NDC 44087-1005 Saizen
Somatropin Kit Intramuscular; Subcutaneous - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
- 44087 - Emd Serono, Inc.
- 44087-1005 - Saizen
Product Packages
NDC Code 44087-1005-2
Package Description: 1 KIT in 1 CARTON * 3 mL in 1 VIAL, GLASS * 3.5 mL in 1 VIAL, GLASS
Product Details
What is NDC 44087-1005?
What are the uses for Saizen?
Which are Saizen UNII Codes?
The UNII codes for the active ingredients in this product are:
- SOMATROPIN (UNII: NQX9KB6PCL)
- SOMATROPIN (UNII: NQX9KB6PCL) (Active Moiety)
Which are Saizen 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:
- SUCROSE (UNII: C151H8M554)
- PHOSPHORIC ACID (UNII: E4GA8884NN)
- WATER (UNII: 059QF0KO0R)
- BENZYL ALCOHOL (UNII: LKG8494WBH)
What is the NDC to RxNorm Crosswalk for Saizen?
- RxCUI: 207836 - saizen 5 MG/ML Injectable Solution
- RxCUI: 207836 - somatropin 5 MG/ML Injectable Solution [Saizen]
- RxCUI: 207836 - Saizen 5 MG/ML Injectable Solution
- RxCUI: 241975 - somatropin 5 MG/ML Injectable Solution
- RxCUI: 542438 - somatropin 4.4 MG/ML Injectable Solution
* Please review the disclaimer below.
Patient Education
Somatropin
Somatropin injection is used to replace growth hormone (a natural hormone produced by your body) in adults and children with growth hormone deficiency. Somatropin injection is also used to increase growth in children with certain conditions that affect normal growth and development. Somatropin injection (Serostim) is used to increase body weight and physical endurance in patients with human immunodeficiency virus (HIV) who have HIV-associated wasting syndrome. Somatropin injection (Zorbtive) is used to treat short bowel syndrome in adults who are receiving additional nutrition or fluids from intravenous (IV) therapy. Somatropin is a human growth hormone (hGH) analog. It works by replacing growth hormones that are normally produced in the body, which may result in increased growth, body weight, and improved absorption of nutrients and fluids from the intestines.
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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.
[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.
[10] What is the End Marketing Date? - This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
[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".