FDA.reportPublic FDA data

OTOVEL

Product NDC
66992-128
11-digit product format
669920128
Labeler code
66992
Product ID
66992-128_1f604776-2e24-4326-8c16-9850737b105a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ciprofloxacin and fluocinolone acetonide
Dosage form
SOLUTION
Route
AURICULAR (OTIC)
Labeler
WraSer LLC
Application
NDA208251
Marketing category
NDA
Marketing start
2021-10-04
Marketing end
0000-00-00
Substance
CIPROFLOXACIN; FLUOCINOLONE ACETONIDE
Active strength
1 mg/.25mL; mg/.25mL
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Quinolone Antimicrobial [EPC], Quinolones [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0adb2af5-1ecf-4df5-912b-16ae89228294Product name620240829
ea50b939-d92a-4100-84f5-1c1089663837Product name220240705
65f6255d-41cc-425f-ba54-b1bea4947886Product name520210930
5ba208e4-886f-44da-e218-ab4f4cad2c49Product name520190612
e5a2793f-318b-72fd-b734-c44ecc6f6748Product name220190213
90aab9f8-63f3-478d-8db8-951525a18ab1Product name120180814
200e1d3d-46da-4371-beed-747da3cb3ff8Product name120180702
9e453f34-aacb-44d5-a119-c0e3dc1fca2aProduct name120160622
01eecbfe-0b50-413b-8898-6905c89b6568Product name120151228
7df2570a-c555-4d82-9189-9247c722b62cProduct name120150402
85490a6b-2306-6bf2-c51b-eb63537dc2daProduct name120140508
a3304bb6-ef4e-06df-d604-35f7e883ed6cProduct name120140508
a78a3633-fd06-b0af-63b3-c714de3b3bfaProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
b2d0a9c2-fd0c-a9b4-ae41-f6a4eef4fbf6Product name120140508
de5ea793-ffd9-0308-b0ca-00d9967be4eeProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66992-128-142024-04-21C16284748780-11030e365-590d-111a-e063-dadaa90a10e2These 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
66992-128-142024-01-30C16284748780-11030e365-590d-111a-e063-dadaa90a10e2These 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 table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66992-128-14OTOVEL14 in 1 POUCHSOLUTION145
66992-128-14OTOVEL1 in 1 CARTONSOLUTION15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66992-128-14EA - Each66992-1287b0b1fa9-610e-4eec-9432-4c490995537312021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66992-128OTOVEL (CIPROFLOXACIN AND FLUOCINOLONE ACETONIDE) SOLUTION [WRASER LLC]5Legacy NDC, 2 package rows20241011_dc17b816-b97f-4c44-9f05-b41f76ab3a52.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1792386ciprofloxacin 0.3 % / fluocinolone acetonide 0.025 % Otic SolutionPSNdc17b816-b97f-4c44-9f05-b41f76ab3a525
1792391Otovel 0.3 % / 0.025 % Otic SolutionPSNdc17b816-b97f-4c44-9f05-b41f76ab3a525
1792391ciprofloxacin 3 MG/ML / fluocinolone acetonide 0.25 MG/ML Otic Solution [Otovel]SBDdc17b816-b97f-4c44-9f05-b41f76ab3a525
1792386ciprofloxacin 3 MG/ML / fluocinolone acetonide 0.25 MG/ML Otic SolutionSCDdc17b816-b97f-4c44-9f05-b41f76ab3a525
1792386ciprofloxacin 0.3 % / fluocinolone acetonide 0.025 % Otic SolutionSYdc17b816-b97f-4c44-9f05-b41f76ab3a525
1792391Otovel (ciprofloxacin 0.3 % / fluocinolone acetonide 0.025 % ) Otic SolutionSYdc17b816-b97f-4c44-9f05-b41f76ab3a525

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66992-128-14669920128141 POUCH in 1 CARTON (66992-128-14) > 14 VIAL, SINGLE-DOSE in 1 POUCH > .25 mL in 1 VIAL, SINGLE-DOSE1 pouch2021-10-040000-00-00NoNoCurrent