NDC codes

FDA NDC Directory
Product NDC (as listed)62559-680Labeler and product segments. Claims need a package NDC.
Product NDC at billing width62559-0680Add 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
62559-680-306255906803030 TABLET in 1 BOTTLE (62559-680-30)Marketed from Jun 26, 2018

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)
Casodex
Generic name (nonproprietary)
bicalutamide
Active ingredients
Bicalutamide — 50 mg/1
Dosage form
Tablet
Route
Oral
Labeler
ANI Pharmaceuticals, Inc.NDC labeler code 62559
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 020498
Marketing start
Listing expires
Other FDA classes
Androgen Receptor Antagonists (Mechanism)
Identifiers
Product ID 62559-680_9395c6cd-8f49-423e-839b-0c3aeb89b371SPL ID 9395c6cd-8f49-423e-839b-0c3aeb89b371SPL set ID dfee4fe7-8478-4a3e-925d-00be3cd0ab67RxCUI 108828, 199123UNII A0Z3NAU9DPUPC 0362559680301
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

N462559068030 followed by a unit qualifier and the quantity

Package 62559-0680-30. 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)

1. INDICATIONS AND USAGE CASODEX 50 mg daily is indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D 2 metastatic carcinoma of the prostate. CASODEX 150 mg daily is not approved for use alone or with other treatments [see Clinical Studies (14.2) ]. • CASODEX 50 mg is an androgen receptor inhibitor indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D 2 metastatic carcinoma of the prostate. (1) • CASODEX 150 mg daily is not approved for use alone or with other treatments. (1)

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 62559-680

What is NDC 62559-680?
62559-680 is the product NDC for Casodex (bicalutamide), Bicalutamide 50 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?
Casodex (Bicalutamide).
What is the active ingredient?
Bicalutamide.
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 Casodex?
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.

Other NDCs under NDA 020498

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

FDA NDC Directory listings under NDA 020498
ProductStrengthForm · routeLabelerProduct NDC
BicalutamideBicalutamide 50 mg/1TabletOralANI Pharmaceuticals, Inc.62559-890
BicalutamideBicalutamide 50 mg/1TabletOralGolden State Medical Supply, Inc.51407-010

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