NDC codes

FDA NDC Directory
Product NDC (as listed)62559-173Labeler and product segments. Claims need a package NDC.
Product NDC at billing width62559-0173Add 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
62559-173-31625590173313 BLISTER PACK in 1 CARTON (62559-173-31) / 10 TABLET in 1 BLISTER PACKMarketed from Jul 18, 2016

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)
Nilutamide
Generic name (nonproprietary)
nilutamide
Active ingredients
Nilutamide — 150 mg/1
Dosage form
Tablet
Route
Oral
Labeler
ANI Pharmaceuticals, Inc.NDC labeler code 62559
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 207631
Marketing start
Listing expires
Other FDA classes
Androgen Receptor Antagonists (Mechanism)
Identifiers
Product ID 62559-173_eab327c3-3ce0-4118-b1eb-76a3f247625fSPL ID eab327c3-3ce0-4118-b1eb-76a3f247625fSPL set ID d5740b8f-fbb3-4023-9133-9e359a9ab980RxCUI 311982UNII 51G6I8B902UPC 0362559173315
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

N462559017331 followed by a unit qualifier and the quantity

Package 62559-0173-31. 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 Metastatic Prostate Cancer Nilutamide Tablets are indicated for use in combination with surgical castration for the treatment of metastatic prostate cancer (Stage D 2 ). For maximum benefit, treatment with Nilutamide Tablets must begin on the same day as or on the day after surgical castration.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 62559-173

What is NDC 62559-173?
62559-173 is the product NDC for Nilutamide, Nilutamide 150 mg/1 tablet, listed with the FDA by ANI Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Nilutamide.
What is the active ingredient?
Nilutamide.
Who is the labeler?
ANI Pharmaceuticals, Inc., NDC labeler code 62559. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Nilutamide?
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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