tioconazole 1

Product NDC
41250-426
11-digit product format
412500426
Labeler code
41250
Product ID
41250-426_56cd5431-08b5-4acd-b84f-fac04a7e5ffa
Type
HUMAN OTC DRUG
Nonproprietary name
Tioconazole
Dosage form
OINTMENT
Route
VAGINAL
Labeler
Meijer Distribution Inc
Application
ANDA075915
Marketing category
ANDA
Marketing start
2008-01-09
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
41250-426-54tioconazole 11 in 1 CARTONOINTMENT16
41250-426-54tioconazole 11 in 1 POUCHOINTMENT16

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-426TIOCONAZOLE 1 (TIOCONAZOLE) OINTMENT [MEIJER DISTRIBUTION INC]5Current NDC, Legacy NDC, 2 package rows20241220_7f0b0a4a-f8b5-4d86-afad-fe7e7eee2a31.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198380tioconazole 6.5 % Vaginal OintmentPSN7f0b0a4a-f8b5-4d86-afad-fe7e7eee2a316
198380tioconazole 0.065 MG/MG Vaginal OintmentSCD7f0b0a4a-f8b5-4d86-afad-fe7e7eee2a316
198380tioconazole 6.5 % Vaginal OintmentSY7f0b0a4a-f8b5-4d86-afad-fe7e7eee2a316

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41250-426-54412500426541 POUCH in 1 CARTON (41250-426-54) / 1 APPLICATOR in 1 POUCH / 4.6 g in 1 APPLICATOR1 pouch2008-01-090000-00-00NoNoCurrent