Ciclopirox

Product NDC
52565-032
11-digit product format
525650032
Labeler code
52565
Product ID
52565-032_1ea9136f-7e4f-46a0-b740-5a130b190809
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ciclopirox
Dosage form
SHAMPOO
Route
TOPICAL
Labeler
Teligent Pharma, Inc.
Application
ANDA209975
Marketing category
ANDA
Marketing start
2018-04-05
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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d24c6245-86b5-4444-bc75-c1ac73ab3016Product name120180612
c7015f08-288e-4cfa-93b5-f4959a4814aeProduct name120150324
3f974526-143f-9d19-ee0c-98eeee0cdc3fProduct name120140508
5c035cac-559a-7171-c5cb-f0bd0d0fbc86Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52565-032-12Ciclopirox1 in 1 CARTONSHAMPOO12
52565-032-12Ciclopirox120 mL in 1 BOTTLE, PLASTICSHAMPOO1202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52565-032-12ML - Milliliter52565-0323d1399db-7a9a-412e-a196-4e8b47bdc6f212018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52565-032CICLOPIROX SHAMPOO [TELIGENT PHARMA, INC.]2Legacy NDC, 2 package rows20190910_4db19b1a-6c1a-159f-7d88-61429bbbcb56.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
250344ciclopirox 1 % Medicated ShampooPSN4db19b1a-6c1a-159f-7d88-61429bbbcb562
250344ciclopirox 10 MG/ML Medicated ShampooSCD4db19b1a-6c1a-159f-7d88-61429bbbcb562
250344ciclopirox 1 % Medicated ShampooSY4db19b1a-6c1a-159f-7d88-61429bbbcb562

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
52565-032-12525650032121 BOTTLE, PLASTIC in 1 CARTON (52565-032-12) > 120 mL in 1 BOTTLE, PLASTIC2018-04-050000-00-00NoNoCurrent