NDC 57962-007 Imbruvica
Ibrutinib Suspension Oral - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
- 57962 - Pharmacyclics Llc
- 57962-007 - Imbruvica
Product Packages
NDC Code 57962-007-12
Package Description: 1 BOTTLE, GLASS in 1 CARTON / 108 mL in 1 BOTTLE, GLASS
Product Details
What is NDC 57962-007?
What are the uses for Imbruvica?
What are Imbruvica Active Ingredients?
What is the NDC to RxNorm Crosswalk for Imbruvica?
- RxCUI: 1442986 - ibrutinib 140 MG Oral Capsule
- RxCUI: 1442992 - Imbruvica 140 MG Oral Capsule
- RxCUI: 1442992 - ibrutinib 140 MG Oral Capsule [Imbruvica]
- RxCUI: 1994360 - ibrutinib 70 MG Oral Capsule
- RxCUI: 1994362 - Imbruvica 70 MG Oral Capsule
Which are the Pharmacologic Classes for Imbruvica?
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Patient Education
Ibrutinib
Ibrutinib is used: to treat people with mantle cell lymphoma (MCL; a fast-growing cancer that begins in the cells of the immune system) who have already been treated with at least one other chemotherapy medication, to treat people with chronic lymphocytic leukemia (CLL; a type of cancer that begins in the white blood cells) and small lymphocytic lymphoma (SLL; a type of cancer that begins mostly in the lymph nodes), to treat people with Waldenstrom's macroglobulinemia (WM; a slow-growing cancer that begins in certain white blood cells in your bone marrow), to treat people with marginal zone lymphoma (MZL; a slow growing cancer that begins in a type of white blood cells that normally fights infection) who have already been treated with a certain type of chemotherapy medication, and to treat people with chronic graft vs host disease (cGVHD; a complication of hematopoietic stem-cell transplant [HSCT; a procedure that replaces diseased bone marrow with healthy bone marrow] that may start a while after the transplant and last for a long time) after being treated unsuccessfully with 1 or more medications. Ibrutinib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop the spread of cancer cells.
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[1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
[2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
[3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
[4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.
[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.
[6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
[8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/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.
[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.
[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.
[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".