FDA.reportPublic FDA data

CLOBETASOL PROPIONATE

Product NDC
46708-486
11-digit product format
467080486
Labeler code
46708
Product ID
46708-486_39e082e7-ecec-458f-83fe-67edbf4c7bed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CLOBETASOL PROPIONATE
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA212881
Marketing category
ANDA
Marketing start
2025-03-17
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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
46708-486-25CLOBETASOL PROPIONATE1 in 1 CARTONSOLUTION11
46708-486-25CLOBETASOL PROPIONATE25 mL in 1 BOTTLESOLUTION251
46708-486-50CLOBETASOL PROPIONATE50 mL in 1 BOTTLESOLUTION501
46708-486-50CLOBETASOL PROPIONATE1 in 1 CARTONSOLUTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-486CLOBETASOL PROPIONATE SOLUTION [ALEMBIC PHARMACEUTICALS LIMITED]1Current NDC, 4 package rows20250321_46bda1db-c2eb-461a-bcd0-dfdb6c7f542d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861487clobetasol propionate 0.05 % Topical SolutionPSN46bda1db-c2eb-461a-bcd0-dfdb6c7f542d1
861487clobetasol propionate 0.5 MG/ML Topical SolutionSCD46bda1db-c2eb-461a-bcd0-dfdb6c7f542d1
861487clobetasol propionate 0.05 % Topical SolutionSY46bda1db-c2eb-461a-bcd0-dfdb6c7f542d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
46708-486-25467080486251 BOTTLE in 1 CARTON (46708-486-25) / 25 mL in 1 BOTTLE1 bottle2025-03-17NoNoCurrent
46708-486-50467080486501 BOTTLE in 1 CARTON (46708-486-50) / 50 mL in 1 BOTTLE1 bottle2025-03-17NoNoCurrent