Home NDC 51672-5263-5 Topicort
Product NDC 51672-5263
Requested package NDC 51672-5263-5
11-digit product format 516725263
Labeler code 51672
Product ID 51672-5263_4cd6638c-db25-e28b-e063-6294a90a4a9a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Desoximetasone
Dosage form OINTMENT
Route TOPICAL
Labeler Sun Pharmaceutical Industries, Inc.
Application NDA018594
Marketing category NDA
Marketing start 1985-01-17
Substance DESOXIMETASONE
Active strength .5 mg/g
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N018594-001 TOPICORT DESOXIMETASONE 0.05% OINTMENT / TOPICAL AB RLD, RS 1985-01-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N018594-001 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 · 41 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 2026-02-19 14:30 UTC 2026-02 N018594-001 TOPICORT 0.05% OINTMENT / TOPICAL AB RLD, RS 1985-01-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018594-001 TOPICORT 0.05% OINTMENT / TOPICAL AB RLD, RS 1985-01-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N018594-001 TOPICORT 0.05% OINTMENT / TOPICAL AB RLD, RS 1985-01-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018594-001 TOPICORT 0.05% OINTMENT / TOPICAL AB RLD, RS 1985-01-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018594-001 TOPICORT 0.05% OINTMENT / TOPICAL AB RLD, RS 1985-01-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018594-001 TOPICORT 0.05% OINTMENT / TOPICAL AB RLD, RS 1985-01-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018594-001 TOPICORT 0.05% OINTMENT / TOPICAL AB RLD, RS 1985-01-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018594-001 TOPICORT 0.05% OINTMENT / TOPICAL AB RLD, RS 1985-01-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018594-001 TOPICORT 0.05% OINTMENT / TOPICAL AB RLD, RS 1985-01-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N018594-001 TOPICORT 0.05% OINTMENT / TOPICAL AB RLD, RS 1985-01-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018594-001 TOPICORT 0.05% OINTMENT / TOPICAL AB RLD, RS 1985-01-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018594-001 TOPICORT 0.05% OINTMENT / TOPICAL AB RLD, RS 1985-01-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018594-001 TOPICORT 0.05% OINTMENT / TOPICAL AB RLD, RS 1985-01-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N018594-001 TOPICORT 0.05% OINTMENT / TOPICAL AB RLD, RS 1985-01-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N018594-001 TOPICORT 0.05% OINTMENT / TOPICAL AB RLD, RS 1985-01-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N018594-001 TOPICORT 0.05% OINTMENT / TOPICAL AB RLD, RS 1985-01-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N018594-001 TOPICORT 0.05% OINTMENT / TOPICAL AB RLD, RS 1985-01-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N018594-001 TOPICORT 0.05% OINTMENT / TOPICAL AB RLD, RS 1985-01-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N018594-001 TOPICORT 0.05% OINTMENT / TOPICAL AB RLD, RS 1985-01-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N018594-001 TOPICORT 0.05% OINTMENT / TOPICAL AB RLD, RS 1985-01-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N018594-001 TOPICORT 0.05% OINTMENT / TOPICAL AB RLD, RS 1985-01-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N018594-001 TOPICORT 0.05% OINTMENT / TOPICAL AB RLD, RS 1985-01-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N018594-001 TOPICORT 0.05% OINTMENT / TOPICAL AB RLD, RS 1985-01-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N018594-001 TOPICORT 0.05% OINTMENT / TOPICAL AB RLD, RS 1985-01-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N018594-001 TOPICORT 0.05% OINTMENT / TOPICAL AB RLD, RS 1985-01-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N018594-001 TOPICORT 0.05% OINTMENT / TOPICAL AB RLD, RS 1985-01-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N018594-001 TOPICORT 0.05% OINTMENT / TOPICAL AB RLD, RS 1985-01-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N018594-001 TOPICORT 0.05% OINTMENT / TOPICAL AB RLD, RS 1985-01-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N018594-001 TOPICORT 0.05% OINTMENT / TOPICAL AB RLD, RS 1985-01-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N018594-001 TOPICORT 0.05% OINTMENT / TOPICAL AB RLD, RS 1985-01-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N018594-001 TOPICORT 0.05% OINTMENT / TOPICAL AB RLD, RS 1985-01-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N018594-001 TOPICORT 0.05% OINTMENT / TOPICAL AB RLD, RS 1985-01-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N018594-001 TOPICORT 0.05% OINTMENT / TOPICAL AB RLD, RS 1985-01-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N018594-001 TOPICORT 0.05% OINTMENT / TOPICAL AB RLD, RS 1985-01-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N018594-001 TOPICORT 0.05% OINTMENT / TOPICAL AB RLD, RS 1985-01-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N018594-001 TOPICORT 0.05% OINTMENT / TOPICAL AB RLD, RS 1985-01-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N018594-001 TOPICORT 0.05% OINTMENT / TOPICAL AB RLD, RS 1985-01-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N018594-001 TOPICORT 0.05% OINTMENT / TOPICAL AB RLD, RS 1985-01-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N018594-001 TOPICORT 0.05% OINTMENT / TOPICAL AB RLD, RS 1985-01-17 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N018594-001 TOPICORT 0.05% OINTMENT / TOPICAL AB RLD, RS 1985-01-17 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Topicort
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DESOXIMETASONE .5 mg/g
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 141850 Internal RxNorm lookup 1050394 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 51672-5263 TOPICORT (DESOXIMETASONE) OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.] 9 Current NDC, Legacy NDC, 10 package rows 20241222_96dfac6f-540f-4b7d-bcee-7e62088ebc93.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 51672-5263-5 51672526305 10 TUBE in 1 CARTON (51672-5263-5) / 5 g in 1 TUBE 10 tube 1985-01-17 0000-00-00 No No Current