Prescription drug · ANDA
Finasteride NDC 71335-1530
Finasteride 5 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-1530-1 | 7133515300171335153001 | 100 TABLET, FILM COATED in 1 BOTTLE (71335-1530-1)Marketed from Dec 28, 2021 | |
| 71335-1530-2 | 7133515300271335153002 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-1530-2)Marketed from Mar 6, 2020 | |
| 71335-1530-3 | 7133515300371335153003 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-1530-3)Marketed from Dec 28, 2021 | |
| 71335-1530-4 | 7133515300471335153004 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-1530-4)Marketed from Mar 20, 2020 | |
| 71335-1530-5 | 7133515300571335153005 | 500 TABLET, FILM COATED in 1 BOTTLE (71335-1530-5)Marketed from Dec 28, 2021 | |
| 71335-1530-6 | 7133515300671335153006 | 180 TABLET, FILM COATED in 1 BOTTLE (71335-1530-6)Marketed from Dec 28, 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
- Bryant Ranch PrepackNDC labeler code 71335
- 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 71335-1530_7b1f267c-70e7-4d31-8389-c4a59ccd727bSPL ID 7b1f267c-70e7-4d31-8389-c4a59ccd727bSPL set ID 61e6cbb8-ddd2-4e07-b182-6348f216858bRxCUI 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
N471335153001followed by a unit qualifier and the quantityPackage 71335-1530-01. 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.
About NDC 71335-1530
- What is NDC 71335-1530?
- 71335-1530 is the product NDC for Finasteride, Finasteride 5 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. It has 6 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?
- Bryant Ranch Prepack, NDC labeler code 71335. 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. | 68071-3234 |
| 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 | Asclemed USA, Inc. | 76420-154 |
| Finasteride | Finasteride 5 mg/1 | Tablet, Film coatedOral | QUALLENT PHARMACEUTICALS HEALTH LLC | 82009-061 |