FDA.reportPublic FDA data

Clobetasol Propionate Cream USP, 0.05%

Product NDC
21922-016
11-digit product format
219220016
Labeler code
21922
Product ID
21922-016_03d5cd0f-1991-440f-9942-6a140f762b6b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clobetasol Propionate Cream USP, 0.05%
Dosage form
CREAM
Route
TOPICAL
Labeler
Encube Ethicals, Inc.
Application
ANDA212982
Marketing category
ANDA
Marketing start
2020-10-01
Substance
CLOBETASOL PROPIONATE
Active strength
.5 mg/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Clobetasol Propionate Cream USP, 0.05%
Brand name suffix
Clobetasol Propionate Cream USP, 0.05%
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOBETASOL PROPIONATE.5 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii779619577M
Rxcui861495

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21922-016-04Clobetasol Propionate Cream USP, 0.05%Clobetasol Propionate Cream USP, 0.05%15 g in 1 TUBECREAM154
21922-016-05Clobetasol Propionate Cream USP, 0.05%Clobetasol Propionate Cream USP, 0.05%30 g in 1 TUBECREAM304
21922-016-06Clobetasol Propionate Cream USP, 0.05%Clobetasol Propionate Cream USP, 0.05%45 g in 1 TUBECREAM454
21922-016-07Clobetasol Propionate Cream USP, 0.05%Clobetasol Propionate Cream USP, 0.05%60 g in 1 TUBECREAM604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21922-016CLOBETASOL PROPIONATE CREAM USP, 0.05% CLOBETASOL PROPIONATE CREAM USP, 0.05% (CLOBETASOL PROPIONATE CREAM USP, 0.05%) CREAM [ENCUBE ETHICALS PRIVATE LIMITED]3Current NDC, Legacy NDC, 4 package rows20241017_bcb76b4b-194d-4cb3-b3ed-26b911df1a11.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861495clobetasol propionate 0.05 % Topical CreamPSN29113d5e-1570-4fc5-9ce6-a00230e4377e104
861495clobetasol propionate 0.5 MG/ML Topical CreamSCD29113d5e-1570-4fc5-9ce6-a00230e4377e104
861495clobetasol propionate 0.05 % Topical CreamSY29113d5e-1570-4fc5-9ce6-a00230e4377e104
861495clobetasol propionate 0.05 % Topical CreamPSNe9af15cc-7795-44e8-b294-057630981824100
861495clobetasol propionate 0.5 MG/ML Topical CreamSCDe9af15cc-7795-44e8-b294-057630981824100
861495clobetasol propionate 0.05 % Topical CreamSYe9af15cc-7795-44e8-b294-057630981824100
861495clobetasol propionate 0.05 % Topical CreamPSN98b23b99-fab4-49fb-b070-758fb030e9bb6
861495clobetasol propionate 0.5 MG/ML Topical CreamSCD98b23b99-fab4-49fb-b070-758fb030e9bb6
861495clobetasol propionate 0.05 % Topical CreamSY98b23b99-fab4-49fb-b070-758fb030e9bb6
861495clobetasol propionate 0.05 % Topical CreamPSNbcb76b4b-194d-4cb3-b3ed-26b911df1a114
861495clobetasol propionate 0.5 MG/ML Topical CreamSCDbcb76b4b-194d-4cb3-b3ed-26b911df1a114
861495clobetasol propionate 0.05 % Topical CreamSYbcb76b4b-194d-4cb3-b3ed-26b911df1a114
861495clobetasol propionate 0.05 % Topical CreamPSN61f63eec-ecf3-4979-adab-f26eb8f29d653
861495clobetasol propionate 0.05 % Topical CreamPSNd40ea303-9eba-4750-955d-6bb005882fb53
861495clobetasol propionate 0.5 MG/ML Topical CreamSCD61f63eec-ecf3-4979-adab-f26eb8f29d653
861495clobetasol propionate 0.5 MG/ML Topical CreamSCDd40ea303-9eba-4750-955d-6bb005882fb53
861495clobetasol propionate 0.05 % Topical CreamSY61f63eec-ecf3-4979-adab-f26eb8f29d653
861495clobetasol propionate 0.05 % Topical CreamSYd40ea303-9eba-4750-955d-6bb005882fb53
861495clobetasol propionate 0.05 % Topical CreamPSNdbfe408a-ceb1-241a-e053-2a95a90a4d902
861495clobetasol propionate 0.05 % Topical CreamPSNcc716dab-b535-8b51-e053-2995a90a8f162
861495clobetasol propionate 0.5 MG/ML Topical CreamSCDdbfe408a-ceb1-241a-e053-2a95a90a4d902
861495clobetasol propionate 0.5 MG/ML Topical CreamSCDcc716dab-b535-8b51-e053-2995a90a8f162
861495clobetasol propionate 0.05 % Topical CreamSYdbfe408a-ceb1-241a-e053-2a95a90a4d902
861495clobetasol propionate 0.05 % Topical CreamSYcc716dab-b535-8b51-e053-2995a90a8f162
861495clobetasol propionate 0.05 % Topical CreamPSN6f52ac0f-4028-4733-9ef6-e5ce5468b3841
861495clobetasol propionate 0.05 % Topical CreamPSN1917a2a1-1591-4383-8466-ae12988b209f1
861495clobetasol propionate 0.05 % Topical CreamPSNbf8d2ec8-cc35-2dfd-e053-2995a90aa0bb1
861495clobetasol propionate 0.5 MG/ML Topical CreamSCDbf8d2ec8-cc35-2dfd-e053-2995a90aa0bb1
861495clobetasol propionate 0.5 MG/ML Topical CreamSCD6f52ac0f-4028-4733-9ef6-e5ce5468b3841
861495clobetasol propionate 0.5 MG/ML Topical CreamSCD1917a2a1-1591-4383-8466-ae12988b209f1
861495clobetasol propionate 0.05 % Topical CreamSYbf8d2ec8-cc35-2dfd-e053-2995a90aa0bb1
861495clobetasol propionate 0.05 % Topical CreamSY1917a2a1-1591-4383-8466-ae12988b209f1
861495clobetasol propionate 0.05 % Topical CreamSY6f52ac0f-4028-4733-9ef6-e5ce5468b3841

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21922-016-042192200160415 g in 1 TUBE (21922-016-04) 15 g2020-10-010000-00-00NoNoCurrent
21922-016-052192200160530 g in 1 TUBE (21922-016-05) 30 g2020-10-010000-00-00NoNoCurrent
21922-016-062192200160645 g in 1 TUBE (21922-016-06) 45 g2020-10-010000-00-00NoNoCurrent
21922-016-072192200160760 g in 1 TUBE (21922-016-07) 60 g2020-10-010000-00-00NoNoCurrent