NDC 42192-715

Ciclopirox

Ciclopirox

Ciclopirox is a Topical Solution in the Human Prescription Drug category. It is labeled and distributed by Acella Pharmaceuticals, Llc. The primary component is Ciclopirox.

Product ID42192-715_bffcf34b-a7bc-4afd-945e-206b674e16ac
NDC42192-715
Product TypeHuman Prescription Drug
Proprietary NameCiclopirox
Generic NameCiclopirox
Dosage FormSolution
Route of AdministrationTOPICAL
Marketing Start Date2019-11-04
Marketing CategoryANDA / ANDA
Application NumberANDA078172
Labeler NameAcella Pharmaceuticals, LLC
Substance NameCICLOPIROX
Active Ingredient Strength80 mg/mL
Pharm ClassesDecreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 42192-715-06

1 BOTTLE in 1 CARTON (42192-715-06) > 6.6 mL in 1 BOTTLE
Marketing Start Date2019-11-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42192-715-06 [42192071506]

Ciclopirox SOLUTION
Marketing CategoryANDA
Application NumberANDA078172
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-11-04

Drug Details

Active Ingredients

IngredientStrength
CICLOPIROX80 mg/mL

Pharmacological Class

  • Decreased DNA Replication [PE]
  • Decreased Protein Synthesis [PE]
  • Decreased RNA Replication [PE]
  • Protein Synthesis Inhibitors [MoA]
  • Decreased DNA Replication [PE]
  • Decreased Protein Synthesis [PE]
  • Decreased RNA Replication [PE]
  • Protein Synthesis Inhibitors [MoA]

NDC Crossover Matching brand name "Ciclopirox" or generic name "Ciclopirox"

NDCBrand NameGeneric Name
0168-0314Ciclopiroxciclopirox
0168-0407CiclopiroxCiclopirox
0168-0449CiclopiroxCiclopirox
0168-0522Ciclopiroxciclopirox
0574-2061CICLOPIROXCICLOPIROX
0591-2159CiclopiroxCiclopirox
0713-0317CiclopiroxCICLOPIROX
21695-475CiclopiroxCiclopirox
42192-714CiclopiroxCiclopirox
42192-715CiclopiroxCiclopirox
45802-141CiclopiroxCiclopirox
45802-401CiclopiroxCiclopirox
47781-530CiclopiroxCiclopirox
50383-419CiclopiroxCiclopirox
51672-1323CiclopiroxCiclopirox
51672-1351Ciclopiroxciclopirox
51672-5302Ciclopiroxciclopirox
52565-032Ciclopiroxciclopirox
61360-1351Ciclopiroxciclopirox
61748-200CICLOPIROXCICLOPIROX
63629-8620CICLOPIROXCICLOPIROX
68071-1524CiclopiroxCiclopirox
68071-4412CiclopiroxCiclopirox
68462-455ciclopiroxciclopirox
68788-6797CiclopiroxCiclopirox
68788-7138CiclopiroxCiclopirox
68071-4977CiclopiroxCiclopirox
43538-500Ciclodanciclopirox
43538-501Ciclodanciclopirox
0187-5180Penlacciclopirox
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