NDC 63629-2807

Terbinafine Hydrochloride

Terbinafine

Terbinafine Hydrochloride is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is Terbinafine Hydrochloride.

Product ID63629-2807_653ab04e-0a11-415d-bf8b-4c64228066d6
NDC63629-2807
Product TypeHuman Prescription Drug
Proprietary NameTerbinafine Hydrochloride
Generic NameTerbinafine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2011-01-01
Marketing CategoryANDA / ANDA
Application NumberANDA077533
Labeler NameBryant Ranch Prepack
Substance NameTERBINAFINE HYDROCHLORIDE
Active Ingredient Strength250 mg/1
Pharm ClassesAllylamine [CS],Allylamine Antifungal [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 63629-2807-4

100 TABLET in 1 BOTTLE (63629-2807-4)
Marketing Start Date2011-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63629-2807-3 [63629280703]

Terbinafine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA077533
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-01-01
Inactivation Date2020-01-31

NDC 63629-2807-1 [63629280701]

Terbinafine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA077533
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-01-01
Inactivation Date2020-01-31

NDC 63629-2807-4 [63629280704]

Terbinafine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA077533
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-01-01
Inactivation Date2020-01-31

NDC 63629-2807-8 [63629280708]

Terbinafine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA077533
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-01-01
Marketing End Date2015-12-30
Inactivation Date2020-01-31

NDC 63629-2807-6 [63629280706]

Terbinafine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA077533
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-01-01
Inactivation Date2020-01-31

NDC 63629-2807-5 [63629280705]

Terbinafine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA077533
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-01-01
Inactivation Date2020-01-31

NDC 63629-2807-2 [63629280702]

Terbinafine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA077533
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-01-01
Inactivation Date2020-01-31

NDC 63629-2807-7 [63629280707]

Terbinafine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA077533
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-01-01
Marketing End Date2015-12-30
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
TERBINAFINE HYDROCHLORIDE250 mg/1

OpenFDA Data

SPL SET ID:d3592751-686b-48bd-a8d4-14c86bbcf510
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"

    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
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