fluocinolone acetonide

Product NDC
10135-670
11-digit product format
101350670
Labeler code
10135
Product ID
10135-670_ec99ef8a-cac9-e684-e053-2995a90ab617
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluocinolone acetonide
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Marlex Pharmaceuticals Inc
Application
ANDA209596
Marketing category
ANDA
Marketing start
2019-02-01
Marketing end
0000-00-00
Substance
FLUOCINOLONE ACETONIDE
Active strength
0 mg/mL
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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0adb2af5-1ecf-4df5-912b-16ae89228294Product name620240829
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
10135-670-612024-01-30C16284748780-1ba0f9c33-24e8-a910-e053-dadaa90a0b85Fluocinolone Acetonide
10135-670-612021-03-15C16284748780-1ba0f9c33-24e8-a910-e053-dadaa90a0b85Fluocinolone Acetonide
10135-670-612021-01-29C16284748780-1ba0f9c33-24e8-a910-e053-dadaa90a0b85Fluocinolone Acetonide

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10135-670-61fluocinolone acetonide60 mL in 1 BOTTLE, WITH APPLICATORSOLUTION604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-670-61ML - Milliliter10135-670a7ee0f7f-642b-470a-9b00-9ea275f5d02b12019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-670FLUOCINOLONE ACETONIDE SOLUTION [MARLEX PHARMACEUTICALS INC]4Legacy NDC, 1 package rows20221104_7105ba2c-4159-465e-9f2d-6ebfd13fc8bd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1191310fluocinolone acetonide 0.01 % Topical SolutionPSN7105ba2c-4159-465e-9f2d-6ebfd13fc8bd4
1191310fluocinolone acetonide 0.1 MG/ML Topical SolutionSCD7105ba2c-4159-465e-9f2d-6ebfd13fc8bd4
1191310fluocinolone acetonide 0.01 % Topical SolutionSY7105ba2c-4159-465e-9f2d-6ebfd13fc8bd4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10135-670-611013506706160 mL in 1 BOTTLE, WITH APPLICATOR (10135-670-61) 60 ml2019-02-010000-00-00NoNoCurrent