Flurandrenolide

Product NDC
63629-8657
11-digit product format
636298657
Labeler code
63629
Product ID
63629-8657_00b804f5-7685-0b1d-e063-6294a90a5753
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Flurandrenolide
Dosage form
LOTION
Route
TOPICAL
Labeler
Bryant Ranch Prepack
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
63629-8657-1Flurandrenolide120 mL in 1 BOTTLE, PLASTICLOTION120104
63629-8657-1Flurandrenolide1 in 1 CARTONLOTION1104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8657-1ML - Milliliter63629-86573eacdbcb-57ba-4920-ada6-34376942aa8c12023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8657FLURANDRENOLIDE LOTION [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 2 package rows20230718_3868377d-bee3-42f4-8c72-319e84e7d5bd.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-8657-1636298657011 BOTTLE, PLASTIC in 1 CARTON (63629-8657-1) / 120 mL in 1 BOTTLE, PLASTIC2016-10-060000-00-00NoNoCurrent