Finasteride
- Product NDC
- 35573-400
- 11-digit product format
- 355730400
- Labeler code
- 35573
- Product ID
- 35573-400_6752dcb1-091e-40a9-a6e2-069d543398a7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Finasteride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Burel Pharmaceuticals, LLC
- Application
- ANDA203687
- Marketing category
- ANDA
- Marketing start
- 2018-07-13
- Substance
- FINASTERIDE
- Active strength
- 1 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 | 1 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 57GNO57U7G |
| Rxcui | 200172 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 35573-400-99 | Finasteride | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 35573-400 | FINASTERIDE TABLET, FILM COATED [BUREL PHARMACEUTICALS, LLC] | 6 | Current NDC, Legacy NDC, 1 package rows | 20240507_c8516eaa-98d0-4eb1-bc65-aa765baea5db.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 |
|---|
| 35573-400-99 | 35573040099 | 1000 TABLET, FILM COATED in 1 BOTTLE (35573-400-99) | 2018-07-13 | 0000-00-00 | No | No | Current |