Diflorasone Diacetate

Product NDC
51672-1296
11-digit product format
516721296
Labeler code
51672
Product ID
51672-1296_3f67ee08-7f98-f7af-e063-6294a90ae66c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diflorasone Diacetate
Dosage form
CREAM
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA075508
Marketing category
ANDA
Marketing start
2000-04-24
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
Rxcui966577

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
a736ddb0-c60c-2985-b212-9ea950f1b2e1Product name420180807
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
76e36b5e-82fa-fc6e-0ec8-6f5912892c6aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-1296-1Diflorasone Diacetate1 in 1 CARTONCREAM17
51672-1296-1Diflorasone Diacetate15 g in 1 TUBECREAM157
51672-1296-2Diflorasone Diacetate1 in 1 CARTONCREAM17
51672-1296-2Diflorasone Diacetate30 g in 1 TUBECREAM307
51672-1296-3Diflorasone Diacetate1 in 1 CARTONCREAM17
51672-1296-3Diflorasone Diacetate60 g in 1 TUBECREAM607

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1296-1GM - Gram51672-1296be25f218-bda1-452f-b82d-bf265e242d0812012-07-24
51672-1296-2GM - Gram51672-12968b259e2d-1e86-4472-8fbc-2d330df825ff12012-07-24
51672-1296-3GM - Gram51672-1296e4177e6d-ccb6-4d9d-bd2b-35da77c86c3e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Diflorasone DiacetateACTIVE INGREDIENT7W2J09SCWXDIFLORASONE DIACETATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
DiflorasoneACTIVE MOIETYT2DHJ9645WDIFLORASONE DIACETATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
butylated hydroxytolueneINACTIVE INGREDIENT1P9D0Z171KDIFLORASONE DIACETATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
cetyl alcoholINACTIVE INGREDIENT936JST6JCNDIFLORASONE DIACETATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPDIFLORASONE DIACETATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
glyceryl monostearateINACTIVE INGREDIENT230OU9XXE4DIFLORASONE DIACETATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
isopropyl myristateINACTIVE INGREDIENT0RE8K4LNJSDIFLORASONE DIACETATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
lanolin alcoholsINACTIVE INGREDIENT884C3FA9HEDIFLORASONE DIACETATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
mineral oilINACTIVE INGREDIENTT5L8T28FGPDIFLORASONE DIACETATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
palm oilINACTIVE INGREDIENT5QUO05548ZDIFLORASONE DIACETATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
peg-100 stearateINACTIVE INGREDIENTYD01N1999RDIFLORASONE DIACETATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
polyoxyl 40 stearateINACTIVE INGREDIENT13A4J4NH9IDIFLORASONE DIACETATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
polysorbate 60INACTIVE INGREDIENTCAL22UVI4MDIFLORASONE DIACETATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
propylene glycolINACTIVE INGREDIENT6DC9Q167V3DIFLORASONE DIACETATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
sodium phosphate, monobasicINACTIVE INGREDIENT3980JIH2SWDIFLORASONE DIACETATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
sorbitan monostearateINACTIVE INGREDIENTNVZ4I0H58XDIFLORASONE DIACETATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
soybean oilINACTIVE INGREDIENT241ATL177ADIFLORASONE DIACETATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
waterINACTIVE INGREDIENT059QF0KO0RDIFLORASONE DIACETATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1296DIFLORASONE DIACETATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]5Current NDC, Legacy NDC, 6 package rows20240616_b20c9420-8fb4-4a49-93f0-c0e4074d6d71.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
966577diflorasone diacetate 0.05 % Topical CreamPSNb20c9420-8fb4-4a49-93f0-c0e4074d6d717
966577diflorasone diacetate 0.5 MG/ML Topical CreamSCDb20c9420-8fb4-4a49-93f0-c0e4074d6d717
966577diflorasone diacetate 0.05 % Topical CreamSYb20c9420-8fb4-4a49-93f0-c0e4074d6d717

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-1296-1516721296011 TUBE in 1 CARTON (51672-1296-1) / 15 g in 1 TUBE1 tube2000-04-240000-00-00NoNoCurrent
51672-1296-2516721296021 TUBE in 1 CARTON (51672-1296-2) / 30 g in 1 TUBE1 tube2000-04-240000-00-00NoNoCurrent
51672-1296-3516721296031 TUBE in 1 CARTON (51672-1296-3) / 60 g in 1 TUBE1 tube2000-04-240000-00-00NoNoCurrent