FDA.reportPublic FDA data

Diflorasone Diacetate

Product NDC
64980-124
11-digit product format
649800124
Labeler code
64980
Product ID
64980-124_0cc31fd1-b6fb-44d0-a911-b4c11ce12c4b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diflorasone diacetate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA207440
Marketing category
ANDA
Marketing start
2017-02-27
Substance
DIFLORASONE DIACETATE
Active strength
.5 mg/g
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
Diflorasone Diacetate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIFLORASONE DIACETATE.5 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7W2J09SCWX
Rxcui966607

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64980-124-03Diflorasone Diacetate30 g in 1 TUBEOINTMENT304
64980-124-03Diflorasone Diacetate1 in 1 CARTONOINTMENT14
64980-124-15Diflorasone Diacetate15 g in 1 TUBEOINTMENT154
64980-124-15Diflorasone Diacetate1 in 1 CARTONOINTMENT14
64980-124-45Diflorasone Diacetate45 g in 1 TUBEOINTMENT454
64980-124-45Diflorasone Diacetate1 in 1 CARTONOINTMENT14
64980-124-60Diflorasone Diacetate1 in 1 CARTONOINTMENT14
64980-124-60Diflorasone Diacetate60 g in 1 TUBEOINTMENT604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64980-124-03GM - Gram64980-12476b3539e-676f-4d91-bbab-d72827719fcf12020-08-06
64980-124-15GM - Gram64980-124f534fa53-ff89-402d-b3e0-3b92baa05c8712020-08-06
64980-124-45GM - Gram64980-124a3355e02-efc6-4fd3-b788-60661d15b8d412021-09-07
64980-124-60GM - Gram64980-12486b4e95f-a177-48a3-a6fd-f9352bd3d62012020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64980-124DIFLORASONE DIACETATE OINTMENT [RISING PHARMA HOLDINGS, INC.]4Current NDC, Legacy NDC, 8 package rows20230625_23eb27a4-157f-4eb5-a390-37586710808f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
966607diflorasone diacetate 0.05 % Topical OintmentPSN23eb27a4-157f-4eb5-a390-37586710808f4
966607diflorasone diacetate 0.0005 MG/MG Topical OintmentSCD23eb27a4-157f-4eb5-a390-37586710808f4
966607diflorasone diacetate 0.05 % Topical OintmentSY23eb27a4-157f-4eb5-a390-37586710808f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64980-124-03649800124031 TUBE in 1 CARTON (64980-124-03) / 30 g in 1 TUBE1 tube2017-02-270000-00-00NoNoCurrent
64980-124-15649800124151 TUBE in 1 CARTON (64980-124-15) / 15 g in 1 TUBE1 tube2017-02-270000-00-00NoNoCurrent
64980-124-45649800124451 TUBE in 1 CARTON (64980-124-45) / 45 g in 1 TUBE1 tube2017-02-270000-00-00NoNoCurrent
64980-124-60649800124601 TUBE in 1 CARTON (64980-124-60) / 60 g in 1 TUBE1 tube2017-02-270000-00-00NoNoCurrent