FDA.reportPublic FDA data

Terbinafine

Product NDC
71205-061
11-digit product format
712050061
Labeler code
71205
Product ID
71205-061_f2548203-c59d-46a1-bf6f-098e91344380
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
71205-061-30Terbinafine30 in 1 BOTTLETABLET305
71205-061-35Terbinafine35 in 1 BOTTLETABLET355

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-061-30EA - Each71205-0612305aec7-6798-4cab-abb8-03a84057336812018-08-13
71205-061-35EA - Each71205-06161b70a9e-677a-42fd-bfc8-155cf89eacd312018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-061TERBINAFINE (TERBINAFINE HYDROCHLORIDE) TABLET [PROFICIENT RX LP]5Current NDC, Legacy NDC, 2 package rows20240927_0a54cc4f-0789-46ce-875f-df759aa95d9c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313222terbinafine HCl 250 MG Oral TabletPSN0a54cc4f-0789-46ce-875f-df759aa95d9c5
313222terbinafine 250 MG Oral TabletSCD0a54cc4f-0789-46ce-875f-df759aa95d9c5
313222terbinafine (as terbinafine HCl) 250 MG Oral TabletSY0a54cc4f-0789-46ce-875f-df759aa95d9c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-061-307120500613030 TABLET in 1 BOTTLE (71205-061-30) 30 tablet2018-07-020000-00-00NoNoCurrent
71205-061-357120500613535 TABLET in 1 BOTTLE (71205-061-35) 35 tablet2018-07-020000-00-00NoNoCurrent
71205-061-607120500616060 TABLET in 1 BOTTLE (71205-061-60) 60 tablet2018-07-020000-00-00NoNoCurrent
71205-061-907120500619090 TABLET in 1 BOTTLE (71205-061-90) 90 tablet2018-07-020000-00-00NoNoCurrent