Drug NDC: | 63776-244 |
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: | Immunexx |
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: | Bos Taurus Adrenal Gland, Sus Scrofa Adrenal Gland, Ascorbic Acid, Bos Taurus Bone Marrow, Sus Scrofa Bone Marrow, Bos Taurus Red Blood Cell, Sus Scrofa Red Blood Cell, Filgrastim, Aldesleukin, Interferon Gamma-1a, Bos Taurus Lymph, Sus Scrofa Lymph, Bos Taurus Peyers Patches, Sus Scrofa Small Intestine Mucosa Lymph Follicle, Bos Taurus Thymus, Sus Scrofa Thymus |
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: | ALDESLEUKIN - 200 [kp_C]/mL ASCORBIC ACID - 30 [kp_C]/mL BOS TAURUS ADRENAL GLAND - 200 [kp_C]/mL BOS TAURUS BONE MARROW - 30 [kp_C]/mL BOS TAURUS LYMPH - 200 [kp_C]/mL BOS TAURUS PEYER'S PATCH - 200 [kp_C]/mL BOS TAURUS RED BLOOD CELL - 200 [kp_C]/mL BOS TAURUS THYMUS - 200 [kp_C]/mL FILGRASTIM - 200 [kp_C]/mL INTERFERON GAMMA-1A - 200 [kp_C]/mL Load more... SUS SCROFA ADRENAL GLAND - 200 [kp_C]/mL SUS SCROFA BONE MARROW - 30 [kp_C]/mL SUS SCROFA LYMPH - 200 [kp_C]/mL SUS SCROFA PEYER'S PATCH - 200 [kp_C]/mL SUS SCROFA RED BLOOD CELL - 200 [kp_C]/mL SUS SCROFA THYMUS - 200 [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: | 15 Jan, 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: | 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: | N0000178328 N0000009391 M0011506 N0000175667 N0000193618 M0001797 M0024696 M0024695 N0000009451 N0000175666 |
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
UNII: | M89N0Q7EQR PQ6CK8PD0R M2776SWB29 08X0K2M57P UGE0WQC19W XB9AHC8DW1 5W4FLB0U2C 8XEJ88V2T8 PVI5M0M1GW VC9M78242P Load more... 398IYQ16YV VP2CN2G7Y8 33A7VYU29L 308LM01C72 5X23IGF970 7B69B0BD62 |
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: | Lymphocyte Growth Factor [EPC] Vitamin C [EPC] Leukocyte Growth Factor [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 Lymphocyte Activation [PE] Increased Lymphocyte Cell Production [PE] Increased Myeloid Cell 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: | Interleukin-2 [CS] Ascorbic Acid [CS] Granulocyte Colony-Stimulating Factor [CS] Granulocyte-Macrophage Colony-Stimulating Factor [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: | Ascorbic Acid [CS] Granulocyte Colony-Stimulating Factor [CS] Granulocyte-Macrophage Colony-Stimulating Factor [CS] Increased Lymphocyte Activation [PE] Increased Lymphocyte Cell Production [PE] Increased Myeloid Cell Production [PE] Interleukin-2 [CS] Leukocyte Growth Factor [EPC] Lymphocyte Growth Factor [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 |
---|---|---|---|---|
63776-244-14 | 1 BOTTLE, SPRAY in 1 BOX (63776-244-14) / 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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