NDC 55513-221 Nplate
Romiplostim Injection, Powder, Lyophilized, For Solution Subcutaneous - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
Code Structure Chart
Product Details
What is NDC 55513-221?
What are the uses for Nplate?
What are Nplate Active Ingredients?
Which are Nplate UNII Codes?
The UNII codes for the active ingredients in this product are:
- ROMIPLOSTIM (UNII: GN5XU2DXKV)
- ROMIPLOSTIM (UNII: GN5XU2DXKV) (Active Moiety)
Which are Nplate 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:
- HYDROCHLORIC ACID (UNII: QTT17582CB)
- HISTIDINE (UNII: 4QD397987E)
- MANNITOL (UNII: 3OWL53L36A)
- POLYSORBATE 20 (UNII: 7T1F30V5YH)
- SUCROSE (UNII: C151H8M554)
What is the NDC to RxNorm Crosswalk for Nplate?
- RxCUI: 1728092 - romiPLOStim 250 MCG Injection
- RxCUI: 1728092 - romiplostim 0.25 MG Injection
- RxCUI: 1728092 - romiplostim 250 MCG Injection
- RxCUI: 1728095 - Nplate 250 MCG Injection
- RxCUI: 1728095 - romiplostim 0.25 MG Injection [Nplate]
Which are the Pharmacologic Classes for Nplate?
* Please review the disclaimer below.
Patient Education
Romiplostim Injection
Romiplostim injection is used to increase the number of platelets (cells that help the blood to clot) in order to decrease the risk of bleeding in adults who have immune thrombocytopenia (ITP; idiopathic thrombocytopenic purpura; an ongoing condition that may cause easy bruising or bleeding due to an abnormally low number of platelets in the blood). Romiplostim injection is also used to increase the number of platelets in order to decrease the risk of bleeding in children at least 1 year of age who have had ITP for at least 6 months. Romiplostim injection should only be used in adults and children 1 year of age or older who cannot be treated or have not been helped by other treatments, including other medications or surgery to remove the spleen. Romiplostim injection should not be used to treat people who have low platelet levels caused by myelodysplastic syndrome (a group of conditions in which the bone marrow produces blood cells that are misshapen and does not produce enough healthy blood cells) or any other conditions that cause low platelet levels other than ITP. Romiplostim injection is used to increase the number of platelets enough to lower the risk of bleeding, but it is not used to increase the number of platelets to a normal level. Romiplostim is in a class of medications called thrombopoietin receptor agonists. It works by causing the cells in the bone marrow to produce more platelets.
[Learn More]
* 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".