Prescription drug · ANDA
Finasteride NDC 70518-3182
Finasteride 5 mg/1 · Tablet, Film coated · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-3182-0 | 70518318200 | 30 POUCH in 1 BOX (70518-3182-0) / 1 TABLET, FILM COATED in 1 POUCH (70518-3182-1)Marketed from Aug 5, 2021 |
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
- REMEDYREPACK INC.
- 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 70518-3182_4f565ec4-d6ed-7223-e063-6294a90a8c2fSPL ID 4f565ec4-d6ed-7223-e063-6294a90a8c2fSPL set ID c2875bc7-e811-4860-9131-da06cecc2137RxCUI 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
N470518318200followed by a unit qualifier and the quantityPackage 70518-3182-00. 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.
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 | Cardinal Health 107, LLC | 55154-8083 |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-515 |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-1936 |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | Camber Pharmaceuticals, Inc. | 31722-525 |
| 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 | Preferred Pharmaceuticals, Inc. | 68788-8377 |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-314 |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-2639 |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-6830 |