Ertaczo

Product NDC
0187-5115
11-digit product format
001875115
Labeler code
0187
Product ID
0187-5115_c5d11596-8c13-483a-93f9-f7016fb8c663
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sertaconazole Nitrate
Dosage form
CREAM
Route
TOPICAL
Labeler
Bausch Health US, LLC
Application
NDA021385
Marketing category
NDA
Marketing start
2003-12-10
Marketing end
0000-00-00
Substance
SERTACONAZOLE NITRATE
Active strength
20 mg/g
Pharmacologic classes
Azole Antifungal [EPC],Azoles [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0187-5115-60GM - Gram0187-511595aeb7fc-8b86-412d-987f-0c0ffe444ccb12013-11-04

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0187-5115ERTACZO (SERTACONAZOLE NITRATE) CREAM [BAUSCH HEALTH US, LLC]14Legacy NDC20210507_821073f7-33f6-464d-baed-f66d97987d6d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0187-5115-60001875115601 TUBE in 1 CARTON (0187-5115-60) > 60 g in 1 TUBE1 tube2003-12-100000-00-00NoNoCurrent