Home NDC 51672-1296 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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A075508-001 DIFLORASONE DIACETATE DIFLORASONE DIACETATE 0.05% CREAM / TOPICAL BX RS 2000-04-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075508-001 BX
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 A075508-001 DIFLORASONE DIACETATE 0.05% CREAM / TOPICAL BX RS 2000-04-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075508-001 DIFLORASONE DIACETATE 0.05% CREAM / TOPICAL BX RS 2000-04-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075508-001 DIFLORASONE DIACETATE 0.05% CREAM / TOPICAL BX RS 2000-04-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075508-001 DIFLORASONE DIACETATE 0.05% CREAM / TOPICAL BX RS 2000-04-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075508-001 DIFLORASONE DIACETATE 0.05% CREAM / TOPICAL BX RS 2000-04-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075508-001 DIFLORASONE DIACETATE 0.05% CREAM / TOPICAL BX RS 2000-04-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075508-001 DIFLORASONE DIACETATE 0.05% CREAM / TOPICAL BX RS 2000-04-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075508-001 DIFLORASONE DIACETATE 0.05% CREAM / TOPICAL BX RS 2000-04-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075508-001 DIFLORASONE DIACETATE 0.05% CREAM / TOPICAL BX RS 2000-04-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075508-001 DIFLORASONE DIACETATE 0.05% CREAM / TOPICAL BX RS 2000-04-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075508-001 DIFLORASONE DIACETATE 0.05% CREAM / TOPICAL BX RS 2000-04-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075508-001 DIFLORASONE DIACETATE 0.05% CREAM / TOPICAL BX RS 2000-04-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075508-001 DIFLORASONE DIACETATE 0.05% CREAM / TOPICAL BX RS 2000-04-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075508-001 DIFLORASONE DIACETATE 0.05% CREAM / TOPICAL BX RS 2000-04-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075508-001 DIFLORASONE DIACETATE 0.05% CREAM / TOPICAL BX RS 2000-04-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075508-001 DIFLORASONE DIACETATE 0.05% CREAM / TOPICAL BX RS 2000-04-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075508-001 DIFLORASONE DIACETATE 0.05% CREAM / TOPICAL BX RS 2000-04-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075508-001 DIFLORASONE DIACETATE 0.05% CREAM / TOPICAL BX RS 2000-04-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075508-001 DIFLORASONE DIACETATE 0.05% CREAM / TOPICAL BX RS 2000-04-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075508-001 DIFLORASONE DIACETATE 0.05% CREAM / TOPICAL BX RS 2000-04-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075508-001 DIFLORASONE DIACETATE 0.05% CREAM / TOPICAL BX RS 2000-04-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075508-001 DIFLORASONE DIACETATE 0.05% CREAM / TOPICAL BX RS 2000-04-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075508-001 DIFLORASONE DIACETATE 0.05% CREAM / TOPICAL BX RS 2000-04-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075508-001 DIFLORASONE DIACETATE 0.05% CREAM / TOPICAL BX RS 2000-04-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075508-001 DIFLORASONE DIACETATE 0.05% CREAM / TOPICAL BX RS 2000-04-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075508-001 DIFLORASONE DIACETATE 0.05% CREAM / TOPICAL BX RS 2000-04-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075508-001 DIFLORASONE DIACETATE 0.05% CREAM / TOPICAL BX RS 2000-04-24 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075508-001 DIFLORASONE DIACETATE 0.05% CREAM / TOPICAL BX RS 2000-04-24 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075508-001 DIFLORASONE DIACETATE 0.05% CREAM / TOPICAL BX RS 2000-04-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075508-001 DIFLORASONE DIACETATE 0.05% CREAM / TOPICAL BX RS 2000-04-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075508-001 DIFLORASONE DIACETATE 0.05% CREAM / TOPICAL BX RS 2000-04-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075508-001 DIFLORASONE DIACETATE 0.05% CREAM / TOPICAL BX RS 2000-04-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075508-001 