XILAPAK

Product NDC
70350-5218
11-digit product format
703505218
Labeler code
70350
Product ID
70350-5218_1bdd2cf2-169b-4e44-a01b-122ee5661ae8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FLUOCINOLONE ACETONIDE
Dosage form
KIT
Labeler
SOLUTECH PHARMACEUTICALS LLC
Application
NDA015296
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2017-11-01
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
E
Listing certified through
2018-12-31
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
70350-5218-12020-01-31C16284748780-19d75b9d0-f313-f424-e053-dadaa90a57ceXILAPAK KIT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52565-012-59XILAPAK60 mL in 1 BOTTLE, WITH APPLICATORSOLUTION60 mL0.1 mg in 1mL1
52565-012-59XILAPAK1 in 1 CARTONSOLUTION0.1 mg in 1mL1
70350-5218-1XILAPAK1 in 1 CARTONKIT11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70350-5218-1EA - Each70350-52188e5d0513-a89c-4d47-b7af-ee920dd1b2c112017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70350-5218XILAPAK (FLUOCINOLONE ACETONIDE) KIT [SOLUTECH PHARMACEUTICALS LLC]1Legacy NDC, 3 package rows20171104_f1b8a26a-dc63-4701-8a78-cc1f99fca1b3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1191310fluocinolone acetonide 0.01 % Topical SolutionPSNf1b8a26a-dc63-4701-8a78-cc1f99fca1b31
1191310fluocinolone acetonide 0.1 MG/ML Topical SolutionSCDf1b8a26a-dc63-4701-8a78-cc1f99fca1b31
1191310fluocinolone acetonide 0.01 % Topical SolutionSYf1b8a26a-dc63-4701-8a78-cc1f99fca1b31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
52565-012-595256500125960 mL in 1 BOTTLE, WITH APPLICATOR60 mlHistorical
70350-5218-1703505218011 in 1 CARTONHistorical