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NDC 0074-1017 Oriahnn

Elagolix And Estradiol And Norethisterone Kit - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 0074-1017?
  5. Oriahnn Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Patient Education

Product Information

NDC Product Code:
0074-1017
Proprietary Name:
Oriahnn
Non-Proprietary Name: [1]
Elagolix And Estradiol And Norethisterone
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Kit - A packaged collection of related material.
Labeler Name: [5]
Abbvie Inc.
Labeler Code:
0074
Product Label ID:
99f6eee7-7e52-6999-7eb8-488d06dd1710
FDA Application Number: [6]
NDA213388
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date: [9]
05-29-2020
Listing Expiration Date: [11]
12-31-2024
Exclude Flag: [12]
N
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325 - WHITE)
YELLOW (C48330 - YELLOW)
BLUE (C48333 - LIGHT BLUE)
Shape:
CAPSULE (C48336)
Size(s):
16 MM
Imprint(s):
EL;300;AM
EL;300;PM
Score:
1

Code Structure Chart

Product Details

What is NDC 0074-1017?

The NDC code 0074-1017 is assigned by the FDA to the product Oriahnn which is a human prescription drug product labeled by Abbvie Inc.. The generic name of Oriahnn is elagolix and estradiol and norethisterone. The product's dosage form is kit. The product is distributed in 2 packages with assigned NDC codes 0074-1017-14 1 blister pack in 1 carton / 1 kit in 1 blister pack * 7 capsule in 1 blister pack * 7 capsule in 1 blister pack, 0074-1017-56 4 blister pack in 1 carton / 1 kit in 1 blister pack * 7 capsule in 1 blister pack * 7 capsule in 1 blister pack. 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 Oriahnn?

ORIAHNN is indicated for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women.Limitation of Use:Use of ORIAHNN should be limited to 24 months due to the risk of continued bone loss, which may not be reversible [see Dosage and Administration (2.1) and Warnings and Precautions (5.2)].

Which are Oriahnn UNII Codes?

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

Which are Oriahnn 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 Oriahnn?

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:
  • RxCUI: 2371764 - elagolix 300 MG / estradiol 1 MG / norethindrone 0.5 MG Oral Capsule
  • RxCUI: 2371766 - elagolix 300 MG Oral Capsule
  • RxCUI: 2371767 - {28 (elagolix 300 MG / estradiol 1 MG / norethindrone 0.5 MG Oral Capsule) / 28 (elagolix 300 MG Oral Capsule) } Pack
  • RxCUI: 2371767 - (elagolix 300 MG / estradiol 1 MG / norethindrone 0.5 MG (28) Oral Capsule) / (elagolix 300 MG (28) Oral Capsule) Pack
  • RxCUI: 2371768 - {28 (elagolix 300 MG / estradiol 1 MG / norethindrone 0.5 MG Oral Capsule) / 28 (elagolix 300 MG Oral Capsule) } Pack [Oriahnn 28 Day Kit]

* Please review the disclaimer below.

Patient Education

Elagolix


Elagolix is used to manage pain due to endometriosis (a condition in which the type of tissue that lines the uterus [womb] grows in other areas of the body and causes infertility, pain before and during menstrual periods, pain during and after sexual activity, and heavy or irregular bleeding). Elagolix is in a class of medications called gonadotropin-releasing hormone (GnRH) receptor antagonists. It works by decreasing the amount of certain hormones in the body.
[Learn More]


Elagolix, Estradiol, and Norethindrone


The combination of elagolix, estradiol, and norethindrone is used to treat heavy menstrual bleeding caused by uterine fibroids (growths in the uterus that are not cancer). Elagolix is in a class of medications called gonadotropin-releasing hormone (GnRH) receptor antagonists. Estradiol is in a class of medications called estrogen hormones. Norethindrone is in a class of medications called progestins. Elagolix works by decreasing the amount of certain hormones in the body. Estradiol works by replacing estrogen that is normally produced by the body. Norethindrone works by stopping the lining of the uterus from growing and by causing the uterus to produce certain hormones.
[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.

[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".