Prescription drug · NDA
Oriahnn NDC 0074-1017
elagolix and estradiol and norethisterone · Kit · AbbVie Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0074-1017-14 | 00074101714 | 1 BLISTER PACK in 1 CARTON (0074-1017-14) / 1 KIT in 1 BLISTER PACK * 7 CAPSULE in 1 BLISTER PACK * 7 CAPSULE in 1 BLISTER PACKMarketed from Sep 24, 2020 · Sample package | |
| 0074-1017-56 | 00074101756 | 4 BLISTER PACK in 1 CARTON (0074-1017-56) / 1 KIT in 1 BLISTER PACK * 7 CAPSULE in 1 BLISTER PACK * 7 CAPSULE in 1 BLISTER PACKMarketed from May 29, 2020 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Oriahnn
- Generic name (nonproprietary)
- elagolix and estradiol and norethisterone
- Dosage form
- Kit
- Labeler
- AbbVie Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 213388
- Marketing start
- Listing expires
- Identifiers
- Product ID 0074-1017_92a6192f-7a2b-4bb7-be46-4664e07dcf44SPL ID 92a6192f-7a2b-4bb7-be46-4664e07dcf44SPL set ID 99f6eee7-7e52-6999-7eb8-488d06dd1710RxCUI 2371764, 2371766, 2371767, 2371768
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N400074101714followed by a unit qualifier and the quantityPackage 00074-1017-14. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
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 ) ] . ORIAHNN is a combination of elagolix, a gonadotropin-releasing hormone (GnRH) receptor antagonist, estradiol, an estrogen, and norethindrone acetate, a progestin, indicated for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women. ( 1 ) Limitation of Use: Use of ORIAHNN should be limited t…
Excerpt only. Read the full label for complete information.