Terbinafine

Product NDC
71205-152
11-digit product format
712050152
Labeler code
71205
Product ID
71205-152_86d7ee5e-ebfd-45ea-a520-b6f65814c3e2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Terbinafine
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA077533
Marketing category
ANDA
Marketing start
2016-06-27
Substance
TERBINAFINE HYDROCHLORIDE
Active strength
250 1/1
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 1/1

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
71205-152-15Terbinafine15 in 1 BOTTLETABLET154
71205-152-30Terbinafine30 in 1 BOTTLETABLET304
71205-152-35Terbinafine35 in 1 BOTTLETABLET354
71205-152-45Terbinafine45 in 1 BOTTLETABLET454
71205-152-60Terbinafine60 in 1 BOTTLETABLET604
71205-152-90Terbinafine90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-152-30EA - Each71205-152e6fedd93-f683-49ba-a8fa-6adecc9c07b012019-02-13
71205-152-35EA - Each71205-152e7ceaf77-749c-4ffe-9c38-55736fb80c0312019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-152TERBINAFINE TABLET [PROFICIENT RX LP]4Current NDC, Legacy NDC, 6 package rows20200121_3925dc10-ad66-46a8-bfa5-1a4314be3521.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313222terbinafine HCl 250 MG Oral TabletPSN3925dc10-ad66-46a8-bfa5-1a4314be35214
313222terbinafine 250 MG Oral TabletSCD3925dc10-ad66-46a8-bfa5-1a4314be35214
313222terbinafine (as terbinafine HCl) 250 MG Oral TabletSY3925dc10-ad66-46a8-bfa5-1a4314be35214

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-152-157120501521515 TABLET in 1 BOTTLE (71205-152-15) 15 tablet2018-11-010000-00-00NoNoCurrent
71205-152-307120501523030 TABLET in 1 BOTTLE (71205-152-30) 30 tablet2018-11-010000-00-00NoNoCurrent
71205-152-357120501523535 TABLET in 1 BOTTLE (71205-152-35) 35 tablet2018-11-010000-00-00NoNoCurrent
71205-152-457120501524545 TABLET in 1 BOTTLE (71205-152-45) 45 tablet2018-11-010000-00-00NoNoCurrent
71205-152-607120501526060 TABLET in 1 BOTTLE (71205-152-60) 60 tablet2018-11-010000-00-00NoNoCurrent
71205-152-907120501529090 TABLET in 1 BOTTLE (71205-152-90) 90 tablet2018-11-010000-00-00NoNoCurrent