Terbinafine Hydrochloride

Product NDC
63187-792
11-digit product format
631870792
Labeler code
63187
Product ID
63187-792_1d3fd7ce-1ee9-413f-9c5d-73e9864327f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Terbinafine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA077137
Marketing category
ANDA
Marketing start
2014-08-13
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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-792-30EA - Each63187-7922042d079-3efa-48a0-a497-0efab47ce5bd12017-03-06
63187-792-35EA - Each63187-792dff5ea58-5bf5-40d9-9964-b8dfbbbd218512017-10-13
63187-792-45EA - Each63187-7926e2bb92c-1452-4dab-bf69-dbeae1a3788312017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-792TERBINAFINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]4Legacy NDC20191115_89220c91-78bc-416f-b40a-af5fadc2ea6c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-792-306318707923030 TABLET in 1 BOTTLE (63187-792-30) 30 tablet2017-01-020000-00-00NoNoCurrent
63187-792-356318707923535 TABLET in 1 BOTTLE (63187-792-35) 35 tablet2017-08-010000-00-00NoNoCurrent
63187-792-456318707924545 TABLET in 1 BOTTLE (63187-792-45) 45 tablet2017-07-030000-00-00NoNoCurrent
63187-792-606318707926060 TABLET in 1 BOTTLE (63187-792-60) 60 tablet2017-01-020000-00-00NoNoCurrent
63187-792-906318707929090 TABLET in 1 BOTTLE (63187-792-90) 90 tablet2017-01-020000-00-00NoNoCurrent