Eulexin
- Product NDC
- 80725-143
- 11-digit product format
- 807250143
- Labeler code
- 80725
- Product ID
- 80725-143_497f8d4c-3d59-43d3-93ee-6bdbc391b457
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Flutamide
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Waylis Therapeutics LLC
- Application
- ANDA075298
- Marketing category
- ANDA
- Marketing start
- 2021-11-12
- Substance
- FLUTAMIDE
- Active strength
- 125 mg/1
- Pharmacologic classes
- Androgen Receptor Antagonists [MoA], Androgen Receptor Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Eulexin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FLUTAMIDE | 125 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 76W6J0943E |
| Rxcui | 197726, 205646 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 80725-143-18 | Eulexin | 180 in 1 BOTTLE, PLASTIC | CAPSULE | 180 | | 2 |
| 80725-143-18 | Eulexin | 1 in 1 BOX | CAPSULE | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 80725-143 | EULEXIN (FLUTAMIDE) CAPSULE [WAYLIS THERAPEUTICS LLC] | 2 | Current NDC, 2 package rows | 20250209_0a905e25-42b6-4937-a689-f01a8f22e644.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 80725-143-18 | 80725014318 | 1 BOTTLE, PLASTIC in 1 BOX (80725-143-18) / 180 CAPSULE in 1 BOTTLE, PLASTIC | 2021-11-12 | No | No | Current |