NDC 0002-8400 Forteo
Teriparatide Injection, Solution Subcutaneous - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
Code Structure Chart
Product Details
What is NDC 0002-8400?
What are the uses for Forteo?
What are Forteo Active Ingredients?
- TERIPARATIDE 250 ug/mL - A polypeptide that consists of the 1-34 amino-acid fragment of human PARATHYROID HORMONE, the biologically active N-terminal region. The acetate form is given by intravenous infusion in the differential diagnosis of HYPOPARATHYROIDISM and PSEUDOHYPOPARATHYROIDISM. (Reynolds JEF(Ed): Martindale: The Extra Pharmacopoeia (electronic version). Micromedex, Inc, Englewood, CO, 1995)
Which are Forteo UNII Codes?
The UNII codes for the active ingredients in this product are:
- TERIPARATIDE (UNII: 10T9CSU89I)
- TERIPARATIDE (UNII: 10T9CSU89I) (Active Moiety)
Which are Forteo 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:
- ACETIC ACID (UNII: Q40Q9N063P)
- SODIUM ACETATE ANHYDROUS (UNII: NVG71ZZ7P0)
- MANNITOL (UNII: 3OWL53L36A)
- METACRESOL (UNII: GGO4Y809LO)
- WATER (UNII: 059QF0KO0R)
- HYDROCHLORIC ACID (UNII: QTT17582CB)
- SODIUM HYDROXIDE (UNII: 55X04QC32I)
What is the NDC to RxNorm Crosswalk for Forteo?
- RxCUI: 1435115 - teriparatide 20 MCG/Dose in 28 Dose Pen Injector
- RxCUI: 1435115 - 28 ACTUAT teriparatide 0.02 MG/ACTUAT Pen Injector
- RxCUI: 1435115 - teriparatide 0.02 MG/ACTUAT Pen Injector, 28 ACTUAT
- RxCUI: 1435115 - teriparatide 20 MCG/ACTUAT Pen Injector, 28 ACTUAT
- RxCUI: 1435117 - FORTEO 20 MCG/Dose in 28 Dose Pen Injector
Which are the Pharmacologic Classes for Forteo?
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Patient Education
Teriparatide Injection
Teriparatide injection is used to treat osteoporosis (a condition in which the bones become thin and weak and break easily) in women who have undergone menopause ('change in life,' end of menstrual periods), who are at high risk of fractures (broken bones), and cannot use other osteoporosis treatments. It is also used to increase bone mass in men with certain types of osteoporosis who are at high risk for having broken bones (fractures), and who cannot use other osteoporosis treatments. Teriparatide injection is also used to treat osteoporosis in men and women who are taking corticosteroids (a type of medication that may cause osteoporosis in some patients) who are at high risk of fractures (broken bones), and cannot use other osteoporosis treatments. Teriparatide injection contains a synthetic form of natural human hormone called parathyroid hormone (PTH). It works by causing the body to build new bone and by increasing bone strength and density (thickness).
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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".