FDA.reportPublic FDA data

Terbinafine

Product NDC
72789-394
11-digit product format
727890394
Labeler code
72789
Product ID
72789-394_41231fb9-9811-dfe0-e063-6294a90ab664
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Terbinafine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA078297
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
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
72789-394-42Terbinafine42 in 1 BOTTLE, PLASTICTABLET4224
72789-394-90Terbinafine90 in 1 BOTTLE, PLASTICTABLET9024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-394-42EA - Each72789-394aab65199-d668-4848-8187-878c5c59111b12024-08-12
72789-394-90EA - Each72789-394a5d895eb-6086-4d67-8e7b-135047b29b9512024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-394TERBINAFINE (TERBINAFINE HYDROCHLORIDE) TABLET [PD-RX PHARMACEUTICALS, INC.]23Current NDC, 2 package rows20240806_747fdc13-7c3a-4672-b50c-31c51037bda2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313222terbinafine HCl 250 MG Oral TabletPSN747fdc13-7c3a-4672-b50c-31c51037bda224
313222terbinafine 250 MG Oral TabletSCD747fdc13-7c3a-4672-b50c-31c51037bda224
313222terbinafine (as terbinafine HCl) 250 MG Oral TabletSY747fdc13-7c3a-4672-b50c-31c51037bda224

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72789-394-427278903944242 TABLET in 1 BOTTLE, PLASTIC (72789-394-42) 42 tablet2024-08-05NoNoHistorical
72789-394-907278903949090 TABLET in 1 BOTTLE, PLASTIC (72789-394-90) 90 tablet2024-04-16NoNoHistorical