Flurandrenolide

Product NDC
45802-928
11-digit product format
458020928
Labeler code
45802
Product ID
45802-928_a5be325d-6006-40c1-bace-5adcf29548e5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Flurandrenolide
Dosage form
LOTION
Route
TOPICAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
ANDA207133
Marketing category
ANDA
Marketing start
2016-10-06
Substance
FLURANDRENOLIDE
Active strength
.5 mg/mL
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
Flurandrenolide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLURANDRENOLIDE.5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8EUL29XUQT
Rxcui197719

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b046c6cd-ed10-2b40-9e85-9cb60b50fa3fProduct name320170404
2ed24cee-55db-9e19-e6d2-8702f9ff1929Product name320170314
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45802-928-03Flurandrenolide120 mL in 1 BOTTLE, PLASTICLOTION1205

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-928-03ML - Milliliter45802-92888c23920-3ad2-44ee-ae8a-3d7ef09166a112016-11-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-928FLURANDRENOLIDE LOTION [PADAGIS ISRAEL PHARMACEUTICALS LTD]5Current NDC, Legacy NDC, 1 package rows20221027_9c4f5aea-2e08-400c-88f6-d9e3013afda7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197719flurandrenolide 0.05 % Topical LotionPSN3868377d-bee3-42f4-8c72-319e84e7d5bd104
197719flurandrenolide 0.5 MG/ML Topical LotionSCD3868377d-bee3-42f4-8c72-319e84e7d5bd104
197719flurandrenolide 0.05 % Topical LotionSY3868377d-bee3-42f4-8c72-319e84e7d5bd104
197719flurandrenolide 0.05 % Topical LotionPSN2718df54-7dc1-4ebc-8258-607bedcf5813100
197719flurandrenolide 0.5 MG/ML Topical LotionSCD2718df54-7dc1-4ebc-8258-607bedcf5813100
197719flurandrenolide 0.05 % Topical LotionSY2718df54-7dc1-4ebc-8258-607bedcf5813100
197719flurandrenolide 0.05 % Topical LotionPSN9c4f5aea-2e08-400c-88f6-d9e3013afda75
197719flurandrenolide 0.5 MG/ML Topical LotionSCD9c4f5aea-2e08-400c-88f6-d9e3013afda75
197719flurandrenolide 0.05 % Topical LotionSY9c4f5aea-2e08-400c-88f6-d9e3013afda75

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-928-0345802092803120 mL in 1 BOTTLE, PLASTIC (45802-928-03) 120 ml2016-10-060000-00-00NoNoCurrent