FDA.reportPublic FDA data

terbinafine hydrochloride

Product NDC
50090-7300
11-digit product format
500907300
Labeler code
50090
Product ID
50090-7300_89a89899-6387-409a-b941-51a374183b43
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
terbinafine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
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
50090-7300-0terbinafine hydrochloride30 in 1 BOTTLETABLET301
50090-7300-1terbinafine hydrochloride90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7300-0EA - Each50090-730061275250-6f24-4eb3-81b0-a7236849338b12024-11-05
50090-7300-1EA - Each50090-7300eafa57f0-100e-438c-a68a-408c6387318312024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7300TERBINAFINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]1Current NDC, 2 package rows20241016_8f6d7b1a-5a01-4cc5-b5b7-c126ae889557.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 startSampleExclude flagStatus
50090-7300-05009073000030 TABLET in 1 BOTTLE (50090-7300-0) 30 tablet2024-10-14NoNoCurrent
50090-7300-15009073000190 TABLET in 1 BOTTLE (50090-7300-1) 90 tablet2024-10-14NoNoCurrent