FDA.reportPublic FDA data

terbinafine hydrochloride

Product NDC
69452-351
11-digit product format
694520351
Labeler code
69452
Product ID
69452-351_233cb04d-09cc-4312-923f-f4666bdf9754
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
terbinafine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bionpharma Inc.
Application
ANDA078163
Marketing category
ANDA
Marketing start
2022-01-28
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 hydrochloride
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
69452-351-13terbinafine hydrochloride30 in 1 BOTTLE, PLASTICTABLET303
69452-351-20terbinafine hydrochloride100 in 1 BOTTLE, PLASTICTABLET1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69452-351-13EA - Each69452-351ce0630f4-76e4-4fa9-9f93-ebc2d03ba16212022-06-06
69452-351-20EA - Each69452-351317ead21-4e73-42cd-aeba-2b781251f1c712023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69452-351TERBINAFINE HYDROCHLORIDE TABLET [BIONPHARMA INC.]3Current NDC, Legacy NDC, 2 package rows20241220_34221c17-0d8c-4b56-8af3-c74efab4599e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313222terbinafine HCl 250 MG Oral TabletPSN5a921005-304e-4f5b-b9ba-681749e2499b104
313222terbinafine 250 MG Oral TabletSCD5a921005-304e-4f5b-b9ba-681749e2499b104
313222terbinafine (as terbinafine HCl) 250 MG Oral TabletSY5a921005-304e-4f5b-b9ba-681749e2499b104
313222terbinafine HCl 250 MG Oral TabletPSN2886b2ff-815f-4621-bc28-1fea082c19206
313222terbinafine 250 MG Oral TabletSCD2886b2ff-815f-4621-bc28-1fea082c19206
313222terbinafine (as terbinafine HCl) 250 MG Oral TabletSY2886b2ff-815f-4621-bc28-1fea082c19206
313222terbinafine HCl 250 MG Oral TabletPSN34221c17-0d8c-4b56-8af3-c74efab4599e3
313222terbinafine 250 MG Oral TabletSCD34221c17-0d8c-4b56-8af3-c74efab4599e3
313222terbinafine (as terbinafine HCl) 250 MG Oral TabletSY34221c17-0d8c-4b56-8af3-c74efab4599e3
313222terbinafine HCl 250 MG Oral TabletPSN53235270-6ffb-44c8-aa55-debf59e1d9642
313222terbinafine 250 MG Oral TabletSCD53235270-6ffb-44c8-aa55-debf59e1d9642
313222terbinafine (as terbinafine HCl) 250 MG Oral TabletSY53235270-6ffb-44c8-aa55-debf59e1d9642
313222terbinafine HCl 250 MG Oral TabletPSN8f6d7b1a-5a01-4cc5-b5b7-c126ae8895571
313222terbinafine 250 MG Oral TabletSCD8f6d7b1a-5a01-4cc5-b5b7-c126ae8895571
313222terbinafine (as terbinafine HCl) 250 MG Oral TabletSY8f6d7b1a-5a01-4cc5-b5b7-c126ae8895571

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69452-351-136945203511330 TABLET in 1 BOTTLE, PLASTIC (69452-351-13) 30 tablet2022-01-280000-00-00NoNoCurrent
69452-351-2069452035120100 TABLET in 1 BOTTLE, PLASTIC (69452-351-20) 100 tablet2022-01-280000-00-00NoNoCurrent