TERBINAFINE HYDROCHLORIDE

Product NDC
51407-995
11-digit product format
514070995
Labeler code
51407
Product ID
51407-995_507501c8-581c-ba3b-e063-6394a90aa989
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Terbinafine Tablets 250 mg
Dosage form
TABLET
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA076390
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
TERBINAFINE HYDROCHLORIDE
Listing expiration
2027-12-31

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
51407-995-01TERBINAFINE HYDROCHLORIDE100 in 1 BOTTLETABLET1001
51407-995-30TERBINAFINE HYDROCHLORIDE30 in 1 BOTTLETABLET301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313222terbinafine HCl 250 MG Oral TabletPSN50750500-6cb0-62dc-e063-6294a90a15bc1
313222terbinafine 250 MG Oral TabletSCD50750500-6cb0-62dc-e063-6294a90a15bc1
313222terbinafine (as terbinafine HCl) 250 MG Oral TabletSY50750500-6cb0-62dc-e063-6294a90a15bc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51407-995-0151407099501100 TABLET in 1 BOTTLE (51407-995-01) 100 tablet2025-12-31NoNoHistorical
51407-995-305140709953030 TABLET in 1 BOTTLE (51407-995-30) 30 tablet2025-12-31NoNoHistorical