Oriahnn Kit
NDC Package 0074-1017-56

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Oriahnn (elagolix and estradiol and norethisterone) kits is 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)]. This formulation utilizes a kit delivery system. Marketed by Abbvie Inc., this product is identified by NDC 0074-1017 and is authorized under FDA application NDA213388.

Identification & Billing

NDC Package Code
0074-1017-56
Package Description
4 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK * 7 CAPSULE in 1 BLISTER PACK * 7 CAPSULE in 1 BLISTER PACK
Product Code
0074-1017
11-Digit Billing Format
00074101756
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
RxNorm Crosswalk
  • 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]

Clinical Specifications

Proprietary Name
Oriahnn
Non-Proprietary Name
Elagolix And Estradiol And Norethisterone
Dosage Form
Kit - A packaged collection of related material.
Usage Information
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)].

Regulatory & Marketing

Labeler Name
Abbvie Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA213388
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
05-29-2020
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0074-1017). Click a package code to view its specific billing and regulatory data.

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

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0074-1017-56 identifies a specific commercial package of 4 blister pack in 1 carton / 1 kit in 1 blister pack * 7 capsule in 1 blister pack * 7 capsule in 1 blister pack of Oriahnn, a human prescription drug labeled by Abbvie Inc.. This kit is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Abbvie Inc. on May 29, 2020. The current certification is valid through December 31, 2026.

How is this Abbvie Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00074101756. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (4-4-2)
0074-1017-56
11-Digit CMS (5-4-2)
00074-1017-56

Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.