Prescription drug · ANDA
Finasteride NDC 68788-8377
Finasteride 5 mg/1 · Tablet, Film coated · Oral · Preferred Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-8377-1 | 6878883770168788837701 | 100 TABLET, FILM COATED in 1 BOTTLE (68788-8377-1)Marketed from Feb 28, 2023 | |
| 68788-8377-3 | 6878883770368788837703 | 30 TABLET, FILM COATED in 1 BOTTLE (68788-8377-3)Marketed from Feb 28, 2023 | |
| 68788-8377-6 | 6878883770668788837706 | 60 TABLET, FILM COATED in 1 BOTTLE (68788-8377-6)Marketed from Feb 28, 2023 | |
| 68788-8377-9 | 6878883770968788837709 | 90 TABLET, FILM COATED in 1 BOTTLE (68788-8377-9)Marketed from Feb 28, 2023 |
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
- Preferred Pharmaceuticals, Inc.NDC labeler code 68788
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090061
- Marketing start
- Listing expires
- Other FDA classes
- 5-alpha Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 68788-8377_eeb61a34-d202-4426-8035-60d0971daf5dSPL ID eeb61a34-d202-4426-8035-60d0971daf5dSPL set ID 9ae38bf5-17d7-4af1-922f-b3edb1e65392RxCUI 310346UNII 57GNO57U7G
- 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
N468788837701followed by a unit qualifier and the quantityPackage 68788-8377-01. 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 tablets, are 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 acute urinary retention • Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy. Finasteride tablets 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 are not approved for the prevention of prostate cancer (1.3). 1.1…
Excerpt only. Read the full label for complete information.
About NDC 68788-8377
- What is NDC 68788-8377?
- 68788-8377 is the product NDC for Finasteride, Finasteride 5 mg/1 tablet, film coated, listed with the FDA by Preferred Pharmaceuticals, Inc.. It has 4 package NDCs, 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?
- Preferred Pharmaceuticals, Inc., NDC labeler code 68788. 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 | 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 |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | QUALLENT PHARMACEUTICALS HEALTH LLC | 82009-061 | 82009-0061-05 |
Other NDCs under ANDA 090061
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 | Camber Pharmaceuticals, Inc. | 31722-525 |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-314 |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6830 |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-1936 |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-2639 |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-8083 |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-3182 |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | Legacy Pharmaceutical Packaging, LLC | 68645-541 |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | Exelan Pharmaceuticals Inc. | 76282-412 |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7228 |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-515 |