CLOBETASOL PROPIONATE

Product NDC
46708-547
11-digit product format
467080547
Labeler code
46708
Product ID
46708-547_99341bff-4fc2-4651-9e4f-448a2b9052b2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CLOBETASOL PROPIONATE
Dosage form
CREAM
Route
TOPICAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA213291
Marketing category
ANDA
Marketing start
2025-03-26
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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
779619577MCLOBETASOL PROPIONATE25122-46-7CLOBETASOL PROPIONATE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
46708-547-15467080547151 TUBE in 1 CARTON (46708-547-15) / 15 g in 1 TUBE1 tube2025-03-26NoNoHistorical
46708-547-30467080547301 TUBE in 1 CARTON (46708-547-30) / 30 g in 1 TUBE1 tube2025-03-26NoNoHistorical
46708-547-45467080547451 TUBE in 1 CARTON (46708-547-45) / 45 g in 1 TUBE1 tube2025-03-26NoNoHistorical
46708-547-60467080547601 TUBE in 1 CARTON (46708-547-60) / 60 g in 1 TUBE1 tube2025-03-26NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
CLOBETASOL PROPIONATEAlembic Pharmaceuticals Limited2025-03-26HUMAN PRESCRIPTION DRUG LABEL1