Terbinafine Hydrochloride

Product NDC
68788-7187
11-digit product format
687887187
Labeler code
68788
Product ID
68788-7187_9b44cd6d-a812-4d66-8097-91033c9124c1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Terbinafine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA077714
Marketing category
ANDA
Marketing start
2018-07-17
Marketing end
0000-00-00
Substance
TERBINAFINE HYDROCHLORIDE
Active strength
250 mg/1
Pharmacologic classes
Allylamine Antifungal [EPC], Allylamine [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7187-3EA - Each68788-718702e7ea57-9769-4475-bf70-7530523ef71812018-09-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7187-36878871870330 TABLET in 1 BOTTLE (68788-7187-3) 30 tablet2018-07-170000-00-00NoNoCurrent