Ciclopirox

Product NDC
0168-0449
11-digit product format
001680449
Labeler code
0168
Product ID
0168-0449_710704bb-c966-436e-962e-1c317c27269f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciclopirox
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
Fougera Pharmaceuticals Inc.
Application
ANDA090146
Marketing category
ANDA
Marketing start
2010-05-25
Marketing end
0000-00-00
Substance
CICLOPIROX
Active strength
10 mg/.96mL
Pharmacologic classes
Decreased DNA Replication [PE],Decreased Protein Synthesis [PE],Decreased RNA Replication [PE],Protein Synthesis Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0168-0449-042020-09-18C16284748780-19d75b9d0-e659-f424-e053-dadaa90a57ce288a1cb0-ff4c-482c-9f1a-45ea3dbb3b52
0168-0449-042020-01-31C16284748780-19d75b9d0-e659-f424-e053-dadaa90a57ce288a1cb0-ff4c-482c-9f1a-45ea3dbb3b52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0168-0449-04001680449041 BOTTLE in 1 CARTON (0168-0449-04) > 120 mL in 1 BOTTLE1 bottle2010-05-250000-00-00NoNoCurrent