FDA.reportPublic FDA data

Clobetasol Propionate

Product NDC
50090-0548
11-digit product format
500900548
Labeler code
50090
Product ID
50090-0548_ca603de5-34d8-4f6b-963e-d78d74f4a978
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clobetasol Propionate
Dosage form
CREAM
Route
TOPICAL
Labeler
A-S Medication Solutions
Application
ANDA074220
Marketing category
ANDA
Marketing start
2010-06-07
Marketing end
0000-00-00
Substance
CLOBETASOL PROPIONATE
Active strength
1 mg/g
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50090-0548IInactivated by FDA2026-07-31
excluded packagepackage50090-054850090-0548-0IInactivated by FDA2026-07-31

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
A074220-001CORMAXCLOBETASOL PROPIONATE0.05%CREAM / TOPICAL1997-05-16

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 22:54:322026-06A074220-001CORMAX0.05%CREAM / TOPICAL1997-05-16a50c72e98297…

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-0548-02023-01-30C16284748780-1f386c649-b0b2-0266-e053-dadaa90a7c1aClobetasol Propionate Cream, USP, 0.05% Clobetasol Propionate Ointment, USP, 0.05%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0548-0Clobetasol Propionate1 in 1 CARTONCREAM15
50090-0548-0Clobetasol Propionate15 g in 1 TUBECREAM155

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0548-0GM - Gram50090-05486c276cee-3b8e-441e-bd84-2c715631943e12021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0548CLOBETASOL PROPIONATE CREAM [A-S MEDICATION SOLUTIONS]5Legacy NDC, 2 package rows20210416_954dee1c-8667-462a-a7bb-a32b0f4c2624.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861495clobetasol propionate 0.05 % Topical CreamPSN954dee1c-8667-462a-a7bb-a32b0f4c26245
861495clobetasol propionate 0.5 MG/ML Topical CreamSCD954dee1c-8667-462a-a7bb-a32b0f4c26245
861495clobetasol propionate 0.05 % Topical CreamSY954dee1c-8667-462a-a7bb-a32b0f4c26245

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0548-0500900548001 TUBE in 1 CARTON (50090-0548-0) > 15 g in 1 TUBE1 tube2014-11-280000-00-00NoNoCurrent