TERBINAFINE

Product NDC
72189-243
11-digit product format
721890243
Labeler code
72189
Product ID
72189-243_2c28596f-8fc8-42e5-e063-6294a90a0ad6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TERBINAFINE
Dosage form
TABLET
Route
ORAL
Labeler
direct rx
Application
ANDA078297
Marketing category
ANDA
Marketing start
2021-07-23
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
72189-243-30TERBINAFINE30 in 1 BOTTLETABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-243-30EA - Each72189-243527cd2ce-29c8-4f66-86b0-d09b7a13170c12021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-243TERBINAFINE TABLET [DIRECT RX]2Current NDC, Legacy NDC, 1 package rows20250121_c7cf55e2-f637-e2d9-e053-2995a90a6270.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313222terbinafine HCl 250 MG Oral TabletPSNc7cf55e2-f637-e2d9-e053-2995a90a62702
313222terbinafine 250 MG Oral TabletSCDc7cf55e2-f637-e2d9-e053-2995a90a62702
313222terbinafine (as terbinafine HCl) 250 MG Oral TabletSYc7cf55e2-f637-e2d9-e053-2995a90a62702

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72189-243-307218902433030 TABLET in 1 BOTTLE (72189-243-30) 30 tablet2021-07-230000-00-00NoNoCurrent