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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075508-001DIFLORASONE DIACETATEDIFLORASONE DIACETATE0.05%CREAM / TOPICALBXRS2000-04-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A075508-001BX

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A075508-001DIFLORASONE DIACETATE0.05%CREAM / TOPICALBXRS2000-04-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075508-001DIFLORASONE DIACETATE0.05%CREAM / TOPICALBXRS2000-04-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075508-001DIFLORASONE DIACETATE0.05%CREAM / TOPICALBXRS2000-04-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A075508-001DIFLORASONE DIACETATE0.05%CREAM / TOPICALBXRS2000-04-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075508-001DIFLORASONE DIACETATE0.05%CREAM / TOPICALBXRS2000-04-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075508-001DIFLORASONE DIACETATE0.05%CREAM / TOPICALBXRS2000-04-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075508-001DIFLORASONE DIACETATE0.05%CREAM / TOPICALBXRS2000-04-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075508-001DIFLORASONE DIACETATE0.05%CREAM / TOPICALBXRS2000-04-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075508-001DIFLORASONE DIACETATE0.05%CREAM / TOPICALBXRS2000-04-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075508-001DIFLORASONE DIACETATE0.05%CREAM / TOPICALBXRS2000-04-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075508-001DIFLORASONE DIACETATE0.05%CREAM / TOPICALBXRS2000-04-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075508-001DIFLORASONE DIACETATE0.05%CREAM / TOPICALBXRS2000-04-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075508-001DIFLORASONE DIACETATE0.05%CREAM / TOPICALBXRS2000-04-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075508-001DIFLORASONE DIACETATE0.05%CREAM / TOPICALBXRS2000-04-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075508-001DIFLORASONE DIACETATE0.05%CREAM / TOPICALBXRS2000-04-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075508-001DIFLORASONE DIACETATE0.05%CREAM / TOPICALBXRS2000-04-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075508-001DIFLORASONE DIACETATE0.05%CREAM / TOPICALBXRS2000-04-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075508-001DIFLORASONE DIACETATE0.05%CREAM / TOPICALBXRS2000-04-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075508-001DIFLORASONE DIACETATE0.05%CREAM / TOPICALBXRS2000-04-2474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075508-001DIFLORASONE DIACETATE0.05%CREAM / TOPICALBXRS2000-04-24bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075508-001DIFLORASONE DIACETATE0.05%CREAM / TOPICALBXRS2000-04-24782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075508-001DIFLORASONE DIACETATE0.05%CREAM / TOPICALBXRS2000-04-2487673890dc5c…
2021-03-12 10:30 UTC2021-03A075508-001DIFLORASONE DIACETATE0.05%CREAM / TOPICALBXRS2000-04-245aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075508-001DIFLORASONE DIACETATE0.05%CREAM / TOPICALBXRS2000-04-248869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075508-001DIFLORASONE DIACETATE0.05%CREAM / TOPICALBXRS2000-04-24c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075508-001DIFLORASONE DIACETATE0.05%CREAM / TOPICALBXRS2000-04-243f01610625f2…
2019-09-15 20:21 UTC2019-09A075508-001DIFLORASONE DIACETATE0.05%CREAM / TOPICALBXRS2000-04-24b00525d2431f…
2019-07-19 19:46 UTC2019-07A075508-001DIFLORASONE DIACETATE0.05%CREAM / TOPICALBXRS2000-04-24ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075508-001DIFLORASONE DIACETATE0.05%CREAM / TOPICALBXRS2000-04-246a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075508-001DIFLORASONE DIACETATE0.05%CREAM / TOPICALBXRS2000-04-241c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075508-001DIFLORASONE DIACETATE0.05%CREAM / TOPICALBXRS2000-04-24ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075508-001DIFLORASONE DIACETATE0.05%CREAM / TOPICALBXRS2000-04-24a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075508-001DIFLORASONE DIACETATE0.05%CREAM / TOPICALBXRS2000-04-249b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075508-001DIFLORASONE DIACETATE0.05%CREAM / TOPICALBXRS2000-04-24a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075508-001DIFLORASONE DIACETATE0.05%CREAM / TOPICALBXRS2000-04-243f0d92c62455…
2023-05-13 08:27 UTC2023-05A075508-001DIFLORASONE DIACETATE0.05%CREAM / TOPICALBXRS2000-04-24053a50430f4f…
2023-01-26 05:58 UTC2023-01A075508-001DIFLORASONE DIACETATE0.05%CREAM / TOPICALBXRS2000-04-243bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075508-001DIFLORASONE DIACETATE0.05%CREAM / TOPICALBXRS2000-04-243a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075508-001DIFLORASONE DIACETATE0.05%CREAM / TOPICALBXRS2000-04-24f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075508-001DIFLORASONE DIACETATE0.05%CREAM / TOPICALBXRS2000-04-24e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A075508-001BX1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075508-001BX1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075508-001BX131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075508-001BX16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075508-001BX1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075508-001BX1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075508-001BX103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075508-001BX12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075508-001BX15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075508-001BX1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075508-001BX1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075508-001BX179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075508-001BX1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075508-001BX11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075508-001BX18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075508-001BX15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075508-001BX15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075508-001BX14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075508-001BX174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075508-001BX1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075508-001BX1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075508-001BX187673890dc5c…
2021-03-12 10:30 UTC2021-03A075508-001BX15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075508-001BX18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075508-001BX1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075508-001BX13f01610625f2…
2019-09-15 20:21 UTC2019-09A075508-001BX1b00525d2431f…
2019-07-19 19:46 UTC2019-07A075508-001BX1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075508-001BX16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075508-001BX11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075508-001BX1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075508-001BX1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075508-001BX19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075508-001BX1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075508-001BX13f0d92c62455…
2023-05-13 08:27 UTC2023-05A075508-001BX1053a50430f4f…
2023-01-26 05:58 UTC2023-01A075508-001BX13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075508-001BX13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075508-001BX1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075508-001BX1e64feba35796…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7W2J09SCWXInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
de40cc65-f955-423f-9cbd-bc2245c4f982Available on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diflorasone DiacetateDIFLORASONE DIACETATESun Pharmaceutical Industries, Inc.b20c9420-8fb4-4a49-93f0-c0e4074d6d712025-09-22Adverse reactionsExact identifier
application applno (ANDA): 075508
application number: ANDA075508
psorconDIFLORASONE DIACETATESun Pharmaceutical Industries, Inc.de40cc65-f955-423f-9cbd-bc2245c4f9822025-07-02Adverse reactionsExact identifier
application applno (ANDA): 075508
application number: ANDA075508
ndc (product): 51672-5292

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