NDC 60505-4318 Tolvaptan
Tablet Oral - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
- 60505 - Apotex Corp.
- 60505-4318 - Tolvaptan
Product Characteristics
Product Packages
NDC Code 60505-4318-0
Package Description: 1 BLISTER PACK in 1 CARTON / 10 TABLET in 1 BLISTER PACK
Product Details
What is NDC 60505-4318?
What are the uses for Tolvaptan?
What are Tolvaptan Active Ingredients?
- TOLVAPTAN 30 mg/1 - A benzazepine derivative and selective VASOPRESSIN V2 RECEPTOR antagonist that is used to treat euvolemic and hypervolemic HYPONATREMIA. It is also used in the treatment of rapidly progressing AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE to slow the rate of cyst development and renal insufficiency.
Which are Tolvaptan UNII Codes?
The UNII codes for the active ingredients in this product are:
- TOLVAPTAN (UNII: 21G72T1950)
- TOLVAPTAN (UNII: 21G72T1950) (Active Moiety)
Which are Tolvaptan 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)
- SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
- COPOVIDONE K25-31 (UNII: D9C330MD8B)
- CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
- MAGNESIUM STEARATE (UNII: 70097M6I30)
- FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
What is the NDC to RxNorm Crosswalk for Tolvaptan?
- RxCUI: 849827 - tolvaptan 15 MG Oral Tablet
- RxCUI: 849833 - tolvaptan 30 MG Oral Tablet
Which are the Pharmacologic Classes for Tolvaptan?
* Please review the disclaimer below.
Patient Education
Tolvaptan (kidney disease)
Tolvaptan (Jynarque) is used to slow the worsening of kidney function in certain patients with autosomal dominant polycystic kidney disease (ADPKD; a certain type of inherited kidney disease). Tolvaptan (Jynarque) is in a class of medications called vasopressin V2 receptor antagonists. It works by increasing the amount of water released from the body as urine and decreases the growth of cysts in the kidneys. Removing fluid from the body and slowing the growth of cysts helps to slow the worsening of kidney function. Tolvaptan is also available as a tablet (Samsca) to treat low blood levels of sodium in people who have heart failure or certain other conditions. This monograph only gives information about tolvaptan tablets (Jynarque) to slow the worsening of kidney function in patients with ADPKD. If you are using this medication to treat low levels of sodium in the blood, read the monograph entitled tolvaptan (low blood sodium).
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Tolvaptan (low blood sodium)
Tolvaptan (Samsca) is used to treat hyponatremia (low levels of sodium in the blood) in people who have heart failure (condition in which the heart cannot pump enough blood to all parts of the body), syndrome of inappropriate antidiuretic hormone (SIADH; condition in which the body produces too much of a certain natural substance that causes the body to retain water) or other conditions. Tolvaptan is in a class of medications called vasopressin V2 receptor antagonists. It works by increasing the amount of water released from the body as urine. Removing fluid from the body helps to increase the level of sodium 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".