FDA.reportPublic FDA data

Clobetasol Propionate

Product NDC
50090-3085
11-digit product format
500903085
Labeler code
50090
Product ID
50090-3085_14dd3d8d-43a8-4202-853f-73da135c7ef8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clobetasol Propionate
Dosage form
SOLUTION
Route
TOPICAL
Labeler
A-S Medication Solutions
Application
ANDA074331
Marketing category
ANDA
Marketing start
2015-05-29
Marketing end
0000-00-00
Substance
CLOBETASOL PROPIONATE
Active strength
1 mg/mL
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
50090-3085-02020-01-31C16284748780-19d75b9cf-cedb-f424-e053-dadaa90a57ceCLOBETASOL PROPIONATE TOPICAL SOLUTION USP, 0.05% Rx Only FOR TOPICAL DERMATOLOGIC USE ONLY NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3085-0Clobetasol Propionate1 in 1 CARTONSOLUTION12
50090-3085-0Clobetasol Propionate50 mL in 1 BOTTLESOLUTION502

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3085-0ML - Milliliter50090-3085b55e5b72-5cdb-4b63-b2f8-fd84836ecbc712019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3085CLOBETASOL PROPIONATE (CLOBETASOL PROPIONATE) SOLUTION [A-S MEDICATION SOLUTIONS]2Legacy NDC, 2 package rows20180615_22fd9e1b-ba73-4a0e-a534-889837aa732d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861487clobetasol propionate 0.05 % Topical SolutionPSN22fd9e1b-ba73-4a0e-a534-889837aa732d2
861487clobetasol propionate 0.5 MG/ML Topical SolutionSCD22fd9e1b-ba73-4a0e-a534-889837aa732d2
861487clobetasol propionate 0.05 % Topical SolutionSY22fd9e1b-ba73-4a0e-a534-889837aa732d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50090-3085-0500903085001 in 1 CARTONHistorical