Oriahnn Kit
NDC 0074-1017

View dosage, usage, ingredients, routes, and UNII mappings.
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

Oriahnn (elagolix and estradiol and norethisterone) is a NDA-approved product labeled by Abbvie Inc.. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a white kit. This product entry covers the primary NDC 0074-1017 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

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
Code Navigator:

Clinical Specifications

Dosage Form:
Kit - A packaged collection of related material.

Labeler & Regulatory Data

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.

Marketing Timeline

Start Marketing Date: [9]
05-29-2020
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

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. It is commonly known by its generic name, elagolix and estradiol and norethisterone. This pharmaceutical product is labeled by Abbvie Inc. and is currently categorized as listed product. The medication is a kit. In terms of distribution, this product is available in 2 different package configurations. The associated package NDC(s) include: 0074-1017-14, 0074-1017-56. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

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 the associated UNII Codes?

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

Which are the Inactive Ingredients associated 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 this product?

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 full disclaimer at the bottom of this page.

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 full disclaimer at the bottom of this page.

Product & Regulatory Definitions
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.
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.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".