FDA.reportPublic FDA data

clobetasol propionate

Product NDC
43386-028
11-digit product format
433860028
Labeler code
43386
Product ID
43386-028_e54a7d86-dbf1-476b-bd27-a1853d3e74d7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clobetasol propionate
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Lupin Pharmaceuticals,Inc.
Application
ANDA206075
Marketing category
ANDA
Marketing start
2015-11-23
Substance
CLOBETASOL PROPIONATE
Active strength
.5 mg/mL
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
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii779619577M
Rxcui861487

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
43386-028-60clobetasol propionate1 in 1 CARTONSOLUTION13
43386-028-60clobetasol propionate50 mL in 1 BOTTLESOLUTION503
43386-028-61clobetasol propionate25 mL in 1 BOTTLESOLUTION253
43386-028-61clobetasol propionate1 in 1 CARTONSOLUTION13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43386-028-60ML - Milliliter43386-02879774ee6-dd1c-46c4-8781-7a6ebb5ec5ca12017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43386-028CLOBETASOL PROPIONATE SOLUTION [LUPIN PHARMACEUTICALS,INC.]3Current NDC, Legacy NDC, 4 package rows20240201_c6efb5f3-3532-4742-a359-3991bb76338f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861487clobetasol propionate 0.05 % Topical SolutionPSNc6efb5f3-3532-4742-a359-3991bb76338f3
861487clobetasol propionate 0.5 MG/ML Topical SolutionSCDc6efb5f3-3532-4742-a359-3991bb76338f3
861487clobetasol propionate 0.05 % Topical SolutionSYc6efb5f3-3532-4742-a359-3991bb76338f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43386-028-60433860028601 BOTTLE in 1 CARTON (43386-028-60) / 50 mL in 1 BOTTLE1 bottle2015-11-230000-00-00NoNoCurrent
43386-028-61433860028611 BOTTLE in 1 CARTON (43386-028-61) > 25 mL in 1 BOTTLE1 bottle2017-10-260000-00-00NoNoCurrent