NDC 63629-9608 Cinacalcet
Tablet, Film Coated Oral - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
Product Characteristics
Code Structure Chart
Product Details
What is NDC 63629-9608?
What are the uses for Cinacalcet?
What are Cinacalcet Active Ingredients?
Which are Cinacalcet UNII Codes?
The UNII codes for the active ingredients in this product are:
- CINACALCET HYDROCHLORIDE (UNII: 1K860WSG25)
- CINACALCET (UNII: UAZ6V7728S) (Active Moiety)
Which are Cinacalcet 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:
- LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
- MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
- CROSPOVIDONE (UNII: 2S7830E561)
- HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
- MAGNESIUM STEARATE (UNII: 70097M6I30)
- WATER (UNII: 059QF0KO0R)
- POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
- TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
- POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
- TALC (UNII: 7SEV7J4R1U)
- FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
- FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
What is the NDC to RxNorm Crosswalk for Cinacalcet?
- RxCUI: 432402 - cinacalcet HCl 30 MG Oral Tablet
- RxCUI: 432402 - cinacalcet 30 MG Oral Tablet
- RxCUI: 432402 - cinacalcet 30 MG (as cinacalcet HCl 33 MG) Oral Tablet
Which are the Pharmacologic Classes for Cinacalcet?
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Patient Education
Cinacalcet
Cinacalcet is used alone or with other medications to treat secondary hyperparathyroidism (a condition in which the body produces too much parathyroid hormone [a natural substance needed to control the amount of calcium in the blood] which can cause serious problems with the bones, heart, blood vessels, and lungs) in patients with chronic kidney disease (condition in which the kidneys stop working slowly and gradually) who are being treated with dialysis (medical treatment to clean the blood when the kidneys are not working properly). Cinacalcet is also used to treat high levels of calcium in the blood of patients who have parathyroid cancer (cancer of the glands in the neck that make parathyroid hormone). Cinacalcet is in a class of medications called calcimimetics. It works by signaling the body to produce less parathyroid hormone in order to decrease the amount of calcium in the blood.
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* 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".