FDA.reportPublic FDA data

NDC 45802-717-00 - Terconazole

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
45802-717
Requested NDC
45802-717-00
Package NDCs from labels
45802-717-00, 45802-717-08
Manufacturer
Padagis Israel Pharmaceuticals Ltd
Effective date
2026-08-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Terconazole - Padagis Israel Pharmaceuticals LtdPadagis Israel Pharmaceuticals Ltd2026-08-11HUMAN PRESCRIPTION DRUG LABEL

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 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 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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 ยท 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TerconazoleTERCONAZOLEPadagis Israel Pharmaceuticals Ltd207e9cf2-e8ec-43d7-9c11-46283c9cdb372026-08-11Warnings, Adverse reactionsExact identifier
application number: ANDA077149
ndc (package): 45802-717-00
ndc (package): 45802-717-08
ndc (product): 45802-717
ndc11 (package): 45802071700
rxcui: 198245
spl id: 006c6bda-594f-46ce-ba64-d075022ed4b4
spl set id: 207e9cf2-e8ec-43d7-9c11-46283c9cdb37
unii: 0KJ2VE664U
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: C9H2L21V7U
TerconazoleTERCONAZOLECosette Pharmaceuticals, Inc.38cd1718-6b3c-415d-a17f-7b399adb0ba22026-05-07Warnings, Adverse reactionsExact identifier
rxcui: 198245
unii: 0KJ2VE664U
Terconazole Vaginal Cream 0.8%TERCONAZOLEE. Fougera & Co. a division of Fougera Pharmaceuticals, LLCf59448bd-f730-46d2-a785-c2d6205579ff2026-01-28Warnings, Adverse reactionsExact identifier
unii: 0KJ2VE664U
TerconazoleTERCONAZOLEE. Fougera & Co. a division of Fougera Pharmaceuticals, LLC10e84353-93d2-461d-8b79-e9294df047ae2026-01-28Warnings, Adverse reactionsExact identifier
unii: 0KJ2VE664U
SmoflipidSMOFLIPIDFresenius Kabi USA, LLCe0e9d917-ff6f-488e-a6a8-0ad59dd17d802025-08-15Warnings, Adverse reactionsExact identifier
unii: C9H2L21V7U
TerconazoleTERCONAZOLESun Pharmaceutical Industries, Inc.6d7a8fd6-7837-427e-9b18-89e33351b05e2025-07-07Warnings, Adverse reactionsExact identifier
unii: 0KJ2VE664U
TerconazoleTERCONAZOLESun Pharmaceutical Industries, Inc.b4f50a11-bd39-4023-9145-2da60f6b085f2025-07-07Warnings, Adverse reactionsExact identifier
rxcui: 198245
unii: 0KJ2VE664U
TerconazoleTERCONAZOLESun Pharmaceutical Industries, Inc.2b3923b5-0a97-428c-b8d2-4a3ceb3447a12025-05-27Warnings, Adverse reactionsExact identifier
unii: 0KJ2VE664U
TerconazoleTERCONAZOLENuCare Pharmaceuticals,Inc.71c13149-396e-edc6-e053-2a95a90af50c2024-12-24Warnings, Adverse reactionsExact identifier
unii: 0KJ2VE664U
TerconazoleTERCONAZOLEA-S Medication Solutionsb922feb5-cd85-4f13-9a18-913e58f8da832023-12-09Warnings, Adverse reactionsExact identifier
unii: 0KJ2VE664U
TerconazoleTERCONAZOLEA-S Medication Solutionse0a5e163-741f-4f5e-9d2e-b733f9879c992023-10-31Warnings, Adverse reactionsExact identifier
unii: 0KJ2VE664U
ANUBISMEDHA HYALURONICANUBIS COSMETICS SLeac771e2-4c1b-3808-e053-2995a90ac5fc2023-09-05WarningsExact identifier
unii: C9H2L21V7U
Anubis Barcelona Vital LineHYDROLYZED ELASTIN, HYDROLYSED COLLAGEN, COCOGLYCERIDESANUBIS COSMETICS SLebe024f7-7c45-ad60-e053-2995a90a45d62023-09-01WarningsExact identifier
unii: C9H2L21V7U
Anubis Barcelona Vital LineHYDROLYZED COLLAGENANUBIS COSMETICS SLf564bbf0-3b5c-4a81-e053-2a95a90a7ea62023-08-29WarningsExact identifier
unii: C9H2L21V7U
Terconazole Vaginal Cream 0.8%TERCONAZOLEA-S Medication Solutions9b1c38ac-ebf3-471c-bcdf-1ff8ad197f912023-01-03Warnings, Adverse reactionsExact identifier
unii: 0KJ2VE664U
TerconazoleTERCONAZOLEA-S Medication Solutions1e32bf0d-2a93-44ac-ae28-8d34e10380c02023-01-03Warnings, Adverse reactionsExact identifier
unii: 0KJ2VE664U

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.