Home NDC 71656-087 DESOXIMETASONE
Product NDC 71656-087
11-digit product format 716560087
Labeler code 71656
Product ID 71656-087_513a7c3c-05ee-9414-e063-6394a90a3500
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name DESOXIMETASONE
Dosage form CREAM
Route TOPICAL
Labeler Saptalis Pharmaceuticals, LLC.
Application ANDA203234
Marketing category ANDA
Marketing start 2026-05-07
Substance DESOXIMETASONE
Active strength 2.5 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 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 A203234-001 DESOXIMETASONE DESOXIMETASONE 0.25% CREAM / TOPICAL AB 2015-06-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A203234-001 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 A203234-001 DESOXIMETASONE 0.25% CREAM / TOPICAL AB 2015-06-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203234-001 DESOXIMETASONE 0.25% CREAM / TOPICAL 2015-06-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203234-001 DESOXIMETASONE 0.25% CREAM / TOPICAL 2015-06-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203234-001 DESOXIMETASONE 0.25% CREAM / TOPICAL 2015-06-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203234-001 DESOXIMETASONE 0.25% CREAM / TOPICAL 2015-06-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203234-001 DESOXIMETASONE 0.25% CREAM / TOPICAL 2015-06-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203234-001 DESOXIMETASONE 0.25% CREAM / TOPICAL 2015-06-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203234-001 DESOXIMETASONE 0.25% CREAM / TOPICAL 2015-06-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203234-001 DESOXIMETASONE 0.25% CREAM / TOPICAL 2015-06-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203234-001 DESOXIMETASONE 0.25% CREAM / TOPICAL 2015-06-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203234-001 DESOXIMETASONE 0.25% CREAM / TOPICAL 2015-06-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203234-001 DESOXIMETASONE 0.25% CREAM / TOPICAL 2015-06-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203234-001 DESOXIMETASONE 0.25% CREAM / TOPICAL 2015-06-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203234-001 DESOXIMETASONE 0.25% CREAM / TOPICAL 2015-06-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203234-001 DESOXIMETASONE 0.25% CREAM / TOPICAL 2015-06-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203234-001 DESOXIMETASONE 0.25% CREAM / TOPICAL 2015-06-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203234-001 DESOXIMETASONE 0.25% CREAM / TOPICAL 2015-06-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203234-001 DESOXIMETASONE 0.25% CREAM / TOPICAL 2015-06-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203234-001 DESOXIMETASONE 0.25% CREAM / TOPICAL AB 2015-06-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203234-001 DESOXIMETASONE 0.25% CREAM / TOPICAL 2015-06-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203234-001 DESOXIMETASONE 0.25% CREAM / TOPICAL 2015-06-12 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203234-001 DESOXIMETASONE 0.25% CREAM / TOPICAL AB 2015-06-12 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A203234-001 DESOXIMETASONE 0.25% CREAM / TOPICAL AB 2015-06-12 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A203234-001 DESOXIMETASONE 0.25% CREAM / TOPICAL AB 2015-06-12 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A203234-001 DESOXIMETASONE 0.25% CREAM / TOPICAL AB 2015-06-12 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A203234-001 DESOXIMETASONE 0.25% CREAM / TOPICAL AB 2015-06-12 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A203234-001 DESOXIMETASONE 0.25% CREAM / TOPICAL AB 2015-06-12 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A203234-001 DESOXIMETASONE 0.25% CREAM / TOPICAL AB 2015-06-12 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203234-001 DESOXIMETASONE 0.25% CREAM / TOPICAL 2015-06-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A203234-001 DESOXIMETASONE 0.25% CREAM / TOPICAL 2015-06-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A203234-001 DESOXIMETASONE 0.25% CREAM / TOPICAL 2015-06-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A203234-001 DESOXIMETASONE 0.25% CREAM / TOPICAL 2015-06-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A203234-001 DESOXIMETASONE 0.25% CREAM / TOPICAL 2015-06-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A203234-001 DESOXIMETASONE 0.25% CREAM / TOPICAL 2015-06-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A203234-001 DESOXIMETASONE 0.25% CREAM / TOPICAL 2015-06-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A203234-001 DESOXIMETASONE 0.25% CREAM / TOPICAL 2015-06-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A203234-001 DESOXIMETASONE 0.25% CREAM / TOPICAL 2015-06-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A203234-001 DESOXIMETASONE 0.25% CREAM / TOPICAL 2015-06-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A203234-001 DESOXIMETASONE 0.25% CREAM / TOPICAL 2015-06-12 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A203234-001 DESOXIMETASONE 0.25% CREAM / TOPICAL 2015-06-12 e64feba35796…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base DESOXIMETASONE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DESOXIMETASONE 2.5 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197574 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 71656-087-15 DESOXIMETASONE 15 in 1 CARTON CREAM 15 3 71656-087-15 DESOXIMETASONE 15 g in 1 TUBE CREAM 15 3 71656-087-60 DESOXIMETASONE 60 in 1 CARTON CREAM 60 3 71656-087-60 DESOXIMETASONE 60 g in 1 TUBE CREAM 60 3
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 Sample Exclude flag Status 71656-087-15 71656008715 15 TUBE in 1 CARTON (71656-087-15) / 15 g in 1 TUBE 15 tube 2026-05-07 No No Current 71656-087-60 71656008760 60 TUBE in 1 CARTON (71656-087-60) / 60 g in 1 TUBE 60 tube 2026-05-07 No No Current