Fluocinolone Acetonide

Product NDC
65162-702
11-digit product format
651620702
Labeler code
65162
Product ID
65162-702_6c17f07e-2066-4eb0-95f0-1f1b495b7862
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluocinolone Acetonide
Dosage form
OIL
Route
AURICULAR (OTIC)
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA091306
Marketing category
ANDA
Marketing start
2015-09-22
Marketing end
0000-00-00
Substance
FLUOCINOLONE ACETONIDE
Active strength
0 mg/20mL
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65162-702-942020-11-30C16284748780-19d75b9d0-4eb5-f424-e053-dadaa90a57cea48fba5c-815f-4d82-b8e0-20665abd7b26
65162-702-942020-01-31C16284748780-19d75b9d0-4eb5-f424-e053-dadaa90a57cea48fba5c-815f-4d82-b8e0-20665abd7b26

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-702-94ML - Milliliter65162-702e589a6f5-9789-440b-be24-eeb84cc0b34c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUOCINOLONE ACETONIDEACTIVE INGREDIENT0CD5FD6S2MFLUOCINOLONE ACETONIDE OIL [AMNEAL PHARMACEUTICALS, LLC]12
FLUOCINOLONE ACETONIDEACTIVE MOIETY0CD5FD6S2MFLUOCINOLONE ACETONIDE OIL [AMNEAL PHARMACEUTICALS, LLC]12
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302FLUOCINOLONE ACETONIDE OIL [AMNEAL PHARMACEUTICALS, LLC]12
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSFLUOCINOLONE ACETONIDE OIL [AMNEAL PHARMACEUTICALS, LLC]12
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVPFLUOCINOLONE ACETONIDE OIL [AMNEAL PHARMACEUTICALS, LLC]12
OLETH-2INACTIVE INGREDIENT7L6R1SQ6M0FLUOCINOLONE ACETONIDE OIL [AMNEAL PHARMACEUTICALS, LLC]12
PEANUT OILINACTIVE INGREDIENT5TL50QU0W4FLUOCINOLONE ACETONIDE OIL [AMNEAL PHARMACEUTICALS, LLC]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-702FLUOCINOLONE ACETONIDE OIL [AMNEAL PHARMACEUTICALS LLC]18Legacy NDC20250523_a48fba5c-815f-4d82-b8e0-20665abd7b26.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65162-702-94651620702941 BOTTLE in 1 CARTON (65162-702-94) > 20 mL in 1 BOTTLE1 bottle2015-09-220000-00-00NoNoCurrent