DIFLORASONE DIACETATE 0.05% CREAM / TOPICAL BX RS 2000-04-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075508-001 DIFLORASONE DIACETATE 0.05% CREAM / TOPICAL BX RS 2000-04-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075508-001 DIFLORASONE DIACETATE 0.05% CREAM / TOPICAL BX RS 2000-04-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075508-001 DIFLORASONE DIACETATE 0.05% CREAM / TOPICAL BX RS 2000-04-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075508-001 DIFLORASONE DIACETATE 0.05% CREAM / TOPICAL BX RS 2000-04-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075508-001 DIFLORASONE DIACETATE 0.05% CREAM / TOPICAL BX RS 2000-04-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075508-001 DIFLORASONE DIACETATE 0.05% CREAM / TOPICAL BX RS 2000-04-24 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075508-001 DIFLORASONE DIACETATE 0.05% CREAM / TOPICAL BX RS 2000-04-24 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 966577 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51672-1296-1 Diflorasone Diacetate 1 in 1 CARTON CREAM 1 7 51672-1296-1 Diflorasone Diacetate 15 g in 1 TUBE CREAM 15 7 51672-1296-2 Diflorasone Diacetate 1 in 1 CARTON CREAM 1 7 51672-1296-2 Diflorasone Diacetate 30 g in 1 TUBE CREAM 30 7 51672-1296-3 Diflorasone Diacetate 1 in 1 CARTON CREAM 1 7 51672-1296-3 Diflorasone Diacetate 60 g in 1 TUBE CREAM 60 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Diflorasone Diacetate ACTIVE INGREDIENT 7W2J09SCWX DIFLORASONE DIACETATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 Diflorasone ACTIVE MOIETY T2DHJ9645W DIFLORASONE DIACETATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 butylated hydroxytoluene INACTIVE INGREDIENT 1P9D0Z171K DIFLORASONE DIACETATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 cetyl alcohol INACTIVE INGREDIENT 936JST6JCN DIFLORASONE DIACETATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 citric acid monohydrate INACTIVE INGREDIENT 2968PHW8QP DIFLORASONE DIACETATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 glyceryl monostearate INACTIVE INGREDIENT 230OU9XXE4 DIFLORASONE DIACETATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 isopropyl myristate INACTIVE INGREDIENT 0RE8K4LNJS DIFLORASONE DIACETATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 lanolin alcohols INACTIVE INGREDIENT 884C3FA9HE DIFLORASONE DIACETATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 mineral oil INACTIVE INGREDIENT T5L8T28FGP DIFLORASONE DIACETATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 palm oil INACTIVE INGREDIENT 5QUO05548Z DIFLORASONE DIACETATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 peg-100 stearate INACTIVE INGREDIENT YD01N1999R DIFLORASONE DIACETATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 polyoxyl 40 stearate INACTIVE INGREDIENT 13A4J4NH9I DIFLORASONE DIACETATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 polysorbate 60 INACTIVE INGREDIENT CAL22UVI4M DIFLORASONE DIACETATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 DIFLORASONE DIACETATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 sodium phosphate, monobasic INACTIVE INGREDIENT 3980JIH2SW DIFLORASONE DIACETATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 sorbitan monostearate INACTIVE INGREDIENT NVZ4I0H58X DIFLORASONE DIACETATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 soybean oil INACTIVE INGREDIENT 241ATL177A DIFLORASONE DIACETATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 water INACTIVE INGREDIENT 059QF0KO0R DIFLORASONE DIACETATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-1296 DIFLORASONE DIACETATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 5 Current NDC, Legacy NDC, 6 package rows 20240616_b20c9420-8fb4-4a49-93f0-c0e4074d6d71.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.
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 51672-1296-1 51672129601 1 TUBE in 1 CARTON (51672-1296-1) / 15 g in 1 TUBE 1 tube 2000-04-24 0000-00-00 No No Current 51672-1296-2 51672129602 1 TUBE in 1 CARTON (51672-1296-2) / 30 g in 1 TUBE 1 tube 2000-04-24 0000-00-00 No No Current 51672-1296-3 51672129603 1 TUBE in 1 CARTON (51672-1296-3) / 60 g in 1 TUBE 1 tube 2000-04-24 0000-00-00 No No Current