NDC 24338-080-25 - OTOVEL
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
- 24338-080
- Requested NDC
- 24338-080-25
- Package NDCs from labels
- 24338-080-25, 24338-080-14
- Manufacturer
- Arbor Pharmaceuticals | Laboratorios Salvat | The Ritedose Corporation
- Effective date
- 2019-09-12
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| OTOVEL - Arbor Pharmaceuticals | Laboratorios Salvat | The Ritedose Corporation | Arbor Pharmaceuticals | Laboratorios Salvat | The Ritedose Corporation | 2019-09-12 | HUMAN PRESCRIPTION DRUG LABEL |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 24338-080-14 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-ec5a-a426-e053-dadaa90af4c2 | These highlights do not include all the information needed to use OTOVEL safely and effectively. See full prescribing information for OTOVEL. OTOVEL (ciprofloxacin and fluocinolone acetonide) otic solution Initial U.S. Approval: 2016 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 24338-080-14 | OTOVEL | 14 in 1 POUCH | SOLUTION | 14 | 3 | |
| 24338-080-14 | OTOVEL | 1 in 1 CARTON | SOLUTION | 1 | 3 | |
| 24338-080-25 | OTOVEL | 0.25 mL in 1 VIAL, SINGLE-DOSE | SOLUTION | 0.25 | 3 |
DailyMed Dashboard NDC Coverage#
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.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.