NDC 71205-127

Terbinafine Hydrochloride

Terbinafine Hydrochloride

Terbinafine Hydrochloride 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 ID71205-127_3f84f21e-5974-491a-9781-59b1ed544902
NDC71205-127
Product TypeHuman Prescription Drug
Proprietary NameTerbinafine Hydrochloride
Generic NameTerbinafine Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2010-12-27
Marketing CategoryANDA / ANDA
Application NumberANDA077714
Labeler NameProficient Rx LP
Substance NameTERBINAFINE HYDROCHLORIDE
Active Ingredient Strength250 mg/1
Pharm ClassesAllylamine [CS],Allylamine Antifungal [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 71205-127-14

14 TABLET in 1 BOTTLE (71205-127-14)
Marketing Start Date2022-05-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71205-127-30 [71205012730]

Terbinafine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA077714
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-10-01

NDC 71205-127-35 [71205012735]

Terbinafine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA077714
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-10-01

NDC 71205-127-45 [71205012745]

Terbinafine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA077714
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-10-01

NDC 71205-127-15 [71205012715]

Terbinafine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA077714
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-10-01

Drug Details

Active Ingredients

IngredientStrength
TERBINAFINE HYDROCHLORIDE250 mg/1

OpenFDA Data

SPL SET ID:4e515f99-7fc7-4692-9105-8e87c27d4e79
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 313222

    • Pharmacological Class

    • Allylamine [CS]
    • Allylamine Antifungal [EPC]

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

    NDCBrand NameGeneric Name
    0363-2083Terbinafine HydrochlorideTerbinafine Hydrochloride
    0536-1117Terbinafine HydrochlorideTerbinafine Hydrochloride
    16714-501terbinafine hydrochlorideterbinafine hydrochloride
    21695-630Terbinafine HydrochlorideTerbinafine Hydrochloride
    31722-209Terbinafine HydrochlorideTerbinafine
    37205-941Terbinafine HydrochlorideTerbinafine Hydrochloride
    68016-080Terbinafine HydrochlorideTerbinafine Hydrochloride
    68071-1640Terbinafine HydrochlorideTerbinafine Hydrochloride
    68071-4500Terbinafine HydrochlorideTerbinafine Hydrochloride
    68071-4578Terbinafine HydrochlorideTerbinafine Hydrochloride
    68151-1327Terbinafine HydrochlorideTerbinafine Hydrochloride
    68788-7187Terbinafine HydrochlorideTerbinafine Hydrochloride
    68788-9094Terbinafine HydrochlorideTerbinafine Hydrochloride
    68788-9814Terbinafine HydrochlorideTerbinafine Hydrochloride
    70000-0338Terbinafine HydrochlorideTerbinafine Hydrochloride
    70518-0670Terbinafine HydrochlorideTerbinafine Hydrochloride
    70518-0553Terbinafine HydrochlorideTerbinafine Hydrochloride
    70518-1743Terbinafine HydrochlorideTerbinafine Hydrochloride
    71205-127Terbinafine HydrochlorideTerbinafine Hydrochloride
    71335-0257Terbinafine HydrochlorideTerbinafine Hydrochloride
    71335-0918Terbinafine HydrochlorideTerbinafine Hydrochloride
    43063-906Terbinafine HydrochlorideTerbinafine Hydrochloride
    43063-598Terbinafine HydrochlorideTerbinafine Hydrochloride
    43353-893Terbinafine HydrochlorideTerbinafine Hydrochloride
    50090-1278Terbinafine HydrochlorideTerbinafine Hydrochloride
    51672-2080Terbinafine HydrochlorideTerbinafine Hydrochloride
    51991-526Terbinafine HydrochlorideTerbinafine Hydrochloride
    55111-250Terbinafine HydrochlorideTerbinafine Hydrochloride
    55648-743TERBINAFINE HYDROCHLORIDETERBINAFINE HYDROCHLORIDE
    60429-222Terbinafine HydrochlorideTerbinafine Hydrochloride
    61919-451TERBINAFINE HYDROCHLORIDETERBINAFINE HYDROCHLORIDE
    63187-213Terbinafine HydrochlorideTerbinafine Hydrochloride
    63187-792Terbinafine HydrochlorideTerbinafine Hydrochloride
    63187-111Terbinafine HydrochlorideTerbinafine Hydrochloride
    63629-2807Terbinafine HydrochlorideTerbinafine Hydrochloride
    64679-209Terbinafine HydrochlorideTerbinafine Hydrochloride
    64679-743TERBINAFINE HYDROCHLORIDETERBINAFINE HYDROCHLORIDE
    67405-500Terbinafine HydrochlorideTerbinafine Hydrochloride
    63629-8137Terbinafine HydrochlorideTerbinafine Hydrochloride
    41250-080AntifungalTerbinafine Hydrochloride
    41520-080Antifungal FootTerbinafine Hydrochloride
    11673-080Athletes FootTerbinafine Hydrochloride
    11822-0080Athletes FootTerbinafine Hydrochloride
    21130-080Athletes FootTerbinafine Hydrochloride
    36800-080Athletes FootTerbinafine Hydrochloride
    37808-080Athletes FootTerbinafine Hydrochloride
    41163-080athletes footTerbinafine Hydrochloride
    24385-524Good Neighbor PharmacyTerbinafine Hydrochloride
    0179-8715KAISER PERMANENTETerbinafine Hydrochloride
    30142-080KrogerTerbinafine Hydrochloride
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.