NDC codes

FDA NDC Directory
Product NDC (as listed)72974-120Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72974-0120Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
72974-120-01729740120017297401200130 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72974-120-01)Marketed from Dec 18, 2020
72974-120-95729740120957297401209516 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72974-120-95)Marketed from Jan 27, 2023 · Sample package
72974-120-97729740120977297401209730 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

N472974012001 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

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