CICLOPIROX

Product NDC
63629-8621
11-digit product format
636298621
Labeler code
63629
Product ID
63629-8621_1b3a1cf8-6673-4fe7-92cb-eb2bb3a36537
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CICLOPIROX
Dosage form
GEL
Route
TOPICAL
Labeler
Bryant Ranch Prepack
Application
ANDA078266
Marketing category
ANDA
Marketing start
2009-01-07
Substance
CICLOPIROX
Active strength
7.7 mg/g
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CICLOPIROX
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CICLOPIROX7.7 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii19W019ZDRJ
Rxcui313941

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-8621-1CICLOPIROX45 g in 1 TUBEGEL45103
63629-8621-1CICLOPIROX1 in 1 CARTONGEL1103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8621-1GM - Gram63629-8621a473b461-41a1-4a6d-96b6-bbc71d380ed212023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8621CICLOPIROX GEL [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 2 package rows20230616_933785c2-22ee-4e3a-a46a-e7cd545b08ac.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313941ciclopirox 0.77 % Topical GelPSN933785c2-22ee-4e3a-a46a-e7cd545b08ac103
313941ciclopirox 0.0077 MG/MG Topical GelSCD933785c2-22ee-4e3a-a46a-e7cd545b08ac103
313941ciclopirox 0.77 % (ciclopirox olamine 1 % ) Topical GelSY933785c2-22ee-4e3a-a46a-e7cd545b08ac103
313941ciclopirox 0.77 % Topical GelSY933785c2-22ee-4e3a-a46a-e7cd545b08ac103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8621-1636298621011 TUBE in 1 CARTON (63629-8621-1) / 45 g in 1 TUBE1 tube2009-01-070000-00-00NoNoCurrent