Prescription drug · NDA
Bicalutamide NDC 51407-010
Bicalutamide 50 mg/1 · Tablet · Oral · Golden State Medical Supply, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51407-010-30 | 5140700103051407001030 | 30 TABLET in 1 BOTTLE (51407-010-30)Marketed from Sep 30, 2024 |
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)
- Bicalutamide
- Generic name (nonproprietary)
- bicalutamide
- Active ingredients
- Bicalutamide — 50 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Golden State Medical Supply, Inc.NDC labeler code 51407
- 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 51407-010_502406d1-aec4-1ceb-e063-6294a90a9c31SPL ID 502406d1-aec4-1ceb-e063-6294a90a9c31SPL set ID 26e30155-a50b-df14-e063-6394a90a9be4RxCUI 199123UNII A0Z3NAU9DPUPC 0351407010308
- 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
N451407001030followed by a unit qualifier and the quantityPackage 51407-0010-30. 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 Bicalutamide tablets 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. Bicalutamide tablets 150 mg daily is not approved for use alone or with other treatments [see Clinical Studies (14.2) ]. Bicalutamide tablets 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) Bicalutamide tablets 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 51407-010
- What is NDC 51407-010?
- 51407-010 is the product NDC for Bicalutamide, Bicalutamide 50 mg/1 tablet, listed with the FDA by Golden State Medical Supply, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Bicalutamide.
- What is the active ingredient?
- Bicalutamide.
- Who is the labeler?
- Golden State Medical Supply, Inc., NDC labeler code 51407. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Bicalutamide?
- 8 other product NDCs are listed under this name. See all Bicalutamide NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Bicalutamide products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Bicalutamide | Bicalutamide 50 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 62559-890 | 62559-0890-30 |
| bicalutamide | Bicalutamide 50 mg/1 | Tablet, Film coatedOral | Sun Pharmaceutical Industries, Inc. | 47335-485 | 47335-0485-0847335-0485-1847335-0485-83+1 more |
| bicalutamide | Bicalutamide 50 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 82804-082 | 82804-0082-90 |
| Bicalutamide | Bicalutamide 50 mg/1 | TabletOral | Accord Healthcare Inc. | 16729-023 | 16729-0023-0116729-0023-10 |
| Bicalutamide | Bicalutamide 50 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8308 | 63629-8308-0163629-8308-02 |
| Bicalutamide | Bicalutamide 50 mg/1 | TabletOral | Proficient Rx LP | 71205-577 | 71205-0577-3071205-0577-6071205-0577-90 |
| Bicalutamide | Bicalutamide 50 mg/1 | TabletOral | Viona Pharmaceuticals Inc. | 72578-215 | 72578-0215-0172578-0215-06 |
| Bicalutamide | Bicalutamide 50 mg/1 | TabletOral | PINNACLE LIFE SCIENCE PRIVATE LIMITED | 84508-001 | 84508-0001-0184508-0001-30 |
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 |
| Casodexbicalutamide | Bicalutamide 50 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 62559-680 |