Home NDC 50436-3300-1 Desonide
Product NDC 50436-3300
Requested package NDC 50436-3300-1
11-digit product format 504363300
Labeler code 50436
Product ID 50436-3300_80c5fac9-05cb-43ef-9f41-e6e21ec600f3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Desonide
Dosage form CREAM
Route TOPICAL
Labeler Unit Dose Services
Application ANDA074027
Marketing category ANDA
Marketing start 2016-08-19
Marketing end 0000-00-00
Substance DESONIDE
Active strength 1 mg/g
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
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.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50436-3300-1 Desonide 60 g in 1 TUBE CREAM 60 2 50436-3300-1 Desonide 1 in 1 CARTON CREAM 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50436-3300 DESONIDE (DESONIDE) CREAM [UNIT DOSE SERVICES] 2 Legacy NDC, 2 package rows 20220803_843dc9e3-9edf-43da-aa0b-ff25dcd440e6.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 50436-3300-1 50436330001 1 TUBE in 1 CARTON (50436-3300-1) > 60 g in 1 TUBE 1 tube 2022-08-01 0000-00-00 No No Current