NDC 47335-237 Ambrisentan
Tablet, Film Coated Oral - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
- 47335 - Sun Pharmaceutical Industries, Inc.
- 47335-237 - Ambrisentan
Product Characteristics
PINK (C48328 - DEEP PINK)
OVAL (C48345)
10 MM
237
Product Packages
NDC Code 47335-237-64
Package Description: 3 BLISTER PACK in 1 CARTON / 10 TABLET, FILM COATED in 1 BLISTER PACK (47335-237-60)
NDC Code 47335-237-66
Package Description: 1 BLISTER PACK in 1 CARTON / 10 TABLET, FILM COATED in 1 BLISTER PACK (47335-237-60)
NDC Code 47335-237-83
Package Description: 30 TABLET, FILM COATED in 1 BOTTLE
NDC Code 47335-237-85
Package Description: 10 TABLET, FILM COATED in 1 BOTTLE
Product Details
What is NDC 47335-237?
What are the uses for Ambrisentan?
What are Ambrisentan Active Ingredients?
Which are Ambrisentan UNII Codes?
The UNII codes for the active ingredients in this product are:
- AMBRISENTAN (UNII: HW6NV07QEC)
- AMBRISENTAN (UNII: HW6NV07QEC) (Active Moiety)
Which are Ambrisentan 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:
- ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
- CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
- MAGNESIUM STEARATE (UNII: 70097M6I30)
- MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
- FD&C RED NO. 40 (UNII: WZB9127XOA)
- LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
- POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
- TALC (UNII: 7SEV7J4R1U)
- TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
- POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)
- SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
- ALUMINUM OXIDE (UNII: LMI26O6933)
What is the NDC to RxNorm Crosswalk for Ambrisentan?
- RxCUI: 722116 - ambrisentan 10 MG Oral Tablet
- RxCUI: 722122 - ambrisentan 5 MG Oral Tablet
Which are the Pharmacologic Classes for Ambrisentan?
* Please review the disclaimer below.
Patient Education
Ambrisentan
Ambrisentan is used alone or in combination with tadalafil (Adcirca, Cialis) to treat pulmonary arterial hypertension (PAH, high blood pressure in the vessels that carry blood to the lungs). Ambrisentan may improve the ability to exercise and slow the worsening of symptoms in people with PAH. Ambrisentan 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".