NDC 0310-3512 Calquence
Acalabrutinib Tablet, Film Coated Oral - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
Product Characteristics
Code Structure Chart
Product Details
What is NDC 0310-3512?
What are the uses for Calquence?
What are Calquence Active Ingredients?
Which are Calquence UNII Codes?
The UNII codes for the active ingredients in this product are:
- ACALABRUTINIB (UNII: I42748ELQW)
- ACALABRUTINIB (UNII: I42748ELQW) (Active Moiety)
Which are Calquence Inactive Ingredients UNII Codes?
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:
- COPOVIDONE K25-31 (UNII: D9C330MD8B)
- FERRIC OXIDE RED (UNII: 1K09F3G675)
- FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
- HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
- LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 2165RE0K14)
- MANNITOL (UNII: 3OWL53L36A)
- MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
- MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
- POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
- SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)
- TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
- WATER (UNII: 059QF0KO0R)
What is the NDC to RxNorm Crosswalk for Calquence?
- RxCUI: 2607734 - acalabrutinib 100 MG Oral Tablet
- RxCUI: 2607734 - acalabrutinib 100 MG (as acalabrutinib maleate 129 MG) Oral Tablet
- RxCUI: 2607737 - CALQUENCE 100 MG Oral Tablet
- RxCUI: 2607737 - acalabrutinib 100 MG Oral Tablet [Calquence]
- RxCUI: 2607737 - Calquence 100 MG Oral Tablet
Which are the Pharmacologic Classes for Calquence?
* Please review the disclaimer below.
Patient Education
Acalabrutinib
Acalabrutinib 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. It is also used alone or with obinutuzumab (Gazyva) to treat 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 in the white blood cells). Acalabrutinib 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.
[Learn More]
* Please review the disclaimer below.
[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".