Clobetasol Propionate

Product NDC
50383-978
11-digit product format
503830978
Labeler code
50383
Product ID
50383-978_ba0e75dd-33b5-40b8-97d0-0194fed2bc99
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clobetasol Propionate
Dosage form
LOTION
Route
TOPICAL
Labeler
Akorn
Application
ANDA211348
Marketing category
ANDA
Marketing start
2018-11-05
Marketing end
0000-00-00
Substance
CLOBETASOL PROPIONATE
Active strength
0 g/100mL
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50383-978-02Clobetasol Propionate1 in 1 CARTONLOTION16
50383-978-02Clobetasol Propionate59 mL in 1 BOTTLELOTION596
50383-978-04Clobetasol Propionate1 in 1 CARTONLOTION16
50383-978-04Clobetasol Propionate118 mL in 1 BOTTLELOTION1186

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50383-978CLOBETASOL PROPIONATE LOTION [AKORN]6Legacy NDC, 4 package rows20221111_31c443c8-3cb8-4250-93f3-4ae2b4659f0b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861505clobetasol propionate 0.05 % Topical LotionPSN31c443c8-3cb8-4250-93f3-4ae2b4659f0b6
861505clobetasol propionate 0.5 MG/ML Topical LotionSCD31c443c8-3cb8-4250-93f3-4ae2b4659f0b6
861505clobetasol propionate 0.05 % Topical LotionSY31c443c8-3cb8-4250-93f3-4ae2b4659f0b6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50383-978-02503830978021 BOTTLE in 1 CARTON (50383-978-02) > 59 mL in 1 BOTTLE1 bottle2018-11-050000-00-00NoNoCurrent
50383-978-04503830978041 BOTTLE in 1 CARTON (50383-978-04) > 118 mL in 1 BOTTLE1 bottle2018-11-050000-00-00NoNoCurrent