Finasteride
- Product NDC
- 68788-8749
- 11-digit product format
- 687888749
- Labeler code
- 68788
- Product ID
- 68788-8749_5a1f0d36-1c26-4e8a-a7b9-baf6eb6d4e42
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Finasteride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA078341
- Marketing category
- ANDA
- Marketing start
- 2024-10-11
- 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 |
|---|
| 68788-8749-1 | Finasteride | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 2 |
| 68788-8749-3 | Finasteride | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 2 |
| 68788-8749-6 | Finasteride | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 2 |
| 68788-8749-9 | Finasteride | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-8749 | FINASTERIDE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.] | 1 | Current NDC, 4 package rows | 20241013_cdde1382-a995-4f53-9497-7724d5e25b66.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-8749-1 | 68788874901 | 100 TABLET, FILM COATED in 1 BOTTLE (68788-8749-1) | 2024-10-11 | No | No | Historical |
| 68788-8749-3 | 68788874903 | 30 TABLET, FILM COATED in 1 BOTTLE (68788-8749-3) | 2024-10-11 | No | No | Historical |
| 68788-8749-6 | 68788874906 | 60 TABLET, FILM COATED in 1 BOTTLE (68788-8749-6) | 2024-10-11 | No | No | Historical |
| 68788-8749-9 | 68788874909 | 90 TABLET, FILM COATED in 1 BOTTLE (68788-8749-9) | 2024-10-11 | No | No | Historical |