Clotrimazole and Betamethasone Dipropionate

Product NDC
80425-0344
11-digit product format
804250344
Labeler code
80425
Product ID
80425-0344_2a9bfe6a-6d75-b262-e063-6294a90a1cf3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clotrimazole and Betamethasone Dipropionate
Dosage form
CREAM
Route
TOPICAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA075673
Marketing category
ANDA
Marketing start
2023-06-15
Substance
BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE
Active strength
.5; 10 mg/g; mg/g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS], 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
826Y60901UBETAMETHASONE DIPROPIONATE5593-20-4BETAMETHASONE DIPROPIONATE
G07GZ97H65CLOTRIMAZOLE23593-75-1CLOTRIMAZOLE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0344-1804250344011 TUBE in 1 CARTON (80425-0344-1) / 15 g in 1 TUBE1 tube2023-06-15NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Clotrimazole and Betamethasone Dipropionate CreamAdvanced Rx Pharmacy of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL2