mL SACCHAROMYCES CEREVISIAE RNA - 30 [kp_C]/mL SELENOMETHIONINE - 30 [kp_C]/mL SODIUM DIETHYL OXALACETATE - 30 [kp_C]/mL SODIUM PYRUVATE - 30 [kp_C]/mL SUCCINIC ACID - 30 [kp_C]/mL SULFUR - 30 [kp_C]/mL THIAMINE - 30 [kp_C]/mL UBIDECARENONE - 30 [kp_C]/mL ZINC GLUCONATE - 30 [kp_C]/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: | 24 Jul, 2012 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 06 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: | VIATREXX BIO INCORPORATED |
| 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 M0022794 N0000175951 N0000175594 M0014839 N0000192800 N0000005657 N0000175452 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | 73Y7P0K73Y H4N855PNZ1 6DH1W9VH8Q 8L70Q75FXE PQ6CK8PD0R SQE6VB453K 2968PHW8QP 993QHL78E6 Q28R5GF371 LRX7AJ16DT Load more... P6YC3EG204 0I2XIN602U 935E97BOY8 88XHZ13131 33X04XA5AT 453COF7817 9YY2F980SV VZ3U1H7Q5B 324Y4038G2 2679MF687A 19F5HK2737 27YLU75U4W 2S713A4VP3 OC4598NZEQ KV2JZ1BI6Z 722KLD7415 P4A66LQ3QJ TLM2976OFR J17GBZ5VGX 964MRK2PEL 6CA025Y4FG POD38AIF08 AB6MNQ6J6L 70FD1KFU70 X66NSO3N35 EJ27X76M46 U6WSN5SQ1Z |
| 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] Vitamin B12 [EPC] Nicotinic Acid [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 CS: | Ascorbic Acid [CS] Vitamin B 12 [CS] Nicotinic Acids [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: | Acidifying Activity [MoA] Analogs/Derivatives [Chemical/Ingredient] Anti-coagulant [EPC] Ascorbic Acid [CS] Blood Coagulation Factor [EPC] Calcium Chelating Activity [MoA] Calcium [CS] Calculi Dissolution Agent [EPC] Carnitine Analog [EPC] Carnitine [CS] Cations Divalent [CS] Copper Absorption Inhibitor [EPC] Decreased Coagulation Factor Activity [PE] Decreased Copper Ion Absorption [PE] Depigmenting Activity [PE] Increased Coagulation Factor Activity [PE] Increased Large Intestinal Motility [PE] Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] Inhibition Small Intestine Fluid/Electrolyte Absorption [PE] Iron [CS] Magnesium Ion Exchange Activity [MoA] Magnetic Resonance Contrast Activity [MoA] Melanin Synthesis Inhibitor [EPC] Melanin Synthesis Inhibitors [MoA] Nicotinic Acid [EPC] Nicotinic Acids [CS] Osmotic Activity [MoA] Osmotic Laxative [EPC] Paramagnetic Contrast Agent [EPC] Parenteral Iron Replacement [EPC] Phosphate Binder [EPC] Phosphate Chelating Activity [MoA] Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] Vitamin B 12 [CS] Vitamin B 6 [Chemical/Ingredient] Vitamin B12 [EPC] 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 |
|---|---|---|---|---|
| 63776-250-14 | 1 BOTTLE, SPRAY in 1 BOX (63776-250-14) / 30 mL in 1 BOTTLE, SPRAY | 24 Jul, 2012 | 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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