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NDC 63629-8623-01 Ciclopirox 80 mg/mL Details

Ciclopirox 80 mg/mL

Ciclopirox is a TOPICAL SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is CICLOPIROX.

MedlinePlus Drug Summary

Ciclopirox topical solution is used along with regular nail trimming to treat fungal infections of the fingernails and toenails (an infection that may cause nail discoloration, splitting and pain). Ciclopirox is in a class of medications called antifungals. It works by stopping the growth of nail fungus.

Related Packages: 63629-8623-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Ciclopirox Topical

Product Information

NDC	63629-8623
Product ID	63629-8623_00b59586-8858-c5ba-e063-6294a90af650
Associated GPIs
GCN Sequence Number	037020
GCN Sequence Number Description	ciclopirox SOLUTION 8 % TOPICAL
HIC3	Q5F
HIC3 Description	TOPICAL ANTIFUNGALS
GCN	08040
HICL Sequence Number	016915
HICL Sequence Number Description	CICLOPIROX
Brand/Generic	Generic
Proprietary Name	Ciclopirox
Proprietary Name Suffix	n/a
Non-Proprietary Name	Ciclopirox
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	SOLUTION
Route	TOPICAL
Active Ingredient Strength	80
Active Ingredient Units	mg/mL
Substance Name	CICLOPIROX
Labeler Name	Bryant Ranch Prepack
Pharmaceutical Class	Decreased DNA Replication [PE], Decreased Protein Synthesis [PE], Decreased RNA Replication [PE], Protein Synthesis Inhibitors [MoA]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA077623
Listing Certified Through	2024-12-31

Package

NDC 63629-8623-01 (63629862301)

Pricing Information	N/A
NDC Package Code	63629-8623-1
Billing NDC	63629862301
Package	1 BOTTLE, WITH APPLICATOR in 1 CARTON (63629-8623-1) / 6.6 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Start Date	2021-07-09
NDC Exclude Flag	N