FDA.reportPublic FDA data

Flac Otic Oil

Product NDC
39328-079
11-digit product format
393280079
Labeler code
39328
Product ID
39328-079_b9a91a1b-2c51-4ef3-8152-7a720061b5aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluocinolone acetonide
Dosage form
OIL
Route
AURICULAR (OTIC)
Labeler
Patrin Pharma, Inc.
Application
ANDA210736
Marketing category
ANDA
Marketing start
2018-04-12
Substance
FLUOCINOLONE ACETONIDE
Active strength
.11 mg/mL
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Flac Otic Oil
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUOCINOLONE ACETONIDE.11 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0CD5FD6S2M
Rxcui1191299, 2045201

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0adb2af5-1ecf-4df5-912b-16ae89228294Product name620240829
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
65f6255d-41cc-425f-ba54-b1bea4947886Product name520210930
5ba208e4-886f-44da-e218-ab4f4cad2c49Product name520190612
e5a2793f-318b-72fd-b734-c44ecc6f6748Product name220190213
9e453f34-aacb-44d5-a119-c0e3dc1fca2aProduct name120160622
7df2570a-c555-4d82-9189-9247c722b62cProduct name120150402
85490a6b-2306-6bf2-c51b-eb63537dc2daProduct name120140508
a78a3633-fd06-b0af-63b3-c714de3b3bfaProduct name120140508
b2d0a9c2-fd0c-a9b4-ae41-f6a4eef4fbf6Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
39328-079-202024-11-19C16284748780-11030e365-28dc-111a-e063-dadaa90a10e2Flac ® Otic Oil (fluocinolone acetonide oil, 0.01%) Ear Drops
39328-079-202024-07-30C16284748780-11030e365-28dc-111a-e063-dadaa90a10e2Flac ® Otic Oil (fluocinolone acetonide oil, 0.01%) Ear Drops
39328-079-202024-01-30C16284748780-11030e365-28dc-111a-e063-dadaa90a10e2Flac ® Otic Oil (fluocinolone acetonide oil, 0.01%) Ear Drops

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
39328-079-20Flac Otic Oil20 mL in 1 BOTTLE, DROPPEROIL206
39328-079-20Flac Otic Oil1 in 1 CARTONOIL16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
39328-079-20ML - Milliliter39328-0792689b79e-3f5a-4d41-bec8-46a251050f6412018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
39328-079FLAC OTIC OIL (FLUOCINOLONE ACETONIDE) OIL [PATRIN PHARMA, INC.]6Current NDC, Legacy NDC, 2 package rows20241121_4b0a46b6-dcb7-4c4e-8b02-cf72eede3cbb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2045201Flac 0.01 % Otic SolutionPSN4b0a46b6-dcb7-4c4e-8b02-cf72eede3cbb6
1191299fluocinolone acetonide 0.01 % Oil for Otic SolutionPSN4b0a46b6-dcb7-4c4e-8b02-cf72eede3cbb6
2045201fluocinolone acetonide 0.1 MG/ML Otic Solution [Flac]SBD4b0a46b6-dcb7-4c4e-8b02-cf72eede3cbb6
1191299fluocinolone acetonide 0.1 MG/ML Otic SolutionSCD4b0a46b6-dcb7-4c4e-8b02-cf72eede3cbb6
2045201Flac 0.01 % Otic SolutionSY4b0a46b6-dcb7-4c4e-8b02-cf72eede3cbb6
2045201Flac 0.1 MG/ML Otic SolutionSY4b0a46b6-dcb7-4c4e-8b02-cf72eede3cbb6
1191299fluocinolone acetonide 0.01 % Auricular OilSY4b0a46b6-dcb7-4c4e-8b02-cf72eede3cbb6
1191299fluocinolone acetonide 0.01 % Oil for Otic SolutionSY4b0a46b6-dcb7-4c4e-8b02-cf72eede3cbb6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
39328-079-20393280079201 BOTTLE, DROPPER in 1 CARTON (39328-079-20) / 20 mL in 1 BOTTLE, DROPPER2018-04-120000-00-00NoNoCurrent