NDC 58198-0059 - Profender
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 58198-0059
- Package NDCs from labels
- 58198-0059-2, 58198-0059-1, 58198-0059-3
- Manufacturer
- Elanco US Inc.
- Effective date
- 2025-11-04
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Topical Solution profender™ (emodepside/praziquantel) | Elanco US Inc. | 2025-11-04 | PRESCRIPTION ANIMAL DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58198-0059-1 | Profender | 4 in 1 BLISTER PACK | SOLUTION | 4 | 4 | |
| 58198-0059-1 | Profender | 10 in 1 BOX | SOLUTION | 10 | 4 | |
| 58198-0059-2 | Profender | 0.35 mL in 1 TUBE | SOLUTION | 0.35 | 4 | |
| 58198-0059-3 | Profender | 4 in 1 BLISTER PACK | SOLUTION | 4 | 4 | |
| 58198-0059-3 | Profender | 5 in 1 BOX | SOLUTION | 5 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 58198-0059 | PROFENDER (2-(CYCLOHEXYLCARBONYL)-1,2,3,6,7,11B-HEXAHYDRO-4H-PYRAZINO(2,1-A)ISOQUINOLIN-4-ONE, EMODEPSIDE) SOLUTION PROFENDER (2-(CYCLOHEXYLCARBONYL)-1,2,3,6,7,11B-HEXAHYDRO-4H-PYRAZINO(2,1-A)ISOQUINOLIN-4-ONE, EMODEPSIDE) KIT [ELANCO US INC.] | 3 | 5 package rows | 20240615_31f0a4ec-2a29-4de5-971b-633e109b276d.zip |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| PRAZIQUANTEL | PRAZIQUANTEL | Par Health USA, LLC | 16f2b9c4-a260-4a31-bd52-e5945913246c | 2026-08-12 | Warnings, Adverse reactions | 6490C9U457 |
| Biltricide | PRAZIQUANTEL | Bayer HealthCare Pharmaceuticals Inc. | 34ce1cdd-648e-4f1e-8512-bf3d4cc22eb9 | 2026-03-02 | Warnings, Adverse reactions | 6490C9U457 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.