Eulexin (flutamide) NDC 80725-143

NDC codes

FDA NDC Directory

Product NDC (as listed)80725-143Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80725-0143Add 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 NDC	11-digit (billing)	Package	Copy
80725-143-18	80725014318	1 BOTTLE, PLASTIC in 1 BOX (80725-143-18) / 180 CAPSULE in 1 BOTTLE, PLASTICMarketed from Nov 12, 2021

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): Eulexin
Generic name (nonproprietary): flutamide
Active ingredients: Flutamide — 125 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Waylis Therapeutics LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075298
Marketing start: Nov 12, 2021
Listing expires: Dec 31, 2026
Other FDA classes: Androgen Receptor Antagonists (Mechanism)
Identifiers: Product ID 80725-143_497f8d4c-3d59-43d3-93ee-6bdbc391b457SPL ID 497f8d4c-3d59-43d3-93ee-6bdbc391b457SPL set ID 0a905e25-42b6-4937-a689-f01a8f22e644RxCUI 197726, 205646UNII 76W6J0943EUPC 0380725143184
Pharmacologic class: Androgen Receptor Inhibitor

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

N480725014318 followed by a unit qualifier and the quantity

Package 80725-0143-18. 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 Feb 4, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Eulexin ® capsules are indicated for use in combination with LHRH-agonists for the management of locally confined Stage B 2 -C and Stage D 2 metastatic carcinoma of the prostate. Stage B 2 -C Prostatic Carcinoma Treatment with Eulexin ® capsules and the goserelin acetate implant should start eight weeks prior to initiating radiation therapy and continue during radiation therapy. Stage D 2 Metastatic Carcinoma To achieve benefit from treatment, Eulexin ® capsules should be initiated with the LHRH-agonist and continued until progression.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 075298

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 075298
Product	Strength	Form · route	Labeler	Product NDC
Eulexinflutamide	Flutamide 125 mg/1	CapsuleOral	Waylis Therapeutics LLC	80725-600