NDC 67405-543

Terbinafine

Terbinafine

Terbinafine is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Harris Pharmaceutical, Inc.. The primary component is Terbinafine Hydrochloride.

Product ID67405-543_6154aa0a-55b4-478b-9edd-503a96ec0dac
NDC67405-543
Product TypeHuman Prescription Drug
Proprietary NameTerbinafine
Generic NameTerbinafine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2007-07-30
Marketing CategoryANDA / ANDA
Application NumberANDA077919
Labeler NameHARRIS Pharmaceutical, Inc.
Substance NameTERBINAFINE HYDROCHLORIDE
Active Ingredient Strength250 mg/1
Pharm ClassesAllylamine [CS],Allylamine Antifungal [EPC]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 67405-543-03

30 TABLET in 1 BOTTLE (67405-543-03)
Marketing Start Date2007-07-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67405-543-03 [67405054303]

Terbinafine TABLET
Marketing CategoryANDA
Application NumberANDA077919
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-07-30
Marketing End Date2018-07-30

NDC 67405-543-10 [67405054310]

Terbinafine TABLET
Marketing CategoryANDA
Application NumberANDA077919
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-07-30
Marketing End Date2018-07-30

Drug Details

Active Ingredients

IngredientStrength
TERBINAFINE HYDROCHLORIDE250 mg/1

OpenFDA Data

SPL SET ID:9912d2e8-e71e-4986-bb7c-3f2387be8e29
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 313222

    • Pharmacological Class

    • Allylamine [CS]
    • Allylamine Antifungal [EPC]

    Medicade Reported Pricing

    67405054310 TERBINAFINE HCL 250 MG TABLET

    Pricing Unit: EA | Drug Type:

    67405054303 TERBINAFINE HCL 250 MG TABLET

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Terbinafine" or generic name "Terbinafine"

    NDCBrand NameGeneric Name
    16714-795TerbinafineTerbinafine Hydrochloride
    50090-3575TerbinafineTerbinafine Hydrochloride
    50090-3654TerbinafineTerbinafine Hydrochloride
    53002-0550TerbinafineTerbinafine Hydrochloride
    55700-344TerbinafineTerbinafine Hydrochloride
    62135-572TERBINAFINETerbinafine
    65862-079TerbinafineTerbinafine Hydrochloride
    67405-543TerbinafineTerbinafine
    68071-2579TerbinafineTerbinafine Hydrochloride
    68071-4712TerbinafineTerbinafine Hydrochloride
    68071-4873TerbinafineTerbinafine Hydrochloride
    68788-7450TerbinafineTerbinafine Hydrochloride
    68788-7722TerbinafineTerbinafine
    69097-859TerbinafineTerbinafine
    70518-1191TerbinafineTerbinafine
    70518-2941TerbinafineTerbinafine Hydrochloride
    71205-061TerbinafineTerbinafine Hydrochloride
    71205-152TerbinafineTerbinafine
    76282-209TerbinafineTerbinafine
    71335-1124TerbinafineTerbinafine
    71205-492TerbinafineTerbinafine
    71335-1668TerbinafineTerbinafine
    31722-209Terbinafine HydrochlorideTerbinafine
    63187-213Terbinafine HydrochlorideTerbinafine
    63629-2807Terbinafine HydrochlorideTerbinafine
    68151-1327Terbinafine HydrochlorideTerbinafine
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