Home NDC 51672-1295 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 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075331-001 DIFLORASONE DIACETATE DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB RS 1999-05-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075331-001 AB
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A075331-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB RS 1999-05-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075331-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB RS 1999-05-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075331-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB RS 1999-05-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075331-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB RS 1999-05-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075331-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB RS 1999-05-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075331-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB RS 1999-05-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075331-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB RS 1999-05-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075331-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB RS 1999-05-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075331-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB RS 1999-05-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075331-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB RS 1999-05-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075331-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB RS 1999-05-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075331-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB RS 1999-05-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075331-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB RS 1999-05-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075331-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB RS 1999-05-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075331-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB RS 1999-05-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075331-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB RS 1999-05-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075331-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB RS 1999-05-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075331-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB RS 1999-05-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075331-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB RS 1999-05-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075331-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB RS 1999-05-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075331-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB RS 1999-05-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075331-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB RS 1999-05-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075331-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB RS 1999-05-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075331-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB RS 1999-05-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075331-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB RS 1999-05-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075331-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB RS 1999-05-14 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075331-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB RS 1999-05-14 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075331-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB RS 1999-05-14 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075331-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB RS 1999-05-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075331-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB RS 1999-05-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075331-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB RS 1999-05-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075331-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB RS 1999-05-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075331-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB RS 1999-05-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075331-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB RS 1999-05-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075331-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB RS 1999-05-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075331-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB RS 1999-05-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075331-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB RS 1999-05-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075331-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB RS 1999-05-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075331-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB RS 1999-05-14 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075331-001 DIFLORASONE DIACETATE 0.05% OINTMENT / TOPICAL AB RS 1999-05-14 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Diflorasone Diacetate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIFLORASONE DIACETATE .5 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7W2J09SCWX Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 966607 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51672-1295-1 Diflorasone Diacetate 1 in 1 CARTON OINTMENT 1 6 51672-1295-1 Diflorasone Diacetate 15 g in 1 TUBE OINTMENT 15 6 51672-1295-2 Diflorasone Diacetate 30 g in 1 TUBE OINTMENT 30 6 51672-1295-2 Diflorasone Diacetate 1 in 1 CARTON OINTMENT 1 6 51672-1295-3 Diflorasone Diacetate 60 g in 1 TUBE OINTMENT 60 6 51672-1295-3 Diflorasone Diacetate 1 in 1 CARTON OINTMENT 1 6
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-1295 DIFLORASONE DIACETATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 5 Current NDC, Legacy NDC, 6 package rows 20241222_b304dfca-e840-4c03-8217-73aaa5360277.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51672-1295-1 51672129501 1 TUBE in 1 CARTON (51672-1295-1) / 15 g in 1 TUBE 1 tube 1999-05-14 0000-00-00 No No Current 51672-1295-2 51672129502 1 TUBE in 1 CARTON (51672-1295-2) / 30 g in 1 TUBE 1 tube 1999-05-14 0000-00-00 No No Current 51672-1295-3 51672129503 1 TUBE in 1 CARTON (51672-1295-3) / 60 g in 1 TUBE 1 tube 1999-05-14 0000-00-00 No No Current