FDA.reportPublic FDA data

Terbinafine

Product NDC
70518-4421
11-digit product format
705184421
Labeler code
70518
Product ID
70518-4421_46904a73-bc1d-58d2-e063-6294a90afd89
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Terbinafine
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA077533
Marketing category
ANDA
Marketing start
2025-08-04
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
70518-4421-0Terbinafine90 in 1 BOTTLE, PLASTICTABLET904
70518-4421-1Terbinafine45 in 1 BOTTLE, PLASTICTABLET454
70518-4421-2Terbinafine30 in 1 BLISTER PACKTABLET304
70518-4421-3Terbinafine30 in 1 BOTTLE, PLASTICTABLET304

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313222terbinafine HCl 250 MG Oral TabletPSNcacf5fe4-8c24-47ed-9a2b-b70aa5d45ef24
313222terbinafine 250 MG Oral TabletSCDcacf5fe4-8c24-47ed-9a2b-b70aa5d45ef24
313222terbinafine (as terbinafine HCl) 250 MG Oral TabletSYcacf5fe4-8c24-47ed-9a2b-b70aa5d45ef24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4421-07051844210090 TABLET in 1 BOTTLE, PLASTIC (70518-4421-0) 90 tablet2025-08-04NoNoCurrent
70518-4421-17051844210145 TABLET in 1 BOTTLE, PLASTIC (70518-4421-1) 45 tablet2025-08-22NoNoCurrent
70518-4421-27051844210230 TABLET in 1 BLISTER PACK (70518-4421-2) 30 tablet2025-09-02NoNoCurrent
70518-4421-37051844210330 TABLET in 1 BOTTLE, PLASTIC (70518-4421-3) 30 tablet2025-09-10NoNoCurrent