NDC 71205-152

Terbinafine

Terbinafine

Terbinafine is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Proficient Rx Lp. The primary component is Terbinafine Hydrochloride.

Product ID71205-152_04d8a1a7-d249-4abc-8853-bb68e0db0ad7
NDC71205-152
Product TypeHuman Prescription Drug
Proprietary NameTerbinafine
Generic NameTerbinafine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2016-06-27
Marketing CategoryANDA / ANDA
Application NumberANDA077533
Labeler NameProficient Rx LP
Substance NameTERBINAFINE HYDROCHLORIDE
Active Ingredient Strength250 1/1
Pharm ClassesAllylamine [CS],Allylamine Antifungal [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 71205-152-15

15 TABLET in 1 BOTTLE (71205-152-15)
Marketing Start Date2018-11-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71205-152-15 [71205015215]

Terbinafine TABLET
Marketing CategoryANDA
Application NumberANDA077533
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-11-01

NDC 71205-152-60 [71205015260]

Terbinafine TABLET
Marketing CategoryANDA
Application NumberANDA077533
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-11-01

NDC 71205-152-90 [71205015290]

Terbinafine TABLET
Marketing CategoryANDA
Application NumberANDA077533
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-11-01

NDC 71205-152-35 [71205015235]

Terbinafine TABLET
Marketing CategoryANDA
Application NumberANDA077533
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-11-01

NDC 71205-152-45 [71205015245]

Terbinafine TABLET
Marketing CategoryANDA
Application NumberANDA077533
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-11-01

NDC 71205-152-30 [71205015230]

Terbinafine TABLET
Marketing CategoryANDA
Application NumberANDA077533
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-11-01

Drug Details

Active Ingredients

IngredientStrength
TERBINAFINE HYDROCHLORIDE250 1/1

OpenFDA Data

SPL SET ID:3925dc10-ad66-46a8-bfa5-1a4314be3521
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 313222

    • Pharmacological Class

    • Allylamine [CS]
    • Allylamine Antifungal [EPC]

    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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