Home NDC 80425-0418 Desonide
Product NDC 80425-0418
11-digit product format 804250418
Labeler code 80425
Product ID 80425-0418_1d76541f-80d7-2a55-e063-6294a90aa5f9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Desonide
Dosage form CREAM
Route TOPICAL
Labeler Advanced Rx of Tennessee, LLC
Application ANDA074027
Marketing category ANDA
Marketing start 2024-07-17
Substance DESONIDE
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 A074027-001 DESONIDE DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A074027-001 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 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A074027-001 DESONIDE 0.05% CREAM / TOPICAL AB 1992-09-28 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 Desonide
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DESONIDE .5 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination J280872D1O Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 349351 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 80425-0418-1 Desonide 1 in 1 CARTON CREAM 1 1 80425-0418-1 Desonide 60 g in 1 TUBE CREAM 60 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80425-0418 DESONIDE CREAM [ADVANCED RX OF TENNESSEE, LLC] 1 Current NDC, 2 package rows 20240719_1d7632a7-0f27-9e5d-e063-6294a90ad21f.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 Sample Exclude flag Status 80425-0418-1 80425041801 1 TUBE in 1 CARTON (80425-0418-1) / 60 g in 1 TUBE 1 tube 2024-07-17 No No Current