Finasteride
- Product NDC
- 68645-541
- 11-digit product format
- 686450541
- Labeler code
- 68645
- Product ID
- 68645-541_4c221995-67cb-49dd-e063-6294a90a2aef
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Finasteride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Legacy Pharmaceutical Packaging, LLC
- Application
- ANDA090061
- Marketing category
- ANDA
- Marketing start
- 2015-06-13
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Finasteride
- Listing expiration
- 2027-12-31
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 |
|---|
| 68645-541-54 | Finasteride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68645-541 | FINASTERIDE TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING, LLC] | 9 | Current NDC, Legacy NDC, 1 package rows | 20250316_a3b49681-09b3-4c26-bb57-3dfd598d48b6.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 |
|---|
| 68645-541-54 | 68645054154 | 30 TABLET, FILM COATED in 1 BOTTLE (68645-541-54) | 2015-06-13 | 0000-00-00 | No | No | Current |