Prescription drug · ANDA
Finasteride NDC 57237-061
Finasteride 1 mg/1 · Tablet, Film coated · Oral · Rising Pharma Holdings, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 57237-061-30 | 57237006130 | 30 TABLET, FILM COATED in 1 BOTTLE (57237-061-30)Marketed from Nov 5, 2013 | |
| 57237-061-90 | 57237006190 | 90 TABLET, FILM COATED in 1 BOTTLE (57237-061-90)Marketed from Nov 5, 2013 |
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 — 1 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Rising Pharma Holdings, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203687
- Marketing start
- Listing expires
- Other FDA classes
- 5-alpha Reductase Inhibitors (Mechanism)
- Identifiers
- Product ID 57237-061_2afe9ff4-1cd2-4392-8e11-8e6ea24a68afSPL ID 2afe9ff4-1cd2-4392-8e11-8e6ea24a68afSPL set ID 01b88593-99d3-4dd6-a7b6-5438c15bd7b7RxCUI 200172UNII 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
N457237006130followed by a unit qualifier and the quantityPackage 57237-0061-30. 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)
Finasteride tablets are indicated for the treatment of male pattern hair loss (androgenetic alopecia) in MEN ONLY . Efficacy in bitemporal recession has not been established. Finasteride tablets are not indicated for use in women. Finasteride is a 5α-reductase inhibitor indicated for the treatment of male pattern hair loss (androgenetic alopecia) in MEN ONLY (1) . Finasteride tablets are not indicated for use in women ( 1 , 4 , 5.1 ).
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 203687
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 1 mg/1 | Tablet, Film coatedOral | Burel Pharmaceuticals, LLC | 35573-400 |
| Finasteride | Finasteride 1 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-151 |
| Finasteride | Finasteride 1 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4687 |
| Finasteride | Finasteride 1 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-6875 |
| Finasteride | Finasteride 1 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-4808 |
| Finasteride | Finasteride 1 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-3993 |
| Finasteride | Finasteride 1 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-927 |