Home NDC 21922-004 Desonide Ointment, 0.05%
Product NDC 21922-004
11-digit product format 219220004
Labeler code 21922
Product ID 21922-004_545fde77-f6c2-4129-b67f-1f8eadd5efde
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Desonide Ointment, 0.05%
Dosage form OINTMENT
Route TOPICAL
Labeler Encube Ethicals, Inc.
Application ANDA210998
Marketing category ANDA
Marketing start 2019-03-20
Substance DESONIDE
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 A210998-001 DESONIDE DESONIDE 0.05% OINTMENT / TOPICAL AB 2019-01-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A210998-001 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 A210998-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 2019-01-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210998-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 2019-01-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210998-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 2019-01-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210998-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 2019-01-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210998-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 2019-01-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210998-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 2019-01-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210998-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 2019-01-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210998-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 2019-01-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210998-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 2019-01-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210998-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 2019-01-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210998-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 2019-01-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210998-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 2019-01-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210998-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 2019-01-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210998-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 2019-01-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210998-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 2019-01-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210998-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 2019-01-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210998-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 2019-01-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A210998-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 2019-01-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A210998-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 2019-01-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210998-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 2019-01-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210998-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 2019-01-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A210998-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 2019-01-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A210998-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 2019-01-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A210998-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 2019-01-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A210998-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 2019-01-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A210998-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 2019-01-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A210998-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 2019-01-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210998-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 2019-01-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210998-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 2019-01-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A210998-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 2019-01-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210998-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 2019-01-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210998-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 2019-01-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210998-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 2019-01-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A210998-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 2019-01-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A210998-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 2019-01-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A210998-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 2019-01-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A210998-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 2019-01-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A210998-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 2019-01-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A210998-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 2019-01-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A210998-001 DESONIDE 0.05% OINTMENT / TOPICAL AB 2019-01-30 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 Desonide Ointment, 0.05%
Listing expiration 2027-12-31 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 204135 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 21922-004-04 Desonide Ointment, 0.05% 15 g in 1 TUBE OINTMENT 15 8 21922-004-04 Desonide Ointment, 0.05% 01 in 1 CARTON OINTMENT 01 8 21922-004-07 Desonide Ointment, 0.05% 01 in 1 CARTON OINTMENT 01 8 21922-004-07 Desonide Ointment, 0.05% 60 g in 1 TUBE OINTMENT 60 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 21922-004 DESONIDE OINTMENT, 0.05% OINTMENT [ENCUBE ETHICALS PRIVATE LIMITED] 6 Current NDC, Legacy NDC, 4 package rows 20241222_3d4d19d4-e47b-407e-9df4-fed5f3db91b9.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Desonide Ointment, 0.05% DESONIDE OINTMENT, 0.05% Bryant Ranch Prepack d5fb23d8-a39e-4cf9-9a89-2de9dfafbb4d 2026-06-16 Adverse reactions Exact identifier application applno (ANDA): 210998 application number: ANDA210998 Desonide Ointment, 0.05% DESONIDE OINTMENT, 0.05% Bryant Ranch Prepack 1d796425-8fd6-4024-888d-0056627f7190 2026-05-28 Adverse reactions Exact identifier application applno (ANDA): 210998 application number: ANDA210998 Desonide Ointment, 0.05% DESONIDE OINTMENT, 0.05% Bryant Ranch Prepack 569d363a-85d3-430f-b528-55ddb4b8fbae 2026-05-28 Adverse reactions Exact identifier application applno (ANDA): 210998 application number: ANDA210998 Desonide Ointment, 0.05% DESONIDE OINTMENT, 0.05% Encube Ethicals, Inc. 3d4d19d4-e47b-407e-9df4-fed5f3db91b9 2026-03-09 Adverse reactions Exact identifier application applno (ANDA): 210998 application number: ANDA210998 ndc (product): 21922-004
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 21922-004-04 21922000404 1 TUBE in 1 CARTON (21922-004-04) / 15 g in 1 TUBE 1 tube 2019-03-20 0000-00-00 No No Current 21922-004-07 21922000407 1 TUBE in 1 CARTON (21922-004-07) / 60 g in 1 TUBE 1 tube 2019-03-20 0000-00-00 No No Current