Prescription drug · ANDA
Finasteride NDC 72189-542
Finasteride 5 mg/1 · Tablet, Film coated · Oral · Direct_Rx
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72189-542-30 | 72189054230 | 30 TABLET, FILM COATED in 1 BOTTLE (72189-542-30)Marketed from Mar 11, 2024 | |
| 72189-542-90 | 72189054290 | 90 TABLET, FILM COATED in 1 BOTTLE (72189-542-90)Marketed from Mar 11, 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)
- Finasteride
- Generic name (nonproprietary)
- finasteride
- Active ingredients
- Finasteride — 5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Direct_Rx
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204304
- Marketing start
- Listing expires
- Other FDA classes
- 5-alpha Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 72189-542_4615ec4d-f6e1-70c0-e063-6394a90a154fSPL ID 4615ec4d-f6e1-70c0-e063-6394a90a154fSPL set ID 13673a09-8a50-5cd0-e063-6294a90a3d5bRxCUI 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
N472189054230followed by a unit qualifier and the quantityPackage 72189-0542-30. 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)
1.1 Monotherapy Finasteride tablets are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: - 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. 1.2 Combination with Alpha-Blocker 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). 1.3 Limitations of Use Finasteride tablets are not approved for the prevention of prostate c…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 204304
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 | REMEDYREPACK INC. | 70518-3600 |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8433 |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-2999 |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-520 |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7086 |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-4697 |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | Ascend Laboratories, LLC | 67877-288 |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1898 |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-767 |