FDA.reportPublic FDA data

terbinafine hydrochloride

Product NDC
82804-220
11-digit product format
828040220
Labeler code
82804
Product ID
82804-220_839cfff6-fb7f-489f-8cdb-5abda9bffd31
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
terbinafine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
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
82804-220-30terbinafine hydrochloride30 in 1 BOTTLE, PLASTICTABLET302
82804-220-42terbinafine hydrochloride42 in 1 BOTTLE, PLASTICTABLET422

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82804-220-30EA - Each82804-220ff357eed-7a0f-4642-902d-5b44b16c73e412025-06-13
82804-220-42EA - Each82804-22093f0067b-4ba8-4786-8776-eacfdef4692e12026-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-220TERBINAFINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]1Current NDC, 2 package rows20250501_53235270-6ffb-44c8-aa55-debf59e1d964.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313222terbinafine HCl 250 MG Oral TabletPSN53235270-6ffb-44c8-aa55-debf59e1d9642
313222terbinafine 250 MG Oral TabletSCD53235270-6ffb-44c8-aa55-debf59e1d9642
313222terbinafine (as terbinafine HCl) 250 MG Oral TabletSY53235270-6ffb-44c8-aa55-debf59e1d9642

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82804-220-308280402203030 TABLET in 1 BOTTLE, PLASTIC (82804-220-30) 30 tablet2025-04-24NoNoCurrent
82804-220-428280402204242 TABLET in 1 BOTTLE, PLASTIC (82804-220-42) 42 tablet2025-09-04NoNoCurrent