Diflorasone Diacetate

Product NDC
71800-009
11-digit product format
718000009
Labeler code
71800
Product ID
71800-009_727a87ee-8629-49f4-8550-bcf670037a8b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diflorasone Diacetate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Innovida Pharmaceutique Corporation
Application
ANDA075331
Marketing category
ANDA
Marketing start
2018-08-15
Marketing end
0000-00-00
Substance
DIFLORASONE DIACETATE
Active strength
1 mg/g
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct71800-009DDiscontinued by firm2026-08-17
excluded packagepackage71800-00971800-009-60DDiscontinued by firm2026-08-17

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
A075331-001DIFLORASONE DIACETATEDIFLORASONE DIACETATE0.05%OINTMENT / TOPICALABRS1999-05-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075331-001AB

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 06:07:402026-07A075331-001DIFLORASONE DIACETATE0.05%OINTMENT / TOPICALABRS1999-05-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075331-001DIFLORASONE DIACETATE0.05%OINTMENT / TOPICALABRS1999-05-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075331-001DIFLORASONE DIACETATE0.05%OINTMENT / TOPICALABRS1999-05-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A075331-001DIFLORASONE DIACETATE0.05%OINTMENT / TOPICALABRS1999-05-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075331-001DIFLORASONE DIACETATE0.05%OINTMENT / TOPICALABRS1999-05-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075331-001DIFLORASONE DIACETATE0.05%OINTMENT / TOPICALABRS1999-05-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075331-001DIFLORASONE DIACETATE0.05%OINTMENT / TOPICALABRS1999-05-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075331-001DIFLORASONE DIACETATE0.05%OINTMENT / TOPICALABRS1999-05-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075331-001DIFLORASONE DIACETATE0.05%OINTMENT / TOPICALABRS1999-05-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075331-001DIFLORASONE DIACETATE0.05%OINTMENT / TOPICALABRS1999-05-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075331-001DIFLORASONE DIACETATE0.05%OINTMENT / TOPICALABRS1999-05-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075331-001DIFLORASONE DIACETATE0.05%OINTMENT / TOPICALABRS1999-05-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075331-001DIFLORASONE DIACETATE0.05%OINTMENT / TOPICALABRS1999-05-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075331-001DIFLORASONE DIACETATE0.05%OINTMENT / TOPICALABRS1999-05-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075331-001DIFLORASONE DIACETATE0.05%OINTMENT / TOPICALABRS1999-05-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075331-001DIFLORASONE DIACETATE0.05%OINTMENT / TOPICALABRS1999-05-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075331-001DIFLORASONE DIACETATE0.05%OINTMENT / TOPICALABRS1999-05-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075331-001DIFLORASONE DIACETATE0.05%OINTMENT / TOPICALABRS1999-05-144b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075331-001DIFLORASONE DIACETATE0.05%OINTMENT / TOPICALABRS1999-05-1474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075331-001DIFLORASONE DIACETATE0.05%OINTMENT / TOPICALABRS1999-05-14bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075331-001DIFLORASONE DIACETATE0.05%OINTMENT / TOPICALABRS1999-05-14782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075331-001DIFLORASONE DIACETATE0.05%OINTMENT / TOPICALABRS1999-05-1487673890dc5c…
2021-03-12 10:30 UTC2021-03A075331-001DIFLORASONE DIACETATE0.05%OINTMENT / TOPICALABRS1999-05-145aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075331-001DIFLORASONE DIACETATE0.05%OINTMENT / TOPICALABRS1999-05-148869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075331-001DIFLORASONE DIACETATE0.05%OINTMENT / TOPICALABRS1999-05-14c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075331-001DIFLORASONE DIACETATE0.05%OINTMENT / TOPICALABRS1999-05-143f01610625f2…
2019-09-15 20:21 UTC2019-09A075331-001DIFLORASONE DIACETATE0.05%OINTMENT / TOPICALABRS1999-05-14b00525d2431f…
2019-07-19 19:46 UTC2019-07A075331-001DIFLORASONE DIACETATE0.05%OINTMENT / TOPICALABRS1999-05-14ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075331-001DIFLORASONE DIACETATE0.05%OINTMENT / TOPICALABRS1999-05-146a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075331-001DIFLORASONE DIACETATE0.05%OINTMENT / TOPICALABRS1999-05-141c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075331-001DIFLORASONE DIACETATE0.05%OINTMENT / TOPICALABRS1999-05-14ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075331-001DIFLORASONE DIACETATE0.05%OINTMENT / TOPICALABRS1999-05-14a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075331-001DIFLORASONE DIACETATE0.05%OINTMENT / TOPICALABRS1999-05-149b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075331-001DIFLORASONE DIACETATE0.05%OINTMENT / TOPICALABRS1999-05-14a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075331-001DIFLORASONE DIACETATE0.05%OINTMENT / TOPICALABRS1999-05-143f0d92c62455…
2023-05-13 08:27 UTC2023-05A075331-001DIFLORASONE DIACETATE0.05%OINTMENT / TOPICALABRS1999-05-14053a50430f4f…
2023-01-26 05:58 UTC2023-01A075331-001DIFLORASONE DIACETATE0.05%OINTMENT / TOPICALABRS1999-05-143bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075331-001DIFLORASONE DIACETATE0.05%OINTMENT / TOPICALABRS1999-05-143a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075331-001DIFLORASONE DIACETATE0.05%OINTMENT / TOPICALABRS1999-05-14f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075331-001DIFLORASONE DIACETATE0.05%OINTMENT / TOPICALABRS1999-05-14e64feba35796…

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 06:07:402026-07A075331-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075331-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075331-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075331-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075331-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075331-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075331-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075331-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075331-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075331-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075331-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075331-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075331-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075331-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075331-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075331-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075331-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075331-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075331-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075331-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075331-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075331-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A075331-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075331-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075331-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075331-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A075331-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A075331-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075331-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075331-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075331-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075331-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075331-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075331-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075331-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A075331-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A075331-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075331-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075331-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075331-001AB1e64feba35796…

DailyMed Product Concepts#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71800-009-60GM - Gram71800-009d7b118c1-0b01-4220-be3e-93391db7211312018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71800-009DIFLORASONE DIACETATE OINTMENT [INNOVIDA PHARMACEUTIQUE CORPORATION]2Legacy NDC20191025_0705869c-b801-4477-b8fe-e06b1cd37352.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diflorasone DiacetateDIFLORASONE DIACETATESun Pharmaceutical Industries, Inc.b304dfca-e840-4c03-8217-73aaa53602772025-07-03Adverse reactionsExact identifier
application applno (ANDA): 075331
application number: ANDA075331

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71800-009-60718000009601 TUBE in 1 CARTON (71800-009-60) > 60 g in 1 TUBE1 tube2018-08-150000-00-00NoNoCurrent