Prescription drug · ANDA
Finasteride NDC 70518-3616
Finasteride 5 mg/1 · Tablet, Film coated · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-3616-1 | 70518361601 | 30 POUCH in 1 BOX (70518-3616-1) / 1 TABLET, FILM COATED in 1 POUCH (70518-3616-2)Marketed from Feb 10, 2023 | |
| 70518-3616-3 | 70518361603 | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-3616-3)Marketed from May 10, 2023 | |
| 70518-3616-4 | 70518361604 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3616-4)Marketed from Jan 25, 2024 | |
| 70518-3616-5 | 70518361605 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3616-5)Marketed from Aug 7, 2024 |
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 078341
- Marketing start
- Listing expires
- Other FDA classes
- 5-alpha Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 70518-3616_536d2227-e887-c8c3-e063-6294a90a69ffSPL ID 536d2227-e887-c8c3-e063-6294a90a69ffSPL set ID e482a50d-db15-4407-85c9-160c88e8a657RxCUI 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
N470518361601followed by a unit qualifier and the quantityPackage 70518-3616-01. 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, 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 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 are 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 Monotherap…
Excerpt only. Read the full label for complete information.
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 | Asclemed USA, Inc. | 76420-154 |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-1704 |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-428 |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-149 |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8749 |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-3234 |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | QUALLENT PHARMACEUTICALS HEALTH LLC | 82009-061 |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1530 |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-3417 |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-1585 |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 57237-062 |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1058 |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-3785 |
| 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 |