FDA.reportPublic FDA data

Terconazole

Product NDC
45802-717
11-digit product format
458020717
Labeler code
45802
Product ID
45802-717_5def32af-7e22-4dbf-b0cd-aca45e2987b0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Terconazole
Dosage form
SUPPOSITORY
Route
VAGINAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
ANDA077149
Marketing category
ANDA
Marketing start
2006-08-28
Substance
TERCONAZOLE
Active strength
80 mg/1
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
Terconazole
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TERCONAZOLE80 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0KJ2VE664U
Rxcui198245

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a1f2acc3-46a1-8c88-4468-5826c2e9fea6Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45802-717-00Terconazole1 in 1 BLISTER PACKSUPPOSITORY114
45802-717-08Terconazole3 in 1 CARTONSUPPOSITORY314

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-717-00EA - Each45802-7172d1becfb-6670-41a8-846b-9532b30b877212019-12-10
45802-717-08EA - Each45802-7173ee857ff-9984-40ea-873a-73ee5f1db07012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TERCONAZOLEACTIVE INGREDIENT0KJ2VE664UTERCONAZOLE SUPPOSITORY [PERRIGO NEW YORK INC]3
TERCONAZOLEACTIVE MOIETY0KJ2VE664UTERCONAZOLE SUPPOSITORY [PERRIGO NEW YORK INC]3
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UTERCONAZOLE SUPPOSITORY [PERRIGO NEW YORK INC]3
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UTERCONAZOLE SUPPOSITORY [PERRIGO NEW YORK INC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-717TERCONAZOLE SUPPOSITORY [PADAGIS ISRAEL PHARMACEUTICALS LTD]14Current NDC, Legacy NDC, 2 package rows20250413_207e9cf2-e8ec-43d7-9c11-46283c9cdb37.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198245terconazole 80 MG Vaginal InsertPSN207e9cf2-e8ec-43d7-9c11-46283c9cdb3714
198245terconazole 80 MG Vaginal InsertSCD207e9cf2-e8ec-43d7-9c11-46283c9cdb3714

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-717-00458020717001 in 1 BLISTER PACKHistorical
45802-717-08458020717083 BLISTER PACK in 1 CARTON (45802-717-08) / 1 SUPPOSITORY in 1 BLISTER PACK (45802-717-00) 3 blister pack2006-08-280000-00-00NoNoCurrent