FDA.reportPublic FDA data

Flurandrenolide

Product NDC
52565-017
11-digit product format
525650017
Labeler code
52565
Product ID
52565-017_25bacae9-c26d-40d7-8844-66d947ce58d6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Flurandrenolide
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Teligent Pharma, Inc.
Application
ANDA207851
Marketing category
ANDA
Marketing start
2016-12-30
Marketing end
0000-00-00
Substance
FLURANDRENOLIDE
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
b046c6cd-ed10-2b40-9e85-9cb60b50fa3fProduct name320170404
2ed24cee-55db-9e19-e6d2-8702f9ff1929Product name320170314

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52565-017-152023-01-30C16284748780-1f386c649-a086-0266-e053-dadaa90a7c1aFLURANDRENOLIDE OINTMENT USP, 0.05%
52565-017-302023-01-30C16284748780-1f386c649-a086-0266-e053-dadaa90a7c1aFLURANDRENOLIDE OINTMENT USP, 0.05%
52565-017-602023-01-30C16284748780-1f386c649-a086-0266-e053-dadaa90a7c1aFLURANDRENOLIDE OINTMENT USP, 0.05%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52565-017-15Flurandrenolide1 in 1 CARTONOINTMENT12
52565-017-15Flurandrenolide15 g in 1 TUBEOINTMENT152
52565-017-30Flurandrenolide30 g in 1 TUBEOINTMENT302
52565-017-30Flurandrenolide1 in 1 CARTONOINTMENT12
52565-017-60Flurandrenolide1 in 1 CARTONOINTMENT12
52565-017-60Flurandrenolide60 g in 1 TUBEOINTMENT602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52565-017-60GM - Gram52565-017939a1712-09ca-4f32-bae1-6ec62f9458e512017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52565-017FLURANDRENOLIDE (FLURANDRENOLIDE) OINTMENT [TELIGENT PHARMA, INC.]2Legacy NDC, 6 package rows20190911_14709d5d-186c-41f1-a7cc-e08872ad6e28.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197720flurandrenolide 0.05 % Topical OintmentPSN14709d5d-186c-41f1-a7cc-e08872ad6e282
197720flurandrenolide 0.0005 MG/MG Topical OintmentSCD14709d5d-186c-41f1-a7cc-e08872ad6e282
197720flurandrenolide 0.05 % Topical OintmentSY14709d5d-186c-41f1-a7cc-e08872ad6e282

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52565-017-15525650017151 TUBE in 1 CARTON (52565-017-15) > 15 g in 1 TUBE1 tube2016-12-300000-00-00NoNoCurrent
52565-017-30525650017301 TUBE in 1 CARTON (52565-017-30) > 30 g in 1 TUBE1 tube2016-12-300000-00-00NoNoCurrent
52565-017-60525650017601 TUBE in 1 CARTON (52565-017-60) > 60 g in 1 TUBE1 tube2016-12-300000-00-00NoNoCurrent