Loprox

Product NDC
43538-550
11-digit product format
435380550
Labeler code
43538
Product ID
43538-550_0efc4273-be47-4751-98f8-626f3fb85754
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ciclopirox olamine
Dosage form
SUSPENSION
Route
TOPICAL
Labeler
Medimetriks Pharmaceuticals, Inc.
Application
NDA019824
Marketing category
NDA
Marketing start
2016-10-14
Marketing end
0000-00-00
Substance
CICLOPIROX OLAMINE
Active strength
8 mg/mL
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
2020-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43538-550-602023-10-26C16284748780-10191ceaa-6821-198a-e063-dbdaa90aec3ebefa91b7-ea2b-4fbb-9e4c-45993bfd7c18
43538-550-602023-07-28C16284748780-10191ceaa-6821-198a-e063-dbdaa90aec3ebefa91b7-ea2b-4fbb-9e4c-45993bfd7c18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43538-550-60ML - Milliliter43538-5507f68cc38-3537-4f22-b77d-3579c9f1718112017-03-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43538-550-60435380550601 BOTTLE in 1 CARTON (43538-550-60) > 60 mL in 1 BOTTLE1 bottle2016-10-140000-00-00NoNoCurrent