FDA.reportPublic FDA data

CLOBETASOL PROPIONATE

Product NDC
46708-707
11-digit product format
467080707
Labeler code
46708
Product ID
46708-707_982087a2-6263-4470-9bef-a467b25f0fe4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CLOBETASOL PROPIONATE
Dosage form
AEROSOL, FOAM
Route
TOPICAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA215838
Marketing category
ANDA
Marketing start
2025-04-25
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
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii779619577M
Rxcui861353

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
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
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
46708-707-31CLOBETASOL PROPIONATE1 in 1 CARTONAEROSOL, FOAM11
46708-707-31CLOBETASOL PROPIONATE100 g in 1 CANAEROSOL, FOAM1001
46708-707-50CLOBETASOL PROPIONATE1 in 1 CARTONAEROSOL, FOAM11
46708-707-50CLOBETASOL PROPIONATE50 g in 1 CANAEROSOL, FOAM501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-707CLOBETASOL PROPIONATE AEROSOL, FOAM [ALEMBIC PHARMACEUTICALS LIMITED]1Current NDC, 4 package rows20250427_6fc0d1ac-f357-4038-8004-263bfaed4eaf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861353clobetasol propionate 0.05 % Topical FoamPSN6fc0d1ac-f357-4038-8004-263bfaed4eaf1
861353clobetasol propionate 0.5 MG/ML Topical FoamSCD6fc0d1ac-f357-4038-8004-263bfaed4eaf1
861353clobetasol propionate 0.05 % Topical FoamSY6fc0d1ac-f357-4038-8004-263bfaed4eaf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
46708-707-31467080707311 CAN in 1 CARTON (46708-707-31) / 100 g in 1 CAN1 can2025-04-25NoNoCurrent
46708-707-50467080707501 CAN in 1 CARTON (46708-707-50) / 50 g in 1 CAN1 can2025-04-25NoNoCurrent