good sense tioconazole 1

Product NDC
0113-0426
11-digit product format
001130426
Labeler code
0113
Product ID
0113-0426_d8396310-fd7a-46be-b31c-41f0006605f2
Type
HUMAN OTC DRUG
Nonproprietary name
Tioconazole
Dosage form
OINTMENT
Route
VAGINAL
Labeler
L. Perrigo Company
Application
ANDA075915
Marketing category
ANDA
Marketing start
2019-10-22
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
good sense 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
0113-0426-54good sense tioconazole 11 in 1 CARTONOINTMENT12
0113-0426-54good sense tioconazole 11 in 1 POUCHOINTMENT12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-0426-54GM - Gram0113-0426f30e273b-c3c8-48f7-a2f5-98c023ffcabd12021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-0426GOOD SENSE TIOCONAZOLE 1 (TIOCONAZOLE) OINTMENT [L. PERRIGO COMPANY]2Current NDC, Legacy NDC, 2 package rows20231220_d39ac447-6e1d-4b77-90c1-a9a653661f42.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198380tioconazole 6.5 % Vaginal OintmentPSNd39ac447-6e1d-4b77-90c1-a9a653661f422
198380tioconazole 0.065 MG/MG Vaginal OintmentSCDd39ac447-6e1d-4b77-90c1-a9a653661f422
198380tioconazole 6.5 % Vaginal OintmentSYd39ac447-6e1d-4b77-90c1-a9a653661f422

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-0426-54001130426541 POUCH in 1 CARTON (0113-0426-54) / 1 APPLICATOR in 1 POUCH / 4.6 g in 1 APPLICATOR1 pouch2019-10-220000-00-00NoNoCurrent