NDC 53002-0550

Terbinafine

Terbinafine Hydrochloride

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

Product ID53002-0550_fcecd3c8-639d-440c-80d1-b5ade10d6c7b
NDC53002-0550
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 NameRPK Pharmaceuticals, Inc.
Substance NameTERBINAFINE HYDROCHLORIDE
Active Ingredient Strength250 mg/1
Pharm ClassesAllylamine [CS],Allylamine Antifungal [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 53002-0550-3

30 TABLET in 1 BOTTLE (53002-0550-3)
Marketing Start Date2019-01-01
NDC Exclude FlagN
Sample Package?N

Drug Details

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.