NDC 21695-630

Terbinafine Hydrochloride

Terbinafine Hydrochloride

Terbinafine Hydrochloride is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Rebel Distributors Corp. The primary component is Terbinafine Hydrochloride.

Product ID21695-630_dfb8fc2d-4899-4891-a985-755fbdf1d525
NDC21695-630
Product TypeHuman Prescription Drug
Proprietary NameTerbinafine Hydrochloride
Generic NameTerbinafine Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2007-07-02
Marketing CategoryANDA / ANDA
Application NumberANDA077533
Labeler NameRebel Distributors Corp
Substance NameTERBINAFINE HYDROCHLORIDE
Active Ingredient Strength250 mg/1
Pharm ClassesAllylamine [CS],Allylamine Antifungal [EPC]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 21695-630-42

42 TABLET in 1 BOTTLE (21695-630-42)
Marketing Start Date2007-07-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 21695-630-30 [21695063030]

Terbinafine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA077533
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-07-02
Inactivation Date2019-09-24

NDC 21695-630-45 [21695063045]

Terbinafine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA077533
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-07-02
Inactivation Date2019-09-24

NDC 21695-630-60 [21695063060]

Terbinafine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA077533
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-07-02
Inactivation Date2019-09-24

NDC 21695-630-90 [21695063090]

Terbinafine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA077533
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-07-02
Inactivation Date2019-09-24

NDC 21695-630-42 [21695063042]

Terbinafine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA077533
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-07-02
Inactivation Date2019-09-24

Drug Details

Active Ingredients

IngredientStrength
TERBINAFINE HYDROCHLORIDE250 mg/1

OpenFDA Data

SPL SET ID:dfb8fc2d-4899-4891-a985-755fbdf1d525
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
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.