FDA.reportPublic FDA data

Diflorasone Diacetate

Product NDC
52565-063
11-digit product format
525650063
Labeler code
52565
Product ID
52565-063_c382e0bf-1288-48f2-98f4-9b5a2b69d806
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diflorasone Diacetate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Teligent Pharma, Inc.
Application
ANDA210753
Marketing category
ANDA
Marketing start
2018-06-13
Marketing end
0000-00-00
Substance
DIFLORASONE DIACETATE
Active strength
1 mg/g
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a736ddb0-c60c-2985-b212-9ea950f1b2e1Product name420180807
76e36b5e-82fa-fc6e-0ec8-6f5912892c6aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52565-063-152023-01-30C16284748780-1f386c649-d502-0266-e053-dadaa90a7c1aDiflorasone Diacetate Ointment USP, 0.05%
52565-063-302023-01-30C16284748780-1f386c649-d502-0266-e053-dadaa90a7c1aDiflorasone Diacetate Ointment USP, 0.05%
52565-063-602023-01-30C16284748780-1f386c649-d502-0266-e053-dadaa90a7c1aDiflorasone Diacetate Ointment USP, 0.05%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52565-063-15Diflorasone Diacetate15 g in 1 TUBEOINTMENT152
52565-063-15Diflorasone Diacetate1 in 1 CARTONOINTMENT12
52565-063-30Diflorasone Diacetate30 g in 1 TUBEOINTMENT302
52565-063-30Diflorasone Diacetate1 in 1 CARTONOINTMENT12
52565-063-60Diflorasone Diacetate60 g in 1 TUBEOINTMENT602
52565-063-60Diflorasone Diacetate1 in 1 CARTONOINTMENT12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52565-063-15GM - Gram52565-0635cd91637-d447-4ed7-9b41-a445c9d02ada12018-09-05
52565-063-30GM - Gram52565-0637c0934e8-dc4e-469f-905d-e0bd5be78a6512018-09-05
52565-063-60GM - Gram52565-06359f2dec7-81b5-46f6-89b6-81e4afd86d2812018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52565-063DIFLORASONE DIACETATE OINTMENT [TELIGENT PHARMA, INC.]2Legacy NDC, 6 package rows20190911_20b7f7d9-bf45-4533-8173-6f1650388c66.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
966607diflorasone diacetate 0.05 % Topical OintmentPSN20b7f7d9-bf45-4533-8173-6f1650388c662
966607diflorasone diacetate 0.0005 MG/MG Topical OintmentSCD20b7f7d9-bf45-4533-8173-6f1650388c662
966607diflorasone diacetate 0.05 % Topical OintmentSY20b7f7d9-bf45-4533-8173-6f1650388c662

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52565-063-15525650063151 TUBE in 1 CARTON (52565-063-15) > 15 g in 1 TUBE1 tube2018-06-130000-00-00NoNoCurrent
52565-063-30525650063301 TUBE in 1 CARTON (52565-063-30) > 30 g in 1 TUBE1 tube2018-06-130000-00-00NoNoCurrent
52565-063-60525650063601 TUBE in 1 CARTON (52565-063-60) > 60 g in 1 TUBE1 tube2018-06-130000-00-00NoNoCurrent