TERBINAFINE HYDROCHLORIDE

Product NDC
61919-451
11-digit product format
619190451
Labeler code
61919
Product ID
61919-451_a6b8a6a6-f256-0ccf-e053-2995a90a7444
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TERBINAFINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
DirectRX
Application
ANDA077137
Marketing category
ANDA
Marketing start
2015-01-01
Marketing end
0000-00-00
Substance
TERBINAFINE HYDROCHLORIDE
Active strength
250 mg/1
Pharmacologic classes
Allylamine [CS],Allylamine Antifungal [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-451-30EA - Each61919-45111b83380-1ef7-4793-a15a-424b5743bbb212016-09-02
61919-451-90EA - Each61919-45121129b0f-7b87-4901-bc55-1d7037748eaa12016-09-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-451-306191904513030 TABLET in 1 BOTTLE (61919-451-30) 30 tablet2015-01-010000-00-00NoNoCurrent
61919-451-906191904519090 TABLET in 1 BOTTLE (61919-451-90) 90 tablet2015-01-010000-00-00NoNoCurrent