Prescription drug · ANDA
Finasteride NDC 68071-3234
Finasteride 5 mg/1 · Tablet, Film coated · Oral · NuCare Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-3234-9 | 6807132340968071323409 | 90 TABLET, FILM COATED in 1 BOTTLE (68071-3234-9)Marketed from Jan 22, 2018 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Finasteride
- Generic name (nonproprietary)
- finasteride
- Active ingredients
- Finasteride — 5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- NuCare Pharmaceuticals,Inc.NDC labeler code 68071
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078341
- Marketing start
- Listing expires
- Other FDA classes
- 5-alpha Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 68071-3234_2d53fd2d-b54d-3fb5-e063-6294a90ab6bbSPL ID 2d53fd2d-b54d-3fb5-e063-6294a90ab6bbSPL set ID 6360d8cc-72df-c571-e053-2991aa0a72c5RxCUI 310346UNII 57GNO57U7GUPC 0368071323498
- Pharmacologic class
- 5-alpha Reductase 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
N468071323409followed by a unit qualifier and the quantityPackage 68071-3234-09. 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)
Finasteride, is a 5α-reductase inhibitor, indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to (1.1) : Improve symptoms Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy. Finasteride tablets, USP administered in combination with the alpha-blocker doxazosin is indicated to reduce the risk of symptomatic progression of BPH (a confirmed ≥4 point increase in American Urological Association (AUA) symptom score) (1.2) . Limitations of Use: Finasteride tablets, USP are not approved for the prevention of prostate cancer (1.3) . 1.1 Monotherapy Finasteride tablets, USP are ind…
Excerpt only. Read the full label for complete information.
About NDC 68071-3234
- What is NDC 68071-3234?
- 68071-3234 is the product NDC for Finasteride, Finasteride 5 mg/1 tablet, film coated, listed with the FDA by NuCare Pharmaceuticals,Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Finasteride.
- What is the active ingredient?
- Finasteride.
- Who is the labeler?
- NuCare Pharmaceuticals,Inc., NDC labeler code 68071. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Finasteride?
- 68 other product NDCs are listed under this name. See all Finasteride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Finasteride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Finasteride | Finasteride 1 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4687 | 70518-4687-00 |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1058 | 67046-1058-03 |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-2639 | 55154-2639-00 |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8749 | 68788-8749-0168788-8749-0368788-8749-06+1 more |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8433 | 68788-8433-0168788-8433-0368788-8433-06+1 more |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-542 | 72189-0542-3072189-0542-90 |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals, Inc. | 68788-8377 | 68788-8377-0168788-8377-0368788-8377-06+1 more |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-3616 | 70518-3616-0170518-3616-0370518-3616-04+1 more |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-3600 | 70518-3600-0170518-3600-0370518-3600-04 |
| Finasteride | Finasteride 1 mg/1 | Tablet, Film coatedOral | Sun Pharmaceutical Industries, Inc. | 47335-714 | 47335-0714-0847335-0714-1847335-0714-81+2 more |
Other NDCs under ANDA 078341
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 |
|---|---|---|---|---|
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6940 |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6941 |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 57237-062 |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-428 |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-1585 |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1058 |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-3417 |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-3785 |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8749 |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-1704 |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-3616 |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1530 |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-154 |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | QUALLENT PHARMACEUTICALS HEALTH LLC | 82009-061 |