FDA.reportPublic FDA data

Clobetasol Propionate

Product NDC
50090-4647
Requested package NDC
50090-4647-0
11-digit product format
500904647
Labeler code
50090
Product ID
50090-4647_c12633e3-9404-4903-ae09-f0383c4dd214
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clobetasol Propionate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
A-S Medication Solutions
Application
ANDA074221
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50090-464750090-4647-0IInactivated 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
A074221-001EMBELINECLOBETASOL PROPIONATE0.05%OINTMENT / TOPICAL1995-03-31

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 22:54:322026-06A074221-001EMBELINE0.05%OINTMENT / TOPICAL1995-03-31a50c72e98297…

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
50090-4647-02023-01-30C16284748780-1f386c649-ab2b-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
50090-4647-0Clobetasol Propionate30 g in 1 TUBEOINTMENT3011
50090-4647-0Clobetasol Propionate1 in 1 CARTONOINTMENT111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4647-0GM - Gram50090-46479dd3bcb7-de3e-4919-95f7-a5bd02ac3c1512022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4647CLOBETASOL PROPIONATE OINTMENT [A-S MEDICATION SOLUTIONS]11Legacy NDC, 2 package rows20210417_6e4dd0cf-b5f8-406c-8c4a-d8a3ac50b1ce.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861448clobetasol propionate 0.05 % Topical OintmentPSN6e4dd0cf-b5f8-406c-8c4a-d8a3ac50b1ce11
861448clobetasol propionate 0.0005 MG/MG Topical OintmentSCD6e4dd0cf-b5f8-406c-8c4a-d8a3ac50b1ce11
861448clobetasol propionate 0.05 % Topical OintmentSY6e4dd0cf-b5f8-406c-8c4a-d8a3ac50b1ce11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4647-0500904647001 TUBE in 1 CARTON (50090-4647-0) > 30 g in 1 TUBE1 tube2019-10-240000-00-00NoNoCurrent