FDA.reportPublic FDA data

Terbinafine Hydrochloride

Product NDC
71205-127
11-digit product format
712050127
Labeler code
71205
Product ID
71205-127_ebcef20e-0991-4cd7-b79c-0d1a29b90fed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Terbinafine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA077714
Marketing category
ANDA
Marketing start
2010-12-27
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
71205-127-14Terbinafine Hydrochloride14 in 1 BOTTLETABLET146
71205-127-15Terbinafine Hydrochloride15 in 1 BOTTLETABLET156
71205-127-30Terbinafine Hydrochloride30 in 1 BOTTLETABLET306
71205-127-35Terbinafine Hydrochloride35 in 1 BOTTLETABLET356
71205-127-42Terbinafine Hydrochloride42 in 1 BOTTLETABLET426
71205-127-45Terbinafine Hydrochloride45 in 1 BOTTLETABLET456
71205-127-60Terbinafine Hydrochloride60 in 1 BOTTLETABLET606
71205-127-90Terbinafine Hydrochloride90 in 1 BOTTLETABLET906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-127-14EA - Each71205-12716b05d42-a474-495c-9fcb-ba75ccaf5bad12022-08-04
71205-127-30EA - Each71205-127c6ed72b9-76b3-4bf9-b697-6ffbbb41732512018-12-13
71205-127-35EA - Each71205-12762e946ee-ac2b-42f9-9ecd-c46444ea716312018-11-06
71205-127-45EA - Each71205-127546fa776-2784-4a59-a35b-5caf5521290f12019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-127TERBINAFINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]6Current NDC, Legacy NDC, 8 package rows20220820_4e515f99-7fc7-4692-9105-8e87c27d4e79.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313222terbinafine HCl 250 MG Oral TabletPSN4e515f99-7fc7-4692-9105-8e87c27d4e796
313222terbinafine 250 MG Oral TabletSCD4e515f99-7fc7-4692-9105-8e87c27d4e796
313222terbinafine (as terbinafine HCl) 250 MG Oral TabletSY4e515f99-7fc7-4692-9105-8e87c27d4e796

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-127-147120501271414 TABLET in 1 BOTTLE (71205-127-14) 14 tablet2022-05-170000-00-00NoNoCurrent
71205-127-157120501271515 TABLET in 1 BOTTLE (71205-127-15) 15 tablet2018-10-010000-00-00NoNoCurrent
71205-127-307120501273030 TABLET in 1 BOTTLE (71205-127-30) 30 tablet2018-10-010000-00-00NoNoCurrent
71205-127-357120501273535 TABLET in 1 BOTTLE (71205-127-35) 35 tablet2018-10-010000-00-00NoNoCurrent
71205-127-427120501274242 TABLET in 1 BOTTLE (71205-127-42) 42 tablet2022-08-150000-00-00NoNoCurrent
71205-127-457120501274545 TABLET in 1 BOTTLE (71205-127-45) 45 tablet2018-10-010000-00-00NoNoCurrent
71205-127-607120501276060 TABLET in 1 BOTTLE (71205-127-60) 60 tablet2022-05-170000-00-00NoNoCurrent
71205-127-907120501279090 TABLET in 1 BOTTLE (71205-127-90) 90 tablet2022-05-170000-00-00NoNoCurrent