TIOCONAZOLE 1

Product NDC
21130-781
11-digit product format
211300781
Labeler code
21130
Product ID
21130-781_a442fa1c-3af7-4388-bbf4-0a14775ff1ca
Type
HUMAN OTC DRUG
Nonproprietary name
Tioconazole
Dosage form
OINTMENT
Route
VAGINAL
Labeler
Safeway
Application
ANDA075915
Marketing category
ANDA
Marketing start
2026-05-01
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
21130-781-54TIOCONAZOLE 11 in 1 POUCHOINTMENT12
21130-781-54TIOCONAZOLE 11 in 1 CARTONOINTMENT12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198380tioconazole 6.5 % Vaginal OintmentPSN5b7d477e-835b-4557-9a05-c5959dbc803e2
198380tioconazole 0.065 MG/MG Vaginal OintmentSCD5b7d477e-835b-4557-9a05-c5959dbc803e2
198380tioconazole 6.5 % Vaginal OintmentSY5b7d477e-835b-4557-9a05-c5959dbc803e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
21130-781-54211300781541 POUCH in 1 CARTON (21130-781-54) / 1 APPLICATOR in 1 POUCH / 4.6 g in 1 APPLICATOR1 pouch2026-05-01NoNoCurrent