NDC 66215-103 Tracleer
Bosentan Tablet, For Suspension Oral - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
- 66215 - Actelion Pharmaceuticals Us, Inc.
- 66215-103 - Tracleer
Product Characteristics
YELLOW (C48330 - PALE YELLOW TO OFF-WHITE)
OVAL (C48345)
CLOVER (C48337)
11 MM
10 MM
125
32
4
Product Packages
NDC Code 66215-103-56
Package Description: 4 BLISTER PACK in 1 CARTON / 14 TABLET, FOR SUSPENSION in 1 BLISTER PACK (66215-103-14)
Product Details
What is NDC 66215-103?
What are the uses for Tracleer?
What are Tracleer Active Ingredients?
- BOSENTAN 32 mg/1 - A sulfonamide and pyrimidine derivative that acts as a dual endothelin receptor antagonist used to manage PULMONARY HYPERTENSION and SYSTEMIC SCLEROSIS.
Which are Tracleer UNII Codes?
The UNII codes for the active ingredients in this product are:
- BOSENTAN (UNII: Q326023R30)
- BOSENTAN ANHYDROUS (UNII: XUL93R30K2) (Active Moiety)
Which are Tracleer 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:
- STARCH, CORN (UNII: O8232NY3SJ)
- SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
- POVIDONE K90 (UNII: RDH86HJV5Z)
- GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)
- MAGNESIUM STEARATE (UNII: 70097M6I30)
- HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
- TRIACETIN (UNII: XHX3C3X673)
- TALC (UNII: 7SEV7J4R1U)
- TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
- FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
- FERRIC OXIDE RED (UNII: 1K09F3G675)
- ETHYLCELLULOSE, UNSPECIFIED (UNII: 7Z8S9VYZ4B)
- MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
- ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
- CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
- SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
- TARTARIC ACID (UNII: W4888I119H)
- ASPARTAME (UNII: Z0H242BBR1)
- ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
- PHENYLALANINE (UNII: 47E5O17Y3R)
What is the NDC to RxNorm Crosswalk for Tracleer?
- RxCUI: 1989081 - bosentan 32 MG Tablet for Oral Suspension
- RxCUI: 1989085 - Tracleer 32 MG Tablet for Oral Suspension
- RxCUI: 1989085 - bosentan 32 MG Tablet for Oral Suspension [Tracleer]
- RxCUI: 349253 - bosentan 62.5 MG Oral Tablet
- RxCUI: 349253 - bosentan (as bosentan hydrochloride) 62.5 MG Oral Tablet
Which are the Pharmacologic Classes for Tracleer?
* Please review the disclaimer below.
Patient Education
Bosentan
Bosentan is used to treat pulmonary arterial hypertension (PAH, high blood pressure in the vessels that carry blood to the lungs) in adults and children 3 years of age and older. Bosentan may improve the ability to exercise and slow the worsening of symptoms in patients with PAH. Bosentan is in a class of medications called endothelin receptor antagonists. It works by stopping the action of endothelin, a natural substance that causes blood vessels to narrow and prevents normal blood flow in people who have PAH.
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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".