FDA.reportPublic FDA data

Diflorasone Diacetate

Product NDC
51672-1295
11-digit product format
516721295
Labeler code
51672
Product ID
51672-1295_39095d21-70bb-6f1d-e063-6394a90a9b9d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diflorasone Diacetate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA075331
Marketing category
ANDA
Marketing start
1999-05-14
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
51672-1295-1Diflorasone Diacetate1 in 1 CARTONOINTMENT16
51672-1295-1Diflorasone Diacetate15 g in 1 TUBEOINTMENT156
51672-1295-2Diflorasone Diacetate30 g in 1 TUBEOINTMENT306
51672-1295-2Diflorasone Diacetate1 in 1 CARTONOINTMENT16
51672-1295-3Diflorasone Diacetate60 g in 1 TUBEOINTMENT606
51672-1295-3Diflorasone Diacetate1 in 1 CARTONOINTMENT16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1295-1GM - Gram51672-1295f6b2184f-d8d3-4fbc-8efe-bc66393ae60712012-07-24
51672-1295-2GM - Gram51672-1295829822dc-1bdc-4892-b38e-0332fb58467512012-07-24
51672-1295-3GM - Gram51672-12959a49a1f6-95ef-4c70-91d7-28d08f4b342012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Diflorasone DiacetateACTIVE INGREDIENT7W2J09SCWXDIFLORASONE DIACETATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]3
DiflorasoneACTIVE MOIETYT2DHJ9645WDIFLORASONE DIACETATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]3
glyceryl monostearateINACTIVE INGREDIENT230OU9XXE4DIFLORASONE DIACETATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]3
petrolatumINACTIVE INGREDIENT4T6H12BN9UDIFLORASONE DIACETATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]3
propylene glycolINACTIVE INGREDIENT6DC9Q167V3DIFLORASONE DIACETATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1295DIFLORASONE DIACETATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]5Current NDC, Legacy NDC, 6 package rows20241222_b304dfca-e840-4c03-8217-73aaa5360277.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
966607diflorasone diacetate 0.05 % Topical OintmentPSNb304dfca-e840-4c03-8217-73aaa53602776
966607diflorasone diacetate 0.0005 MG/MG Topical OintmentSCDb304dfca-e840-4c03-8217-73aaa53602776
966607diflorasone diacetate 0.05 % Topical OintmentSYb304dfca-e840-4c03-8217-73aaa53602776

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-1295-1516721295011 TUBE in 1 CARTON (51672-1295-1) / 15 g in 1 TUBE1 tube1999-05-140000-00-00NoNoCurrent
51672-1295-2516721295021 TUBE in 1 CARTON (51672-1295-2) / 30 g in 1 TUBE1 tube1999-05-140000-00-00NoNoCurrent
51672-1295-3516721295031 TUBE in 1 CARTON (51672-1295-3) / 60 g in 1 TUBE1 tube1999-05-140000-00-00NoNoCurrent