MENTAX

Product NDC
0378-6151
11-digit product format
003786151
Labeler code
0378
Product ID
0378-6151_b476a527-ae8d-4d01-80d5-9962879d5a8a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
butenafine hydrochloride
Dosage form
CREAM
Route
TOPICAL
Labeler
Mylan Pharmaceuticals Inc.
Application
NDA020524
Marketing category
NDA
Marketing start
1996-12-31
Marketing end
2023-07-31
Substance
BUTENAFINE HYDROCHLORIDE
Active strength
10 mg/g
Pharmacologic classes
Benzylamine Antifungal [EPC], Benzylamines [CS]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-6151-46GM - Gram0378-6151df1c20b5-1ba2-4966-b3af-7c1962ac3b7112012-07-24
0378-6151-49GM - Gram0378-6151bdb670cc-e5e5-4582-afbe-f075ccb9bcfb12012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-6151-46003786151461 TUBE in 1 CARTON (0378-6151-46) > 15 g in 1 TUBE1 tube1996-12-310000-00-00NoNoCurrent
0378-6151-49003786151491 TUBE in 1 CARTON (0378-6151-49) > 30 g in 1 TUBE1 tube1996-12-310000-00-00NoNoCurrent