NDC 55292-139 Signifor Lar
Pasireotide Kit - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
- 55292 - Recordati Rare Diseases, Inc.
- 55292-139 - Signifor Lar
Product Packages
NDC Code 55292-139-01
Package Description: 1 KIT in 1 KIT * 6 mL in 1 VIAL, SINGLE-USE (55292-134-01) * 2 mL in 1 SYRINGE
Product Details
What is NDC 55292-139?
What are the uses for Signifor Lar?
Which are Signifor Lar UNII Codes?
The UNII codes for the active ingredients in this product are:
- PASIREOTIDE (UNII: 98H1T17066)
- PASIREOTIDE (UNII: 98H1T17066) (Active Moiety)
Which are Signifor Lar 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:
- POLY(DL-LACTIC-CO-GLYCOLIC ACID), (50:50; 63000 MW) (UNII: QD923V64H3)
- POLY(DL-LACTIC-CO-GLYCOLIC ACID), (50:50; 12000 MW) (UNII: WE369X5600)
- MANNITOL (UNII: 3OWL53L36A)
- CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
- POLOXAMER 188 (UNII: LQA7B6G8JG)
- WATER (UNII: 059QF0KO0R)
What is the NDC to RxNorm Crosswalk for Signifor Lar?
- RxCUI: 1597596 - pasireotide LAR 20 MG Injection
- RxCUI: 1597596 - pasireotide 20 MG Injection
- RxCUI: 1597596 - pasireotide LAR (as pasireotide pamoate) 20 MG Injection
- RxCUI: 1597599 - Signifor LAR 20 MG Injection
- RxCUI: 1597599 - pasireotide 20 MG Injection [Signifor]
* Please review the disclaimer below.
Patient Education
Pasireotide Injection
Pasireotide injection (Signifor and Signifor LAR) is used to treat Cushing's disease (an abnormal condition that is caused by excess hormones [cortisol]) in adults who cannot be treated with surgery or who did not respond to surgery. Pasireotide injection (Signifor LAR) is also used to decrease the amount of growth hormone (a natural substance) produced by people with acromegaly (condition in which the body produces too much growth hormone, causing enlargement of the hands, feet, and facial features; joint pain; and other symptoms) who cannot be treated with surgery or who did not respond to surgery. Pasireotide injection is in a class of medications called somatostatin agonists. It works by decreasing the amounts of cortisol produced by the body.
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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.
[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.
[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".