psorcon

Product NDC
51672-5292
11-digit product format
516725292
Labeler code
51672
Product ID
51672-5292_38f8aa09-3cda-ae9a-e063-6294a90aa2f6
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
2014-08-01
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
psorcon
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIFLORASONE DIACETATE5 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7W2J09SCWX

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
51672-5292-3psorcon1 in 1 CARTONCREAM14
51672-5292-3psorcon60 g in 1 TUBECREAM604
51672-5292-5psorcon1 in 1 CARTONCREAM14
51672-5292-5psorcon5 g in 1 TUBECREAM54

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-5292-3GM - Gram51672-5292b6634e51-6cc7-421d-81f3-cfc6d619940b12015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Diflorasone DiacetateACTIVE INGREDIENT7W2J09SCWXPSORCON (DIFLORASONE DIACETATE) CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
DiflorasoneACTIVE MOIETYT2DHJ9645WPSORCON (DIFLORASONE DIACETATE) CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
butylated hydroxytolueneINACTIVE INGREDIENT1P9D0Z171KPSORCON (DIFLORASONE DIACETATE) CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
cetyl alcoholINACTIVE INGREDIENT936JST6JCNPSORCON (DIFLORASONE DIACETATE) CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPPSORCON (DIFLORASONE DIACETATE) CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
glyceryl monostearateINACTIVE INGREDIENT230OU9XXE4PSORCON (DIFLORASONE DIACETATE) CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
isopropyl myristateINACTIVE INGREDIENT0RE8K4LNJSPSORCON (DIFLORASONE DIACETATE) CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
lanolin alcoholsINACTIVE INGREDIENT884C3FA9HEPSORCON (DIFLORASONE DIACETATE) CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
mineral oilINACTIVE INGREDIENTT5L8T28FGPPSORCON (DIFLORASONE DIACETATE) CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
PEG-100 stearateINACTIVE INGREDIENTYD01N1999RPSORCON (DIFLORASONE DIACETATE) CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
polyoxyl 40 stearateINACTIVE INGREDIENT13A4J4NH9IPSORCON (DIFLORASONE DIACETATE) CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
polysorbate 60INACTIVE INGREDIENTCAL22UVI4MPSORCON (DIFLORASONE DIACETATE) CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
propylene glycolINACTIVE INGREDIENT6DC9Q167V3PSORCON (DIFLORASONE DIACETATE) CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
sodium phosphate, monobasicINACTIVE INGREDIENT3980JIH2SWPSORCON (DIFLORASONE DIACETATE) CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
sorbitan monostearateINACTIVE INGREDIENTNVZ4I0H58XPSORCON (DIFLORASONE DIACETATE) CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
waterINACTIVE INGREDIENT059QF0KO0RPSORCON (DIFLORASONE DIACETATE) CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-5292PSORCON (DIFLORASONE DIACETATE) CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3Current NDC, Legacy NDC, 4 package rows20180710_de40cc65-f955-423f-9cbd-bc2245c4f982.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-5292-3516725292031 TUBE in 1 CARTON (51672-5292-3) / 60 g in 1 TUBE1 tube2014-08-010000-00-00NoNoCurrent
51672-5292-5516725292051 TUBE in 1 CARTON (51672-5292-5) / 5 g in 1 TUBE1 tube2014-08-010000-00-00NoNoCurrent