Tioconazole 1

Product NDC
0363-0426
11-digit product format
003630426
Labeler code
0363
Product ID
0363-0426_b3a3bba8-ee12-4e9d-a39a-7e88e3e96e35
Type
HUMAN OTC DRUG
Nonproprietary name
Tioconazole
Dosage form
OINTMENT
Route
VAGINAL
Labeler
Walgreen Company
Application
ANDA075915
Marketing category
ANDA
Marketing start
2007-12-19
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
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
0363-0426-54Tioconazole 11 in 1 POUCHOINTMENT17
0363-0426-54Tioconazole 11 in 1 CARTONOINTMENT17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0426-54GM - Gram0363-0426fce0933f-ed7f-4edc-84e3-aa4669d89dd112013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TIOCONAZOLEACTIVE INGREDIENTS57Y5X1117TIOCONAZOLE 1 (TIOCONAZOLE) OINTMENT [WALGREEN COMPANY]2
TIOCONAZOLEACTIVE MOIETYS57Y5X1117TIOCONAZOLE 1 (TIOCONAZOLE) OINTMENT [WALGREEN COMPANY]2
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UTIOCONAZOLE 1 (TIOCONAZOLE) OINTMENT [WALGREEN COMPANY]2
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NCTIOCONAZOLE 1 (TIOCONAZOLE) OINTMENT [WALGREEN COMPANY]2
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UTIOCONAZOLE 1 (TIOCONAZOLE) OINTMENT [WALGREEN COMPANY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0426TIOCONAZOLE 1 (TIOCONAZOLE) OINTMENT [WALGREEN COMPANY]7Current NDC, Legacy NDC, 2 package rows20241220_c05a4413-8a5f-4b91-9c22-b1db785e8e9e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198380tioconazole 6.5 % Vaginal OintmentPSNc05a4413-8a5f-4b91-9c22-b1db785e8e9e7
198380tioconazole 0.065 MG/MG Vaginal OintmentSCDc05a4413-8a5f-4b91-9c22-b1db785e8e9e7
198380tioconazole 6.5 % Vaginal OintmentSYc05a4413-8a5f-4b91-9c22-b1db785e8e9e7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0426-54003630426541 POUCH in 1 CARTON (0363-0426-54) / 1 APPLICATOR in 1 POUCH / 4.6 g in 1 APPLICATOR1 pouch2007-12-190000-00-00NoNoCurrent