Desonide

Product NDC
62332-550
11-digit product format
623320550
Labeler code
62332
Product ID
62332-550_4e393b66-a7f8-4d45-8c2e-ab1af845da41
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desonide
Dosage form
LOTION
Route
TOPICAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA213632
Marketing category
ANDA
Marketing start
2020-08-28
Substance
DESONIDE
Active strength
.5 mg/mL
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
A213632-001DESONIDEDESONIDE0.05%LOTION / TOPICALABRS2020-08-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A213632-001AB

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 06:07:402026-07A213632-001DESONIDE0.05%LOTION / TOPICALABRS2020-08-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213632-001DESONIDE0.05%LOTION / TOPICALABRS2020-08-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213632-001DESONIDE0.05%LOTION / TOPICALABRS2020-08-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A213632-001DESONIDE0.05%LOTION / TOPICALAB2020-08-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213632-001DESONIDE0.05%LOTION / TOPICALAB2020-08-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213632-001DESONIDE0.05%LOTION / TOPICALAB2020-08-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213632-001DESONIDE0.05%LOTION / TOPICALAB2020-08-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213632-001DESONIDE0.05%LOTION / TOPICALAB2020-08-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213632-001DESONIDE0.05%LOTION / TOPICALAB2020-08-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213632-001DESONIDE0.05%LOTION / TOPICALAB2020-08-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213632-001DESONIDE0.05%LOTION / TOPICALAB2020-08-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213632-001DESONIDE0.05%LOTION / TOPICALAB2020-08-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213632-001DESONIDE0.05%LOTION / TOPICALAB2020-08-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213632-001DESONIDE0.05%LOTION / TOPICALAB2020-08-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213632-001DESONIDE0.05%LOTION / TOPICALAB2020-08-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213632-001DESONIDE0.05%LOTION / TOPICALAB2020-08-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A213632-001DESONIDE0.05%LOTION / TOPICALAB2020-08-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A213632-001DESONIDE0.05%LOTION / TOPICALAB2020-08-244b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A213632-001DESONIDE0.05%LOTION / TOPICALAB2020-08-24bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A213632-001DESONIDE0.05%LOTION / TOPICALAB2020-08-24782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A213632-001DESONIDE0.05%LOTION / TOPICALAB2020-08-2487673890dc5c…
2021-03-12 10:30 UTC2021-03A213632-001DESONIDE0.05%LOTION / TOPICALAB2020-08-245aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A213632-001DESONIDE0.05%LOTION / TOPICALAB2020-08-248869cabd3fbd…
2020-11-12 02:37 UTC2020-11A213632-001DESONIDE0.05%LOTION / TOPICALAB2020-08-24c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213632-001DESONIDE0.05%LOTION / TOPICALAB2020-08-246a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A213632-001DESONIDE0.05%LOTION / TOPICALAB2020-08-241c564ffb4f44…
2023-12-20 04:57 UTC2023-12A213632-001DESONIDE0.05%LOTION / TOPICALAB2020-08-24ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A213632-001DESONIDE0.05%LOTION / TOPICALAB2020-08-24a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A213632-001DESONIDE0.05%LOTION / TOPICALAB2020-08-249b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A213632-001DESONIDE0.05%LOTION / TOPICALAB2020-08-24a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A213632-001DESONIDE0.05%LOTION / TOPICALAB2020-08-243f0d92c62455…
2023-05-13 08:27 UTC2023-05A213632-001DESONIDE0.05%LOTION / TOPICALAB2020-08-24053a50430f4f…
2023-01-26 05:58 UTC2023-01A213632-001DESONIDE0.05%LOTION / TOPICALAB2020-08-243bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A213632-001DESONIDE0.05%LOTION / TOPICALAB2020-08-243a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A213632-001DESONIDE0.05%LOTION / TOPICALAB2020-08-24f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A213632-001DESONIDE0.05%LOTION / TOPICALAB2020-08-24e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A213632-001DESONIDE0.05%LOTION / TOPICALAB2020-08-24cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213632-001DESONIDE0.05%LOTION / TOPICALABRS2020-08-24a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A213632-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213632-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213632-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213632-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213632-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213632-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213632-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213632-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213632-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213632-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213632-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213632-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213632-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213632-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213632-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213632-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A213632-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A213632-001AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A213632-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A213632-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A213632-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A213632-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A213632-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A213632-001AB1c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213632-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A213632-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A213632-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A213632-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A213632-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A213632-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A213632-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A213632-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A213632-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A213632-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A213632-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A213632-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A213632-001AB1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213632-001AB1a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DESONIDE.5 mg/mL

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
197572Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
90f27c9b-5c9e-4152-9ddf-659231ca993aAvailable 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
62332-550-18Desonide1 in 1 CARTONLOTION110
62332-550-18Desonide118 mL in 1 BOTTLELOTION11810
62332-550-59Desonide1 in 1 CARTONLOTION110
62332-550-59Desonide59 mL in 1 BOTTLELOTION5910

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-550DESONIDE LOTION [ALEMBIC PHARMACEUTICALS INC.]8Current NDC, Legacy NDC, 4 package rows20231216_90f27c9b-5c9e-4152-9ddf-659231ca993a.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.90f27c9b-5c9e-4152-9ddf-659231ca993a2026-01-23Adverse reactionsExact identifier
application applno (ANDA): 213632
application number: ANDA213632
ndc (product): 62332-550
DesonideDESONIDEAlembic Pharmaceuticals Limitedd210d307-72df-40fb-89c9-88663b0e49012025-03-26Adverse reactionsExact identifier
application applno (ANDA): 213632
application number: ANDA213632

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197572desonide 0.05 % Topical LotionPSN90f27c9b-5c9e-4152-9ddf-659231ca993a10
197572desonide 0.5 MG/ML Topical LotionSCD90f27c9b-5c9e-4152-9ddf-659231ca993a10
197572desonide 0.05 % Topical LotionSY90f27c9b-5c9e-4152-9ddf-659231ca993a10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62332-550-18623320550181 BOTTLE in 1 CARTON (62332-550-18) / 118 mL in 1 BOTTLE1 bottle2020-08-280000-00-00NoNoCurrent
62332-550-59623320550591 BOTTLE in 1 CARTON (62332-550-59) / 59 mL in 1 BOTTLE1 bottle2020-08-280000-00-00NoNoCurrent