FDA.reportPublic FDA data

Terbinafine

Product NDC
16714-795
11-digit product format
167140795
Labeler code
16714
Product ID
16714-795_959f3136-b10d-4a73-a11a-1fae5bd72fb6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Terbinafine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
NorthStar Rx LLC
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
16714-795-01Terbinafine30 in 1 BOTTLETABLET306
16714-795-02Terbinafine100 in 1 BOTTLETABLET1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-795-01EA - Each16714-795ea3acd27-9b53-4e0b-99c9-1589309279ca12018-09-05
16714-795-02EA - Each16714-795e241ba6a-378b-47a6-b4ec-1f441df0e8c812018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-795TERBINAFINE (TERBINAFINE HYDROCHLORIDE) TABLET [NORTHSTAR RX LLC]6Current NDC, Legacy NDC, 2 package rows20240421_8f87e3e1-4c9c-497a-af20-8ab52cfeef60.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313222terbinafine HCl 250 MG Oral TabletPSN79a39fb1-12b7-4b1e-9f28-102af34d04597
313222terbinafine 250 MG Oral TabletSCD79a39fb1-12b7-4b1e-9f28-102af34d04597
313222terbinafine (as terbinafine HCl) 250 MG Oral TabletSY79a39fb1-12b7-4b1e-9f28-102af34d04597
313222terbinafine HCl 250 MG Oral TabletPSN8f87e3e1-4c9c-497a-af20-8ab52cfeef606
313222terbinafine 250 MG Oral TabletSCD8f87e3e1-4c9c-497a-af20-8ab52cfeef606
313222terbinafine (as terbinafine HCl) 250 MG Oral TabletSY8f87e3e1-4c9c-497a-af20-8ab52cfeef606
313222terbinafine HCl 250 MG Oral TabletPSN50657431-1cd9-42dd-9cfc-57db8713d2675
313222terbinafine 250 MG Oral TabletSCD50657431-1cd9-42dd-9cfc-57db8713d2675
313222terbinafine (as terbinafine HCl) 250 MG Oral TabletSY50657431-1cd9-42dd-9cfc-57db8713d2675
313222terbinafine HCl 250 MG Oral TabletPSNd12be96b-e2de-b356-e053-2a95a90a1f992
313222terbinafine 250 MG Oral TabletSCDd12be96b-e2de-b356-e053-2a95a90a1f992
313222terbinafine (as terbinafine HCl) 250 MG Oral TabletSYd12be96b-e2de-b356-e053-2a95a90a1f992

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-795-011671407950130 TABLET in 1 BOTTLE (16714-795-01) 30 tablet2007-07-020000-00-00NoNoCurrent
16714-795-0216714079502100 TABLET in 1 BOTTLE (16714-795-02) 100 tablet2007-07-020000-00-00NoNoCurrent