Home NDC 51672-5281 Topicort
Product NDC 51672-5281
11-digit product format 516725281
Labeler code 51672
Product ID 51672-5281_38f9cadb-290c-0c68-e063-6394a90a38d9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Desoximetasone
Dosage form SPRAY
Route TOPICAL
Labeler Sun Pharmaceutical Industries, Inc.
Application NDA204141
Marketing category NDA
Marketing start 2013-04-11
Substance DESOXIMETASONE
Active strength 2.5 mg/mL
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 N204141-001 TOPICORT DESOXIMETASONE 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N204141-001 AT
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N204141-001 8715624 2026-05-26 U-1408 Drug product 2014-06-13 N204141-001 8277780 2028-09-01 U-1408 Drug product 2013-06-26
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 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N204141-001 TOPICORT 0.25% SPRAY / TOPICAL AT RLD, RS 2013-04-11 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Observed Orange Book patent history# Patent history page 1 of 3 · 84 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N204141-001 8715624 2026-05-26 U-1408 Drug product 2014-06-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N204141-001 8277780 2028-09-01 U-1408 Drug product 2013-06-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N204141-001 8715624 2026-05-26 U-1408 Drug product 2014-06-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204141-001 8277780 2028-09-01 U-1408 Drug product 2013-06-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204141-001 8715624 2026-05-26 U-1408 Drug product 2014-06-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204141-001 8277780 2028-09-01 U-1408 Drug product 2013-06-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N204141-001 8715624 2026-05-26 U-1408 Drug product 2014-06-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204141-001 8277780 2028-09-01 U-1408 Drug product 2013-06-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204141-001 8715624 2026-05-26 U-1408 Drug product 2014-06-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204141-001 8277780 2028-09-01 U-1408 Drug product 2013-06-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204141-001 8715624 2026-05-26 U-1408 Drug product 2014-06-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204141-001 8277780 2028-09-01 U-1408 Drug product 2013-06-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204141-001 8715624 2026-05-26 U-1408 Drug product 2014-06-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204141-001 8277780 2028-09-01 U-1408 Drug product 2013-06-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204141-001 8715624 2026-05-26 U-1408 Drug product 2014-06-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204141-001 8277780 2028-09-01 U-1408 Drug product 2013-06-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204141-001 8715624 2026-05-26 U-1408 Drug product 2014-06-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204141-001 8277780 2028-09-01 U-1408 Drug product 2013-06-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204141-001 8715624 2026-05-26 U-1408 Drug product 2014-06-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204141-001 8277780 2028-09-01 U-1408 Drug product 2013-06-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N204141-001 8715624 2026-05-26 U-1408 Drug product 2014-06-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N204141-001 8277780 2028-09-01 U-1408 Drug product 2013-06-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N204141-001 8715624 2026-05-26 U-1408 Drug product 2014-06-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N204141-001 8277780 2028-09-01 U-1408 Drug product 2013-06-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N204141-001 8715624 2026-05-26 U-1408 Drug product 2014-06-13 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N204141-001 8277780 2028-09-01 U-1408 Drug product 2013-06-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N204141-001 8715624 2026-05-26 U-1408 Drug product 2014-06-13 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N204141-001 8277780 2028-09-01 U-1408 Drug product 2013-06-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N204141-001 8715624 2026-05-26 U-1408 Drug product 2014-06-13 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N204141-001 8277780 2028-09-01 U-1408 Drug product 2013-06-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N204141-001 8715624 2026-05-26 U-1408 Drug product 2014-06-13 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N204141-001 8277780 2028-09-01 U-1408 Drug product 2013-06-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N204141-001 8715624 2026-05-26 U-1408 Drug product 2014-06-13 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N204141-001 8277780 2028-09-01 U-1408 Drug product 2013-06-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N204141-001 8715624 2026-05-26 U-1408 Drug product 2014-06-13 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N204141-001 8277780 2028-09-01 U-1408 Drug product 2013-06-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N204141-001 8715624 2026-05-26 U-1408 Drug product 2014-06-13 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N204141-001 8277780 2028-09-01 U-1408 Drug product 2013-06-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N204141-001 8715624 2026-05-26 U-1408 Drug product 2014-06-13 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N204141-001 8277780 2028-09-01 U-1408 Drug product 2013-06-26 bb7c543d1eb4…
Additional Listing Data#
Finished product Yes
Brand name base Topicort
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DESOXIMETASONE 2.5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4E07GXB7AU Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1376338 Internal RxNorm lookup 1376340 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-5281 TOPICORT (DESOXIMETASONE) SPRAY [TARO PHARMACEUTICALS U.S.A., INC.] 10 Current NDC, Legacy NDC, 10 package rows 20211016_e417856a-b760-4626-bc34-8e4bc62c026c.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 51672-5281-0 51672528100 1 BOTTLE in 1 CARTON (51672-5281-0) / 6 mL in 1 BOTTLE 1 bottle 2013-04-11 0000-00-00 No No Current 51672-5281-3 51672528103 1 BOTTLE in 1 CARTON (51672-5281-3) / 30 mL in 1 BOTTLE 1 bottle 2013-04-11 0000-00-00 No No Current 51672-5281-4 51672528104 1 BOTTLE in 1 CARTON (51672-5281-4) / 50 mL in 1 BOTTLE 1 bottle 2013-04-11 0000-00-00 No No Current 51672-5281-6 51672528106 2 BOTTLE in 1 CARTON (51672-5281-6) / 50 mL in 1 BOTTLE 2 bottle 2013-04-11 0000-00-00 No No Current 51672-5281-7 51672528107 1 BOTTLE in 1 CARTON (51672-5281-7) / 100 mL in 1 BOTTLE 1 bottle 2013-04-11 0000-00-00 No No Current