NDC 70518-1191

Terbinafine

Terbinafine

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

Product ID70518-1191_6c476643-e7c6-5e44-e053-2991aa0afeef
NDC70518-1191
Product TypeHuman Prescription Drug
Proprietary NameTerbinafine
Generic NameTerbinafine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-05-14
Marketing CategoryANDA / ANDA
Application NumberANDA077533
Labeler NameREMEDYREPACK INC.
Substance NameTERBINAFINE HYDROCHLORIDE
Active Ingredient Strength250 1/1
Pharm ClassesAllylamine [CS],Allylamine Antifungal [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 70518-1191-1

30 TABLET in 1 BLISTER PACK (70518-1191-1)
Marketing Start Date2019-02-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-1191-1 [70518119101]

Terbinafine TABLET
Marketing CategoryANDA
Application NumberANDA077533
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-02-08

NDC 70518-1191-0 [70518119100]

Terbinafine TABLET
Marketing CategoryANDA
Application NumberANDA077533
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-05-14

Drug Details

Active Ingredients

IngredientStrength
TERBINAFINE HYDROCHLORIDE250 1/1

OpenFDA Data

SPL SET ID:80aab848-8739-4259-a092-ed99d0f6a56d
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
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.