Prescription drug · NDA
Orgovyx (Relugolix) NDC 72974-120
Relugolix 120 mg/1 · Tablet, Film coated · Oral · Sumitomo Pharma America, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72974-120-01 | 7297401200172974012001 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72974-120-01)Marketed from Dec 18, 2020 | |
| 72974-120-95 | 7297401209572974012095 | 16 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72974-120-95)Marketed from Jan 27, 2023 · Sample package | |
| 72974-120-97 | 7297401209772974012097 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72974-120-97)Marketed from Oct 21, 2021 · Sample package |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Orgovyx
- Generic name (nonproprietary)
- relugolix
- Active ingredients
- Relugolix — 120 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Sumitomo Pharma America, Inc.NDC labeler code 72974
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 214621
- Marketing start
- Listing expires
- Other FDA classes
- Breast Cancer Resistance Protein Inhibitors (Mechanism)Cytochrome P450 2B6 Inducers (Mechanism)Cytochrome P450 3A Inducers (Mechanism)Decreased GnRH Secretion (Physiologic effect)Gonadotropin Releasing Hormone Receptor Antagonists (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
- Identifiers
- Product ID 72974-120_0d9200dd-878e-4e93-98af-e1149e84c21fSPL ID 0d9200dd-878e-4e93-98af-e1149e84c21fSPL set ID 077a92f6-9f1b-479a-87c7-c92b5db6aa9cRxCUI 2472783, 2472789UNII P76B05O5V6
- 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
N472974012001followed by a unit qualifier and the quantityPackage 72974-0120-01. 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)
ORGOVYX is indicated for the treatment of adult patients with advanced prostate cancer. ORGOVYX is a gonadotropin-releasing hormone (GnRH) receptor antagonist indicated for the treatment of adult patients with advanced prostate cancer ( 1 ).
Excerpt only. Read the full label for complete information.
About NDC 72974-120
- What is NDC 72974-120?
- 72974-120 is the product NDC for Orgovyx (relugolix), Relugolix 120 mg/1 tablet, film coated, listed with the FDA by Sumitomo Pharma America, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Orgovyx (Relugolix).
- What is the active ingredient?
- Relugolix.
- Who is the labeler?
- Sumitomo Pharma America, Inc., NDC labeler code 72974. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Orgovyx?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.