Prescription drug · NDA
Casodex (Bicalutamide) NDC 62559-680
Bicalutamide 50 mg/1 · Tablet · Oral · ANI Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62559-680-30 | 62559068030 | 30 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
N462559068030followed by a unit qualifier and the quantityPackage 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.
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.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Bicalutamide | Bicalutamide 50 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 62559-890 |
| Bicalutamide | Bicalutamide 50 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-010 |