FDA.reportPublic FDA data

Clobetasol Propionate

Product NDC
50090-8001
11-digit product format
500908001
Labeler code
50090
Product ID
50090-8001_0a97beb9-db7c-4b93-be12-d9f8ec3ef810
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clobetasol Propionate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
A-S Medication Solutions
Application
ANDA215990
Marketing category
ANDA
Marketing start
2026-02-01
Substance
CLOBETASOL PROPIONATE
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 43.

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
A215990-001CLOBETASOL PROPIONATECLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2023-12-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A215990-001AB

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
2026-09-14 22:38:342026-08A215990-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2023-12-2884e616aacf4f…
2026-08-18 06:07:402026-07A215990-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2023-12-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A215990-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2023-12-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215990-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2023-12-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A215990-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2023-12-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215990-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2023-12-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215990-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2023-12-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215990-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2023-12-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215990-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2023-12-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215990-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2023-12-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215990-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2023-12-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215990-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2023-12-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215990-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2023-12-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215990-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2023-12-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215990-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2023-12-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A215990-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2023-12-288072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A215990-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2023-12-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A215990-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2023-12-281c564ffb4f44…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215990-001CLOBETASOL PROPIONATE0.05%OINTMENT / TOPICALAB2023-12-28a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A215990-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A215990-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A215990-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215990-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A215990-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215990-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215990-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215990-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215990-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215990-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215990-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215990-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215990-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215990-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215990-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A215990-001AB18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A215990-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A215990-001AB11c564ffb4f44…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215990-001AB1a50c72e98297…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOBETASOL PROPIONATE.5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
779619577MInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
861448Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8da21ad7-4d2d-4168-82ee-ebf13ce5e923Available on FDA.report

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clobetasol PropionateCLOBETASOL PROPIONATEA-S Medication Solutions8da21ad7-4d2d-4168-82ee-ebf13ce5e9232026-06-23Adverse reactionsExact identifier
application applno (ANDA): 215990
application number: ANDA215990
ndc (product): 50090-8001
Clobetasol PropionateCLOBETASOL PROPIONATENorthStar RxLLC3d14fff7-f1af-4d15-96b4-88cfccad271f2026-02-11Adverse reactionsExact identifier
application applno (ANDA): 215990
application number: ANDA215990
Clobetasol Propionate ANDACLOBETASOL PROPIONATEMacleods Pharmaceuticals Limited92cf4231-e301-4353-98d9-85206ec6ba962024-01-05Adverse reactionsExact identifier
application applno (ANDA): 215990
application number: ANDA215990

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-8001-0500908001001 TUBE in 1 CARTON (50090-8001-0) / 30 g in 1 TUBE1 tube2026-06-18NoNoCurrent