NDC 58198-0013 - T8 Keto Flush
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
- 58198-0013
- Package NDCs from labels
- 58198-0013-1, 58198-0013-2
- Manufacturer
- Elanco US Inc.
- Effective date
- 2025-10-28
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Elanco ™ T8 Keto™ FLUSH | Elanco US Inc. | 2025-10-28 | PRESCRIPTION ANIMAL DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58198-0013-1 | T8 Keto Flush | 1 in 1 BOTTLE, PLASTIC | SOLUTION | 1 | 3 | |
| 58198-0013-1 | T8 Keto Flush | 118 mL in 1 BOTTLE, PLASTIC | SOLUTION | 118 | 3 | |
| 58198-0013-2 | T8 Keto Flush | 1 in 1 BOTTLE, PLASTIC | SOLUTION | 1 | 3 | |
| 58198-0013-2 | T8 Keto Flush | 355 mL in 1 BOTTLE, PLASTIC | SOLUTION | 355 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 58198-0013 | T8 KETO FLUSH (KETOCONAZOLE) SOLUTION [ELANCO US INC.] | 2 | 4 package rows | 20230420_2fff06d2-c883-4d8a-af7a-958b5fe9746f.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 |
|---|---|---|---|---|---|---|
| Ketoconazole | KETOCONAZOLE | Bryant Ranch Prepack | dc635682-170d-46ad-a9ba-6a75c6e0950e | 2024-01-11 | Warnings, Adverse reactions | R9400W927I |
| Ketoconazole | KETOCONAZOLE | A-S Medication Solutions | b3b99c8b-4512-4972-935d-602d4b8325c4 | 2024-01-08 | Warnings, Adverse reactions | R9400W927I |
| Ketoconazole | KETOCONAZOLE | A-S Medication Solutions | 8ef1117d-0b63-4c26-beaa-7667b2387e14 | 2023-11-17 | Warnings, Adverse reactions | R9400W927I |
| KETOCONAZOLE | KETOCONAZOLE | A-S Medication Solutions | 517c29fc-2a2a-4bd5-a8bb-b464a65d2be0 | 2023-11-01 | Boxed warning, Warnings, Adverse reactions | R9400W927I |
| Ketoconazole | KETOCONAZOLE | A-S Medication Solutions | c29d4ddc-aa1c-41c6-99ce-9aff35d213f6 | 2023-09-25 | Adverse reactions | R9400W927I |
| KETOCONAZOLE | KETOCONAZOLE | Burel Pharmaceuticals, LLC | 57e81e13-b395-4dbd-b660-3038de41a838 | 2023-08-01 | Boxed warning, Warnings, Adverse reactions | R9400W927I |
| Ketoconazole | KETOCONAZOLE | Proficient Rx LP | cb1908da-443d-40b8-b8c7-b115bc2d37e0 | 2022-11-01 | Adverse reactions | R9400W927I |
| Ketoconazole | KETOCONAZOLE | Proficient Rx LP | 4f08caf2-a57c-4146-9289-532711bbdbcd | 2022-04-01 | Warnings, Adverse reactions | R9400W927I |
| Ketoconazole | KETOCONAZOLE | Teva Pharmaceuticals USA, Inc. | 7fc47a6a-3714-4598-ae3b-d5a229262c21 | 2021-09-02 | Warnings, Adverse reactions | R9400W927I |
| Ketoconazole | KETOCONAZOLE FOAM | Xiromed, LLC | ea319889-5e58-f778-3009-5ba6a5f2690a | 2019-09-23 | Warnings, Adverse reactions | R9400W927I |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.