Finasteride
- Product NDC
- 71610-515
- 11-digit product format
- 716100515
- Labeler code
- 71610
- Product ID
- 71610-515_15466f40-4ce1-71aa-e063-6294a90a3f19
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Finasteride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA090061
- Marketing category
- ANDA
- Marketing start
- 2015-05-22
- Substance
- FINASTERIDE
- Active strength
- 5 mg/1
- Pharmacologic classes
- 5-alpha Reductase Inhibitor [EPC], 5-alpha Reductase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 57GNO57U7G | FINASTERIDE | 98319-26-7 | FINASTERIDE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71610-515-30 | 71610051530 | 30 TABLET, FILM COATED in 1 BOTTLE (71610-515-30) | 2024-04-03 | No | No | Historical |
| 71610-515-53 | 71610051553 | 60 TABLET, FILM COATED in 1 BOTTLE (71610-515-53) | 2024-04-03 | No | No | Historical |
| 71610-515-60 | 71610051560 | 90 TABLET, FILM COATED in 1 BOTTLE (71610-515-60) | 2021-01-08 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Finasteride | Aphena Pharma Solutions - Tennessee, LLC | 2024-04-05 | HUMAN PRESCRIPTION DRUG LABEL | 2 |