Finasteride
- Product NDC
- 82009-061
- 11-digit product format
- 820090061
- Labeler code
- 82009
- Product ID
- 82009-061_7e56c5b9-a7be-4413-83f2-38c0f3c688e3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Finasteride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- QUALLENT PHARMACEUTICALS HEALTH LLC
- Application
- ANDA078341
- Marketing category
- ANDA
- Marketing start
- 2022-11-21
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Finasteride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FINASTERIDE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 57GNO57U7G |
| Rxcui | 310346 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82009-061-05 | Finasteride | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 82009-061 | FINASTERIDE TABLET, FILM COATED [QUALLENT PHARMACEUTICALS HEALTH LLC] | 2 | Current NDC, Legacy NDC, 1 package rows | 20240302_5efc695c-d9fd-4892-a63f-a35cceb8d3c7.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 82009-061-05 | 82009006105 | 500 TABLET, FILM COATED in 1 BOTTLE (82009-061-05) | 2022-11-21 | 0000-00-00 | No | No | Current |