Prescription drug · NDA
Orilissa (Elagolix) NDC 0074-0038
Elagolix sodium 150 mg/1 · Tablet, Film coated · Oral · AbbVie Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0074-0038-07 | 00074003807 | 1 BLISTER PACK in 1 CARTON (0074-0038-07) / 7 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jul 23, 2018 · Sample package | |
| 0074-0038-28 | 00074003828 | 4 BLISTER PACK in 1 CARTON (0074-0038-28) / 7 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jul 23, 2018 |
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)
- Orilissa
- Generic name (nonproprietary)
- elagolix
- Active ingredients
- Elagolix sodium — 150 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- AbbVie Inc.NDC labeler code 0074
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 210450
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C19 Inhibitors (Mechanism)Cytochrome P450 3A Inducers (Mechanism)Decreased GnRH Secretion (Physiologic effect)Gonadotropin Releasing Hormone Receptor Antagonists (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
- Identifiers
- Product ID 0074-0038_07f98869-6203-4e8c-b576-2ba8f0a159d7SPL ID 07f98869-6203-4e8c-b576-2ba8f0a159d7SPL set ID a86757b3-09c5-fd3b-1223-244e94f50a66RxCUI 2049852, 2049858, 2049860, 2049862UNII 5948VUI423
- Pharmacologic class
- Gonadotropin Releasing Hormone Receptor Antagonist
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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400074003807followed by a unit qualifier and the quantityPackage 00074-0038-07. 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 .
Indications (excerpt from the label)
ORILISSA is indicated for the management of moderate to severe pain associated with endometriosis. Limitation s of Use: Limit the duration of use based on the dose and coexisting condition (see Table 1 ) [see D osage and Administration ( 2.1 ) and Warnings and Precautions ( 5.1 ) ] . ORILISSA is a gonadotropin-releasing hormone (GnRH) receptor antagonist indicated for the management of moderate to severe pain associated with endometriosis. ( 1 ) Limitation s of Use: Limit the duration of use based on the dose and coexisting condition (see Table 1 ). ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 0074-0038
- What is NDC 0074-0038?
- 0074-0038 is the product NDC for Orilissa (elagolix), Elagolix sodium 150 mg/1 tablet, film coated, listed with the FDA by AbbVie Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Orilissa (Elagolix).
- What is the active ingredient?
- Elagolix sodium.
- Who is the labeler?
- AbbVie Inc., NDC labeler code 0074. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Orilissa?
- 1 other product NDC are listed under this name. See all Orilissa NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Orilissa products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Orilissaelagolix | Elagolix sodium 200 mg/1 | Tablet, Film coatedOral | AbbVie Inc. | 0074-0039 | 00074-0039-1400074-0039-56 |
Other NDCs under NDA 210450
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Orilissaelagolix | Elagolix sodium 200 mg/1 | Tablet, Film coatedOral | AbbVie Inc. | 0074-0039 |