Terbinafine Hydrochloride

Product NDC
68788-9094
11-digit product format
687889094
Labeler code
68788
Product ID
68788-9094_5831d093-9a92-43c2-a384-1ba1537dbcf7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Terbinafine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc
Application
ANDA077919
Marketing category
ANDA
Marketing start
2011-06-29
Marketing end
0000-00-00
Substance
TERBINAFINE HYDROCHLORIDE
Active strength
250 mg/1
Pharmacologic classes
Allylamine [CS],Allylamine Antifungal [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68788-9094-32020-12-10C16284748780-1960f7f55-c581-8e05-e053-dbdaa90a074a5831d093-9a92-43c2-a384-1ba1537dbcf7
68788-9094-32019-10-29C16284748780-1960f7f55-c581-8e05-e053-dbdaa90a074a5831d093-9a92-43c2-a384-1ba1537dbcf7