Desonide

Product NDC
62332-485
11-digit product format
623320485
Labeler code
62332
Product ID
62332-485_8c111579-9635-4d85-b10d-e42399a751ff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desonide
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA212473
Marketing category
ANDA
Marketing start
2019-10-24
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 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A212473-001DESONIDEDESONIDE0.05%OINTMENT / TOPICALAB2019-10-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A212473-001AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A212473-001DESONIDE0.05%OINTMENT / TOPICALAB2019-10-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A212473-001DESONIDE0.05%OINTMENT / TOPICALAB2019-10-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212473-001DESONIDE0.05%OINTMENT / TOPICALAB2019-10-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A212473-001DESONIDE0.05%OINTMENT / TOPICALAB2019-10-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212473-001DESONIDE0.05%OINTMENT / TOPICALAB2019-10-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212473-001DESONIDE0.05%OINTMENT / TOPICALAB2019-10-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212473-001DESONIDE0.05%OINTMENT / TOPICALAB2019-10-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212473-001DESONIDE0.05%OINTMENT / TOPICALAB2019-10-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212473-001DESONIDE0.05%OINTMENT / TOPICALAB2019-10-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212473-001DESONIDE0.05%OINTMENT / TOPICALAB2019-10-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212473-001DESONIDE0.05%OINTMENT / TOPICALAB2019-10-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212473-001DESONIDE0.05%OINTMENT / TOPICALAB2019-10-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212473-001DESONIDE0.05%OINTMENT / TOPICALAB2019-10-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212473-001DESONIDE0.05%OINTMENT / TOPICALAB2019-10-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212473-001DESONIDE0.05%OINTMENT / TOPICALAB2019-10-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212473-001DESONIDE0.05%OINTMENT / TOPICALAB2019-10-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A212473-001DESONIDE0.05%OINTMENT / TOPICALAB2019-10-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A212473-001DESONIDE0.05%OINTMENT / TOPICALAB2019-10-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A212473-001DESONIDE0.05%OINTMENT / TOPICALAB2019-10-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A212473-001DESONIDE0.05%OINTMENT / TOPICALAB2019-10-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A212473-001DESONIDE0.05%OINTMENT / TOPICALAB2019-10-23782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A212473-001DESONIDE0.05%OINTMENT / TOPICALAB2019-10-2387673890dc5c…
2021-03-12 10:30 UTC2021-03A212473-001DESONIDE0.05%OINTMENT / TOPICALAB2019-10-235aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A212473-001DESONIDE0.05%OINTMENT / TOPICALAB2019-10-238869cabd3fbd…
2020-11-12 02:37 UTC2020-11A212473-001DESONIDE0.05%OINTMENT / TOPICALAB2019-10-23c0c555d07b60…
2019-12-14 00:12 UTC2019-12A212473-001DESONIDE0.05%OINTMENT / TOPICALAB2019-10-233f01610625f2…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A212473-001DESONIDE0.05%OINTMENT / TOPICALAB2019-10-236a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A212473-001DESONIDE0.05%OINTMENT / TOPICALAB2019-10-231c564ffb4f44…
2023-12-20 04:57 UTC2023-12A212473-001DESONIDE0.05%OINTMENT / TOPICALAB2019-10-23ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A212473-001DESONIDE0.05%OINTMENT / TOPICALAB2019-10-23a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A212473-001DESONIDE0.05%OINTMENT / TOPICALAB2019-10-239b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A212473-001DESONIDE0.05%OINTMENT / TOPICALAB2019-10-23a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A212473-001DESONIDE0.05%OINTMENT / TOPICALAB2019-10-233f0d92c62455…
2023-05-13 08:27 UTC2023-05A212473-001DESONIDE0.05%OINTMENT / TOPICALAB2019-10-23053a50430f4f…
2023-01-26 05:58 UTC2023-01A212473-001DESONIDE0.05%OINTMENT / TOPICALAB2019-10-233bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A212473-001DESONIDE0.05%OINTMENT / TOPICALAB2019-10-233a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A212473-001DESONIDE0.05%OINTMENT / TOPICALAB2019-10-23f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A212473-001DESONIDE0.05%OINTMENT / TOPICALAB2019-10-23e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A212473-001DESONIDE0.05%OINTMENT / TOPICALAB2019-10-23cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212473-001DESONIDE0.05%OINTMENT / TOPICALAB2019-10-23a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A212473-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A212473-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212473-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A212473-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212473-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212473-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212473-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212473-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212473-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212473-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212473-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212473-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212473-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212473-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212473-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212473-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A212473-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A212473-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A212473-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A212473-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A212473-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A212473-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A212473-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A212473-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A212473-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A212473-001AB13f01610625f2…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A212473-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A212473-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A212473-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A212473-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A212473-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A212473-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A212473-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A212473-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A212473-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A212473-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A212473-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A212473-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A212473-001AB1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212473-001AB1a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Desonide
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DESONIDE.5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
J280872D1OInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
204135Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9eade7ae-effc-49b5-af7d-8caa183ff252Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5dd568b3-c283-39c3-9c72-0b51d8c13e5dProduct name220201006
0d789796-3334-08b7-795a-b9c3762179bcProduct name220200506
6da396dc-a1b2-d109-14be-877a0fdbfa18Product name520200408
4fa39b20-3e53-46d7-85e4-edc2360cfdffProduct name120171115
a4783074-7e0b-e965-10c3-0421e26d5edeProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62332-485-15Desonide1 in 1 CARTONOINTMENT18
62332-485-15Desonide15 g in 1 TUBEOINTMENT158
62332-485-60Desonide1 in 1 CARTONOINTMENT18
62332-485-60Desonide60 g in 1 TUBEOINTMENT608

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-485-15GM - Gram62332-485ffd67239-20d6-43cf-8e83-02b27434088612020-01-03
62332-485-60GM - Gram62332-4857f01f1c5-0b7d-439a-8926-e92a61a7380112020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-485DESONIDE OINTMENT [ALEMBIC PHARMACEUTICALS INC.]7Current NDC, Legacy NDC, 4 package rows20230721_9eade7ae-effc-49b5-af7d-8caa183ff252.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DesonideDESONIDEAlembic Pharmaceuticals Inc.9eade7ae-effc-49b5-af7d-8caa183ff2522026-04-17Adverse reactionsExact identifier
application applno (ANDA): 212473
application number: ANDA212473
ndc (product): 62332-485
DesonideDESONIDEAlembic Pharmaceuticals Limited591762b3-f223-49a1-8e65-63e9086110df2025-03-07Adverse reactionsExact identifier
application applno (ANDA): 212473
application number: ANDA212473

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204135desonide 0.05 % Topical OintmentPSN9eade7ae-effc-49b5-af7d-8caa183ff2528
204135desonide 0.0005 MG/MG Topical OintmentSCD9eade7ae-effc-49b5-af7d-8caa183ff2528
204135desonide 0.05 % Topical OintmentSY9eade7ae-effc-49b5-af7d-8caa183ff2528

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62332-485-15623320485151 TUBE in 1 CARTON (62332-485-15) / 15 g in 1 TUBE1 tube2019-10-240000-00-00NoNoCurrent
62332-485-60623320485601 TUBE in 1 CARTON (62332-485-60) / 60 g in 1 TUBE1 tube2019-10-240000-00-00NoNoCurrent