Home NDC 63629-8739 Desonide
Product NDC 63629-8739
11-digit product format 636298739
Labeler code 63629
Product ID 63629-8739_4ebc6b9d-b5a2-47fd-88b2-7bbd16ae6fea
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name desonide
Dosage form LOTION
Route TOPICAL
Labeler Bryant Ranch Prepack
Application ANDA072354
Marketing category ANDA
Marketing start 2009-05-28
Substance DESONIDE
Active strength .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 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 A072354-001 DESOWEN DESONIDE 0.05% LOTION / TOPICAL 1992-01-24
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 A072354-001 DESOWEN 0.05% LOTION / TOPICAL 1992-01-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A072354-001 DESOWEN 0.05% LOTION / TOPICAL 1992-01-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A072354-001 DESOWEN 0.05% LOTION / TOPICAL AB RS 1992-01-24 cb3db0bc1861…
Observed Orange Book normalized TE history# 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/mL
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 197572 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 63629-8739-1 Desonide 59 mL in 1 BOTTLE LOTION 59 104 63629-8739-1 Desonide 1 in 1 CARTON LOTION 1 104
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63629-8739 DESONIDE LOTION [BRYANT RANCH PREPACK] 103 Current NDC, Legacy NDC, 2 package rows 20241101_84ceca9d-94af-46a2-be96-601892f2c535.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 63629-8739-1 63629873901 1 BOTTLE in 1 CARTON (63629-8739-1) / 59 mL in 1 BOTTLE 1 bottle 2021-08-19 0000-00-00 No No Current