FDA.reportPublic FDA data

CORDRAN

Product NDC
16110-587
11-digit product format
161100587
Labeler code
16110
Product ID
16110-587_8af8ee07-49b6-4051-94bb-71f123e69b8b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
flurandrenolide
Dosage form
TAPE
Route
TOPICAL
Labeler
Almirall, LLC
Application
NDA016455
Marketing category
NDA
Marketing start
2018-09-24
Substance
FLURANDRENOLIDE
Active strength
4 ug/cm2
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CORDRAN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLURANDRENOLIDE4 ug/cm2

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8EUL29XUQT
Rxcui797694, 797697

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b046c6cd-ed10-2b40-9e85-9cb60b50fa3fProduct name320170404
2ed24cee-55db-9e19-e6d2-8702f9ff1929Product name320170314

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16110-587-24CORDRAN450 cm2 in 1 BottleTAPE4505
16110-587-24CORDRAN1 in 1 CartonTAPE15
16110-587-80CORDRAN1 in 1 CartonTAPE15
16110-587-80CORDRAN1500 cm2 in 1 BottleTAPE15005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16110-587-80EA - Each16110-5872c396ca5-f88d-4f1a-8c35-a757559337b412020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16110-587CORDRAN (FLURANDRENOLIDE) TAPE [ALMIRALL, LLC]4Current NDC, Legacy NDC, 4 package rows20231114_837a7b23-ab14-4f23-873d-bdee95177691.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
797697Cordran 0.004 MG/SQCM Medicated TapePSN837a7b23-ab14-4f23-873d-bdee951776915
797694flurandrenolide 0.004 MG/SQCM Medicated TapePSN837a7b23-ab14-4f23-873d-bdee951776915
797697flurandrenolide 0.004 MG/SQCM Medicated Tape [Cordran]SBD837a7b23-ab14-4f23-873d-bdee951776915
797694flurandrenolide 0.004 MG/SQCM Medicated TapeSCD837a7b23-ab14-4f23-873d-bdee951776915
797697Cordran 0.004 MG/SQCM Medicated TapeSY837a7b23-ab14-4f23-873d-bdee951776915
797697Cordran 4 MCG/SQCM Medicated TapeSY837a7b23-ab14-4f23-873d-bdee951776915

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16110-587-24161100587241 BOTTLE in 1 CARTON (16110-587-24) / 450 cm2 in 1 BOTTLE1 bottle2019-09-100000-00-00NoNoCurrent
16110-587-80161100587801 BOTTLE in 1 CARTON (16110-587-80) / 1500 cm2 in 1 BOTTLE1 bottle2019-09-100000-00-00NoNoCurrent