Clobetasol Propionate

Product NDC
33342-321
11-digit product format
333420321
Labeler code
33342
Product ID
33342-321_7b4cca50-7139-4d48-8f4a-f8204fc46b2e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clobetasol Propionate
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA209361
Marketing category
ANDA
Marketing start
2017-11-04
Substance
CLOBETASOL PROPIONATE
Active strength
.4625 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.4625 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii779619577M

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
33342-321-39Clobetasol Propionate1 in 1 CARTONSOLUTION13
33342-321-39Clobetasol Propionate25 mL in 1 BOTTLESOLUTION253
33342-321-86Clobetasol Propionate1 in 1 CARTONSOLUTION13
33342-321-86Clobetasol Propionate50 mL in 1 BOTTLESOLUTION503

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-321-86ML - Milliliter33342-321fd80630f-f234-4e24-a600-d5b85eff539d12018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-321CLOBETASOL PROPIONATE SOLUTION [MACLEODS PHARMACEUTICALS LIMITED]3Current NDC, Legacy NDC, 4 package rows20231216_5ad9c808-6095-4d86-b140-e0f6d4079a3a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
33342-321-39333420321391 BOTTLE in 1 CARTON (33342-321-39) / 25 mL in 1 BOTTLE1 bottle2021-10-080000-00-00NoNoCurrent
33342-321-86333420321861 BOTTLE in 1 CARTON (33342-321-86) / 50 mL in 1 BOTTLE1 bottle2017-11-040000-00-00NoNoCurrent