FDA.reportPublic FDA data

Clobetasol Propionate

Product NDC
52565-055
11-digit product format
525650055
Labeler code
52565
Product ID
52565-055_4533cb56-c0eb-4541-885c-001b4f8bc9e9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clobetasol Propionate
Dosage form
LOTION
Route
TOPICAL
Labeler
Teligent Pharma, Inc.
Application
ANDA208667
Marketing category
ANDA
Marketing start
2016-11-29
Marketing end
0000-00-00
Substance
CLOBETASOL PROPIONATE
Active strength
0 mg/100mL
Pharmacologic classes
Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
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
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
52565-055-022023-01-30C16284748780-1f386c64a-0019-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CLOBETASOL PROPIONATE lotion safely and effectively. See full prescribing information for CLOBETASOL PROPIONATE lotion. CLOBETASOL PROPIONATE lotion, for topical use. Initial U.S. Approval: 1985
52565-055-042023-01-30C16284748780-1f386c64a-0019-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CLOBETASOL PROPIONATE lotion safely and effectively. See full prescribing information for CLOBETASOL PROPIONATE lotion. CLOBETASOL PROPIONATE lotion, for topical use. Initial U.S. Approval: 1985

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52565-055-02Clobetasol Propionate59 mL in 1 BOTTLELOTION592
52565-055-02Clobetasol Propionate1 in 1 CARTONLOTION12
52565-055-04Clobetasol Propionate118 mL in 1 BOTTLELOTION1182
52565-055-04Clobetasol Propionate1 in 1 CARTONLOTION12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52565-055-02ML - Milliliter52565-05516928129-1f09-471c-b7a8-266658f6a0f712017-03-06
52565-055-04ML - Milliliter52565-055ab0d937b-0b74-4753-8b98-1c462db85aa212017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52565-055CLOBETASOL PROPIONATE (CLOBETASOL PROPIONATE) LOTION [TELIGENT PHARMA, INC.]2Legacy NDC, 4 package rows20190911_a12c2b51-710d-68cd-2531-1c28f9864d8f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52565-055-02525650055021 BOTTLE in 1 CARTON (52565-055-02) > 59 mL in 1 BOTTLE1 bottle2016-11-290000-00-00NoNoCurrent
52565-055-04525650055041 BOTTLE in 1 CARTON (52565-055-04) > 118 mL in 1 BOTTLE1 bottle2016-11-290000-00-00NoNoCurrent