FDA.reportPublic FDA data

Clobetasol Propionate

Product NDC
50090-5079
11-digit product format
500905079
Labeler code
50090
Product ID
50090-5079_1b65247a-38ac-495b-8210-76d381467251
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clobetasol Propionate
Dosage form
CREAM
Route
TOPICAL
Labeler
A-S Medication Solutions
Application
ANDA210034
Marketing category
ANDA
Marketing start
2018-06-19
Substance
CLOBETASOL PROPIONATE
Active strength
.5 mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210034-001CLOBETASOL PROPIONATECLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-06-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A210034-001AB1

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
2026-08-01 22:54:322026-06A210034-001CLOBETASOL PROPIONATE0.05%CREAM / TOPICALAB12018-06-15a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A210034-001AB11a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clobetasol PropionateCLOBETASOL PROPIONATEBryant Ranch Prepack4990e4c7-78b3-4bc8-85d0-6d58f08121ff2025-11-04Adverse reactionsExact identifier
application applno (ANDA): 210034
application number: ANDA210034
Clobetasol PropionateCLOBETASOL PROPIONATEBryant Ranch Prepack9856b731-0676-405d-817c-de385cbd08a32025-09-30Adverse reactionsExact identifier
application applno (ANDA): 210034
application number: ANDA210034
Clobetasol PropionateCLOBETASOL PROPIONATEBryant Ranch Prepack643682ee-39c8-4a0d-b131-f30077e6e20a2025-09-03Adverse reactionsExact identifier
application applno (ANDA): 210034
application number: ANDA210034
Clobetasol PropionateCLOBETASOL PROPIONATEBryant Ranch Prepack21a63bc2-a42a-412c-8dd5-17e279f99f272025-09-03Adverse reactionsExact identifier
application applno (ANDA): 210034
application number: ANDA210034
Clobetasol PropionateCLOBETASOL PROPIONATEBryant Ranch Prepack6d14d269-bae6-493a-81ed-83f6a3aa0f4f2025-09-03Adverse reactionsExact identifier
application applno (ANDA): 210034
application number: ANDA210034
Clobetasol PropionateCLOBETASOL PROPIONATEXiromed, LLC2556987f-4b0f-8a83-5bf4-095d67a450b42025-08-12Adverse reactionsExact identifier
application applno (ANDA): 210034
application number: ANDA210034
Clobetasol PropionateCLOBETASOL PROPIONATEA-S Medication Solutions52bf5318-2487-4c7b-aa8d-e98f22cc61042023-07-27Adverse reactionsExact identifier
application applno (ANDA): 210034
application number: ANDA210034
ndc (product): 50090-5079

Additional Listing Data#

Finished product
Yes
Brand name base
Clobetasol Propionate
Listing expiration
2026-12-31

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
861495Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
52bf5318-2487-4c7b-aa8d-e98f22cc6104Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
20abe2c3-3e80-d2b2-39eb-3156e4af4799Product name320250124
45ad92f8-d116-4c0c-851c-2e740b7d8e6fProduct name120250122
42be0ad5-6fd7-4f1b-8108-6d9dd7d571dfProduct name720250107
3813b789-94b9-edd6-f010-6b926dd462e5Product name520230113
30eee8a1-850e-41ed-b5ab-761301aeab49Product name620221206
18e5b6f7-c414-b1f1-b684-17fdd02c215eProduct name420210927
1c87bbde-dd91-a122-db33-67ae814cb645Product name720210510
519b5875-7d7d-4aa6-9d3d-470fa1376595Product name420200227
98669154-3e9c-47da-8a2c-656ab71848beProduct name220180607
8d4f8539-436f-453b-8b76-5322d403fc8eProduct name120180131
837ac3c6-ee71-c5a6-6eba-c4065f37e9f5Product name220171010

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5079-0Clobetasol Propionate15 g in 1 TUBECREAM158
50090-5079-0Clobetasol Propionate1 in 1 CARTONCREAM18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5079-0GM - Gram50090-5079627a8afb-198b-49e6-a812-dd03d4e1b9d812022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5079CLOBETASOL PROPIONATE CREAM [A-S MEDICATION SOLUTIONS]8Current NDC, Legacy NDC, 2 package rows20230728_52bf5318-2487-4c7b-aa8d-e98f22cc6104.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861495clobetasol propionate 0.05 % Topical CreamPSN52bf5318-2487-4c7b-aa8d-e98f22cc61048
861495clobetasol propionate 0.5 MG/ML Topical CreamSCD52bf5318-2487-4c7b-aa8d-e98f22cc61048
861495clobetasol propionate 0.05 % Topical CreamSY52bf5318-2487-4c7b-aa8d-e98f22cc61048

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5079-0500905079001 TUBE in 1 CARTON (50090-5079-0) / 15 g in 1 TUBE1 tube2020-06-170000-00-00NoNoCurrent