NDC 68875-0203 Natpara (parathyroid Hormone)

Parathyroid Hormone Injection, Powder, Lyophilized, For Solution Subcutaneous - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
68875-0203
Proprietary Name:
Natpara (parathyroid Hormone)
Non-Proprietary Name: [1]
Parathyroid Hormone
Substance Name: [2]
Parathyroid Hormone
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
Administration Route(s): [4]
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
  • Labeler Name: [5]
    Takeda Pharmaceuticals America, Inc.
    Labeler Code:
    68875
    FDA Application Number: [6]
    BLA125511
    Marketing Category: [8]
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date: [9]
    01-23-2015
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 68875-0203-2

    Package Description: 2 CARTRIDGE in 1 CARTON / 1.13 mL in 1 CARTRIDGE (68875-0203-1)

    Product Details

    What is NDC 68875-0203?

    The NDC code 68875-0203 is assigned by the FDA to the product Natpara (parathyroid Hormone) which is a human prescription drug product labeled by Takeda Pharmaceuticals America, Inc.. The generic name of Natpara (parathyroid Hormone) is parathyroid hormone. The product's dosage form is injection, powder, lyophilized, for solution and is administered via subcutaneous form. The product is distributed in a single package with assigned NDC code 68875-0203-2 2 cartridge in 1 carton / 1.13 ml in 1 cartridge (68875-0203-1). This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Natpara (parathyroid Hormone)?

    This medication is a man-made form of parathyroid hormone, a natural substance made in your body by the parathyroid glands. Parathyroid hormone helps to regulate and maintain the balance of calcium and phosphorus in your body. This medication is used along with calcium and vitamin D to help control low blood calcium due to low levels of parathyroid hormone.

    What are Natpara (parathyroid Hormone) Active Ingredients?

    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.
    • PARATHYROID HORMONE 50 ug/.08mL - A polypeptide hormone (84 amino acid residues) secreted by the PARATHYROID GLANDS which performs the essential role of maintaining intracellular CALCIUM levels in the body. Parathyroid hormone increases intracellular calcium by promoting the release of CALCIUM from BONE, increases the intestinal absorption of calcium, increases the renal tubular reabsorption of calcium, and increases the renal excretion of phosphates.

    Which are Natpara (parathyroid Hormone) UNII Codes?

    The UNII codes for the active ingredients in this product are:

    Which are Natpara (parathyroid Hormone) 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:

    What is the NDC to RxNorm Crosswalk for Natpara (parathyroid Hormone)?

    RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

    Which are the Pharmacologic Classes for Natpara (parathyroid Hormone)?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

    * Please review the disclaimer below.

    Patient Education

    Parathyroid Hormone Injection


    Parathyroid hormone injection is used along with calcium and vitamin D to treat low levels of calcium in the blood in people with certain types of hypoparathyroidism (condition in which the body does not produce enough parathyroid hormone [PTH; a natural substance needed to control the amount of calcium in the blood].) Parathyroid hormone injection should not be used to treat low levels of calcium in the blood in people whose condition can be controlled by calcium and vitamin D alone. Parathyroid hormone injection is in a class of medications called hormones. It works by causing the body to absorb more calcium into the blood.
    [Learn More]


    * Please review the disclaimer below.

    Product Footnotes

    [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".