Leader Tioconazole 1

Product NDC
70000-0357
11-digit product format
700000357
Labeler code
70000
Product ID
70000-0357_d5dec365-3936-4367-9df2-57a919a11eb3
Type
HUMAN OTC DRUG
Nonproprietary name
Tioconazole
Dosage form
OINTMENT
Route
VAGINAL
Labeler
Cardinal Health 110, LLC. dba Leader
Application
ANDA075915
Marketing category
ANDA
Marketing start
2018-04-20
Substance
TIOCONAZOLE
Active strength
6.5 g/100g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Leader Tioconazole 1
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TIOCONAZOLE6.5 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiS57Y5X1117
Rxcui198380

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0357-1Leader Tioconazole 11 in 1 CARTONOINTMENT13
70000-0357-1Leader Tioconazole 14.6 g in 1 APPLICATOROINTMENT4.63

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0357-1GM - Gram70000-03576b043d47-1caa-4787-9db2-bdd503b5267312019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0357LEADER TIOCONAZOLE 1 (TIOCONAZOLE) OINTMENT [CARDINAL HEALTH 110, LLC. DBA LEADER]3Current NDC, Legacy NDC, 2 package rows20250302_6db31d83-acd7-4e4e-8f98-fe46102a6832.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198380tioconazole 6.5 % Vaginal OintmentPSN6db31d83-acd7-4e4e-8f98-fe46102a68323
198380tioconazole 0.065 MG/MG Vaginal OintmentSCD6db31d83-acd7-4e4e-8f98-fe46102a68323
198380tioconazole 6.5 % Vaginal OintmentSY6db31d83-acd7-4e4e-8f98-fe46102a68323

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0357-1700000357011 APPLICATOR in 1 CARTON (70000-0357-1) / 4.6 g in 1 APPLICATOR1 applicator2018-04-200000-00-00NoNoCurrent