NDC 68071-4712

Terbinafine

Terbinafine Hydrochloride

Terbinafine is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Nucare Pharmaceuticals,inc.. The primary component is Terbinafine Hydrochloride.

Product ID68071-4712_7f87094a-25b3-06cc-e053-2991aa0a0ba5
NDC68071-4712
Product TypeHuman Prescription Drug
Proprietary NameTerbinafine
Generic NameTerbinafine Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2007-07-02
Marketing CategoryANDA / ANDA
Application NumberANDA078297
Labeler NameNuCare Pharmaceuticals,Inc.
Substance NameTERBINAFINE HYDROCHLORIDE
Active Ingredient Strength250 mg/1
Pharm ClassesAllylamine [CS],Allylamine Antifungal [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68071-4712-3

30 TABLET in 1 BOTTLE (68071-4712-3)
Marketing Start Date2019-01-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68071-4712-3 [68071471203]

Terbinafine TABLET
Marketing CategoryANDA
Application NumberANDA078297
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-01-15

Drug Details

Active Ingredients

IngredientStrength
TERBINAFINE HYDROCHLORIDE250 mg/1

OpenFDA Data

SPL SET ID:7f87094a-25b2-06cc-e053-2991aa0a0ba5
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 313222
  • UPC Code
  • 0368071471236
  • Pharmacological Class

    • Allylamine [CS]
    • Allylamine Antifungal [EPC]
    • Allylamine [CS]
    • Allylamine Antifungal [EPC]

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

    NDCBrand NameGeneric Name
    16714-795TerbinafineTerbinafine Hydrochloride
    68071-4712TerbinafineTerbinafine
    69097-859TerbinafineTerbinafine
    70518-1191TerbinafineTerbinafine
    71205-152TerbinafineTerbinafine
    71205-061TerbinafineTerbinafine
    76282-209TerbinafineTerbinafine
    50090-3575TerbinafineTerbinafine
    50090-3654TerbinafineTerbinafine
    55700-344TerbinafineTerbinafine
    65862-079TerbinafineTerbinafine
    67405-543TerbinafineTerbinafine
    68071-4873TerbinafineTerbinafine
    71335-1124TerbinafineTerbinafine
    68788-7450TerbinafineTerbinafine
    53002-0550TerbinafineTerbinafine
    70518-2941TerbinafineTerbinafine
    68788-7722TerbinafineTerbinafine
    71205-492TerbinafineTerbinafine
    71335-1668TerbinafineTerbinafine
    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
    0067-3998LamisilTERBINAFINE HYDROCHLORIDE
    0067-3999LamisilTERBINAFINE HYDROCHLORIDE
    0067-6292LAMISILTERBINAFINE HYDROCHLORIDE
    0067-6293LAMISILTERBINAFINE HYDROCHLORIDE
    0067-6296LAMISILTERBINAFINE HYDROCHLORIDE
    0067-6297LAMISILTERBINAFINE HYDROCHLORIDE
    0078-0179Lamisilterbinafine hydrochloride
    0067-8100Lamisil ATTerbinafine Hydrochloride
    0067-8114Lamisil ATTerbinafine Hydrochloride
    37012-080ShopkoTerbinafine Hydrochloride
    41190-083ShopRiteTerbinafine Hydrochloride
    0363-2083Terbinafine HydrochlorideTerbinafine Hydrochloride
    0536-1117Terbinafine HydrochlorideTerbinafine Hydrochloride
    16714-501terbinafine hydrochlorideterbinafine hydrochloride
    21695-630Terbinafine HydrochlorideTerbinafine Hydrochloride
    31722-209Terbinafine HydrochlorideTerbinafine
    37205-941Terbinafine HydrochlorideTerbinafine Hydrochloride
    0363-2080WalgreensTerbinafine Hydrochloride

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.