Prescription drug · ANDA
Nilutamide NDC 62559-173
Nilutamide 150 mg/1 · Tablet · Oral · ANI Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62559-173-31 | 62559017331 | 3 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
N462559017331followed by a unit qualifier and the quantityPackage 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.
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.