FDA.reportPublic FDA data

Terbinafine

Product NDC
71205-492
11-digit product format
712050492
Labeler code
71205
Product ID
71205-492_bfd48470-04e9-46cb-857b-10d014b5ae1f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Terbinafine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA078297
Marketing category
ANDA
Marketing start
2007-07-02
Substance
TERBINAFINE HYDROCHLORIDE
Active strength
250 mg/1
Pharmacologic classes
Allylamine Antifungal [EPC], Allylamine [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Terbinafine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TERBINAFINE HYDROCHLORIDE250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii012C11ZU6G
Rxcui313222

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
55a24767-1759-5f6a-8888-ea4aa0adac21Product name120140508
db9701af-cb4f-b8ba-d282-6bc5b6b7c467Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-492-30Terbinafine30 in 1 BOTTLETABLET305
71205-492-35Terbinafine35 in 1 BOTTLETABLET355
71205-492-42Terbinafine42 in 1 BOTTLETABLET425
71205-492-45Terbinafine45 in 1 BOTTLETABLET455
71205-492-60Terbinafine60 in 1 BOTTLETABLET605
71205-492-90Terbinafine90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-492-42EA - Each71205-49248e052a7-317b-4bed-bd33-fa241fbfe53812024-06-10
71205-492-45EA - Each71205-4925fc895ca-eece-408c-81dc-36fb0e7184c312022-06-06
71205-492-90EA - Each71205-49274db4b8c-7be3-4205-a689-1122dbcc5af312022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-492TERBINAFINE (TERBINAFINE HYDROCHLORIDE) TABLET [PROFICIENT RX LP]5Current NDC, Legacy NDC, 6 package rows20240407_50657431-1cd9-42dd-9cfc-57db8713d267.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313222terbinafine HCl 250 MG Oral TabletPSN50657431-1cd9-42dd-9cfc-57db8713d2675
313222terbinafine 250 MG Oral TabletSCD50657431-1cd9-42dd-9cfc-57db8713d2675
313222terbinafine (as terbinafine HCl) 250 MG Oral TabletSY50657431-1cd9-42dd-9cfc-57db8713d2675

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-492-307120504923030 TABLET in 1 BOTTLE (71205-492-30) 30 tablet2020-10-160000-00-00NoNoCurrent
71205-492-357120504923535 TABLET in 1 BOTTLE (71205-492-35) 35 tablet2023-03-09NoNoHistorical
71205-492-427120504924242 TABLET in 1 BOTTLE (71205-492-42) 42 tablet2024-04-01NoNoHistorical
71205-492-457120504924545 TABLET in 1 BOTTLE (71205-492-45) 45 tablet2022-03-160000-00-00NoNoCurrent
71205-492-607120504926060 TABLET in 1 BOTTLE (71205-492-60) 60 tablet2020-10-160000-00-00NoNoCurrent
71205-492-907120504929090 TABLET in 1 BOTTLE (71205-492-90) 90 tablet2020-10-160000-00-00NoNoCurrent