CLOBETASOL PROPIONATE

Product NDC
46708-425
11-digit product format
467080425
Labeler code
46708
Product ID
46708-425_012b555d-9cbe-4db4-87f7-2b6500eb452e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CLOBETASOL PROPIONATE
Dosage form
SPRAY
Route
TOPICAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA211191
Marketing category
ANDA
Marketing start
2025-02-12
Substance
CLOBETASOL PROPIONATE
Active strength
.05 g/mL
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
46708-425-12467080425121 BOTTLE in 1 CARTON (46708-425-12) / 125 mL in 1 BOTTLE1 bottle2025-02-12NoNoHistorical
46708-425-59467080425591 BOTTLE in 1 CARTON (46708-425-59) / 59 mL in 1 BOTTLE1 bottle2025-02-12NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
CLOBETASOL PROPIONATEAlembic Pharmaceuticals Limited2025-02-10HUMAN PRESCRIPTION DRUG LABEL1