Prescription drug · ANDA
Eulexin (Flutamide) NDC 80725-600
Flutamide 125 mg/1 · Capsule · Oral · Waylis Therapeutics LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80725-600-18 | 80725060018 | 1 BOTTLE, PLASTIC in 1 BOX (80725-600-18) / 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 LLCNDC labeler code 80725
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 075298
- Marketing start
- Listing expires
- Other FDA classes
- Androgen Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 80725-600_7c581273-b507-4c4b-bcda-fa67a21b1c56SPL ID 7c581273-b507-4c4b-bcda-fa67a21b1c56SPL set ID 56b6ba36-9b49-4422-a2a4-7bfa0d941a5dRxCUI 197726, 205646UNII 76W6J0943EUPC 0380725600182
- 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
N480725060018followed by a unit qualifier and the quantityPackage 80725-0600-18. 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 . 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.
About NDC 80725-600
- What is NDC 80725-600?
- 80725-600 is the product NDC for Eulexin (flutamide), Flutamide 125 mg/1 capsule, listed with the FDA by Waylis Therapeutics LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Eulexin (Flutamide).
- What is the active ingredient?
- Flutamide.
- Who is the labeler?
- Waylis Therapeutics LLC, NDC labeler code 80725. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Eulexin?
- 1 other product NDC are listed under this name. See all Eulexin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Eulexin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Eulexinflutamide | Flutamide 125 mg/1 | CapsuleOral | Waylis Therapeutics LLC | 80725-143 | 80725-0143-18 |
Other NDCs under ANDA 075298
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 |
|---|---|---|---|---|
| Eulexinflutamide | Flutamide 125 mg/1 | CapsuleOral | Waylis Therapeutics LLC | 80725-143 |