Equaline Tioconazole 1

Product NDC
41163-032
11-digit product format
411630032
Labeler code
41163
Product ID
41163-032_07a00775-6625-48de-9963-5626755d3a04
Type
HUMAN OTC DRUG
Nonproprietary name
Tioconazole
Dosage form
OINTMENT
Route
VAGINAL
Labeler
United Natural Foods, Inc. dba UNFI
Application
ANDA075915
Marketing category
ANDA
Marketing start
2016-03-08
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
Equaline 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
41163-032-54Equaline Tioconazole 11 in 1 POUCHOINTMENT13
41163-032-54Equaline Tioconazole 11 in 1 CARTONOINTMENT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-032EQUALINE TIOCONAZOLE 1 (TIOCONAZOLE) OINTMENT [UNITED NATURAL FOODS, INC. DBA UNFI]3Current NDC, Legacy NDC, 2 package rows20230826_e5bfbe25-9f90-41ff-b15a-9f9389de7052.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198380tioconazole 6.5 % Vaginal OintmentPSNe5bfbe25-9f90-41ff-b15a-9f9389de70523
198380tioconazole 0.065 MG/MG Vaginal OintmentSCDe5bfbe25-9f90-41ff-b15a-9f9389de70523
198380tioconazole 6.5 % Vaginal OintmentSYe5bfbe25-9f90-41ff-b15a-9f9389de70523

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41163-032-54411630032541 POUCH in 1 CARTON (41163-032-54) / 1 APPLICATOR in 1 POUCH / 4.6 g in 1 APPLICATOR1 pouch2016-03-080000-00-00NoNoCurrent