Fluocinolone acetonide 0.01%

Product NDC
13925-508
11-digit product format
139250508
Labeler code
13925
Product ID
13925-508_dfb898fc-1e28-4c46-ab2e-16139107ac4f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluocinolone acetonide
Dosage form
OIL
Route
AURICULAR (OTIC)
Labeler
Seton Pharmaceuticals
Application
NDA019452
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2013-08-01
Marketing end
0000-00-00
Substance
FLUOCINOLONE ACETONIDE
Active strength
0 mg/mL
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
13925-508-202024-01-30C16284748780-19d75b9d0-259f-f424-e053-dadaa90a57cebe70a464-f936-4721-8cbb-b106075bfd4d
13925-508-202020-01-31C16284748780-19d75b9d0-259f-f424-e053-dadaa90a57cebe70a464-f936-4721-8cbb-b106075bfd4d