Tioconazole 1

Product NDC
37808-426
11-digit product format
378080426
Labeler code
37808
Product ID
37808-426_1a9e72ed-ef88-4ddb-b23b-007507cc3b15
Type
HUMAN OTC DRUG
Nonproprietary name
Tioconazole
Dosage form
OINTMENT
Route
VAGINAL
Labeler
H E B
Application
ANDA075915
Marketing category
ANDA
Marketing start
2016-05-09
Substance
TIOCONAZOLE
Active strength
6.5 g/100g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tioconazole 1
Listing expiration
2027-12-31

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
37808-426-54Tioconazole 11 in 1 POUCHOINTMENT13
37808-426-54Tioconazole 11 in 1 CARTONOINTMENT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-426TIOCONAZOLE 1 (TIOCONAZOLE) OINTMENT [H E B]2Current NDC, Legacy NDC, 2 package rows20180619_8bd3f5e8-5a8f-4d6a-b257-c315eec66318.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198380tioconazole 6.5 % Vaginal OintmentPSN8bd3f5e8-5a8f-4d6a-b257-c315eec663183
198380tioconazole 0.065 MG/MG Vaginal OintmentSCD8bd3f5e8-5a8f-4d6a-b257-c315eec663183
198380tioconazole 6.5 % Vaginal OintmentSY8bd3f5e8-5a8f-4d6a-b257-c315eec663183

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-426-54378080426541 POUCH in 1 CARTON (37808-426-54) / 1 APPLICATOR in 1 POUCH / 4.6 g in 1 APPLICATOR1 pouch2016-05-090000-00-00NoNoCurrent