FDA.reportPublic FDA data

NOXIPAK

Product NDC
70350-5201
11-digit product format
703505201
Labeler code
70350
Product ID
70350-5201_e8816c67-a9d7-4953-99e5-c2095aa10713
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FLUOCINOLONE ACETONIDE and UREA
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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
65f6255d-41cc-425f-ba54-b1bea4947886Product name520210930
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
5ba208e4-886f-44da-e218-ab4f4cad2c49Product name520190612
e5a2793f-318b-72fd-b734-c44ecc6f6748Product name220190213
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
9e453f34-aacb-44d5-a119-c0e3dc1fca2aProduct name120160622
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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
70350-5201-12020-01-31C16284748780-19d75b9d0-42a0-f424-e053-dadaa90a57ceNOXIPAK KIT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52565-012-59NOXIPAK1 in 1 CARTONSOLUTION0.1 mg in 1mL2
52565-012-59NOXIPAK60 mL in 1 BOTTLE, WITH APPLICATORSOLUTION60 mL0.1 mg in 1mL2
58980-610-30NOXIPAK85 g in 1 TUBECREAM85 g17 g in 85g2
58980-610-30NOXIPAK1 in 1 BOXCREAM17 g in 85g2
70350-5201-1NOXIPAK1 in 1 CARTONKIT12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70350-5201-1EA - Each70350-52012e4efcb7-1fdf-4771-8e82-c8615714d1bc12017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70350-5201NOXIPAK (FLUOCINOLONE ACETONIDE AND UREA) KIT [SOLUTECH PHARMACEUTICALS LLC]2Legacy NDC, 5 package rows20171109_136cb37e-e939-40b5-9725-194b14a9b090.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1191310fluocinolone acetonide 0.01 % Topical SolutionPSN136cb37e-e939-40b5-9725-194b14a9b0902
198886urea 20 % Topical CreamPSN136cb37e-e939-40b5-9725-194b14a9b0902
1191310fluocinolone acetonide 0.1 MG/ML Topical SolutionSCD136cb37e-e939-40b5-9725-194b14a9b0902
198886urea 200 MG/ML Topical CreamSCD136cb37e-e939-40b5-9725-194b14a9b0902
1191310fluocinolone acetonide 0.01 % Topical SolutionSY136cb37e-e939-40b5-9725-194b14a9b0902
198886urea 17 GM in 85 GM Topical CreamSY136cb37e-e939-40b5-9725-194b14a9b0902
198886urea 20 % Topical CreamSY136cb37e-e939-40b5-9725-194b14a9b0902

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
52565-012-59525650012591 in 1 CARTONHistorical
58980-610-305898006103085 g in 1 TUBE85 gHistorical
70350-5201-1703505201011 in 1 CARTONHistorical