Terbinafine Hydrochloride

Product NDC
63187-213
11-digit product format
631870213
Labeler code
63187
Product ID
63187-213_c77565cf-daac-4bd2-98e8-569c96c0f4e5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Terbinafine
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA077533
Marketing category
ANDA
Marketing start
2011-01-01
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-213-306318702133030 TABLET in 1 BOTTLE (63187-213-30) 30 tablet2015-09-010000-00-00NoNoCurrent
63187-213-456318702134545 TABLET in 1 BOTTLE (63187-213-45) 45 tablet2015-09-010000-00-00NoNoCurrent
63187-213-606318702136060 TABLET in 1 BOTTLE (63187-213-60) 60 tablet2015-09-010000-00-00NoNoCurrent
63187-213-906318702139090 TABLET in 1 BOTTLE (63187-213-90) 90 tablet2015-09-010000-00-00NoNoCurrent