FDA.reportPublic FDA data

NDC 51672-1330-03 - 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
51672-1330
Requested NDC
51672-1330-03
Package NDCs from labels
51672-1330-3, 51672-1330-03
Manufacturer
Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.
Effective date
2025-07-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Terconazole Vaginal Suppositories 80 mgSun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.2025-07-07HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-1330-3Terconazole3 in 1 DOSE PACKSUPPOSITORY36
51672-1330-3Terconazole1 in 1 CARTONSUPPOSITORY16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1330TERCONAZOLE SUPPOSITORY [TARO PHARMACEUTICALS U.S.A., INC.]5Current NDC, Legacy NDC, 2 package rows20241222_b4f50a11-bd39-4023-9145-2da60f6b085f.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TerconazoleACTIVE INGREDIENT0KJ2VE664UTERCONAZOLE SUPPOSITORY [TARO PHARMACEUTICALS U.S.A., INC.]3
TerconazoleACTIVE MOIETY0KJ2VE664UTERCONAZOLE SUPPOSITORY [TARO PHARMACEUTICALS U.S.A., INC.]3
butylated hydroxyanisoleINACTIVE INGREDIENTREK4960K2UTERCONAZOLE SUPPOSITORY [TARO PHARMACEUTICALS U.S.A., INC.]3
coconut oilINACTIVE INGREDIENTQ9L0O73W7LTERCONAZOLE SUPPOSITORY [TARO PHARMACEUTICALS U.S.A., INC.]3
palm kernel oilINACTIVE INGREDIENTB0S90M0233TERCONAZOLE SUPPOSITORY [TARO PHARMACEUTICALS U.S.A., 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 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HEALMUSZ HEALTHY FEETUREA 40% SALICYLIC ACID 2% GREEN TEA LEAFL 1% COCONUT OIL 1% HEALTHY FEETJiangxi Yudexi Pharmaceutical Co., LTD4a34b6de-03ec-3be4-e063-6294a90afb522026-06-14WarningsExact identifier
unii: Q9L0O73W7L
TerconazoleTERCONAZOLECosette Pharmaceuticals, Inc.38cd1718-6b3c-415d-a17f-7b399adb0ba22026-05-07Warnings, Adverse reactionsExact identifier
application number: ANDA077553
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
E.O.L.STILLINGIA SYLVATICA, ZINCUM GLUCONICUM, THIAMINUM HYDROCHLORICUM, FRAGARIA VESCA, NICOTINAMIDUM, RHEUM (PALMATUM), SEROTONIN (HYDROCHLORIDE), 5-HYDROXYTRYPTOPHAN, BETAINUM MURIATICUM, BIOTIN, CHOLINUM, CYSTEINUM, DL-METHIONINE, L-ALANINE, L-CYSTINE, L-GLUTAMIC ACID, L-GLUTAMINE, L-LYSINE, L-METHIONINE, L-SERINE, PARA-AMINOBENZOIC ACID, POTASSIUM GLUCONATE, THYMUS (SUIS), THYROIDINUM (SUIS), UBIDECARENONUM, VITAMIN D3, DOPAMINE HYDROCHLORIDE, LITHIUM BROMATUM, SQUALENE, VACCINIUM MACROCARPON, OXYTOCIN,InLight Creation, LLC.b317d812-d6ed-4a2f-93f7-08b12261cc992026-01-09WarningsExact identifier
unii: Q9L0O73W7L
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
application number: ANDA077553
ndc (package): 51672-1330-3
ndc (product): 51672-1330
ndc11 (package): 51672133003
rxcui: 198245
spl id: 3961c135-42f6-e0a2-e063-6394a90a2e33
spl set id: b4f50a11-bd39-4023-9145-2da60f6b085f
unii: 0KJ2VE664U
TerconazoleTERCONAZOLESun Pharmaceutical Industries, Inc.2b3923b5-0a97-428c-b8d2-4a3ceb3447a12025-05-27Warnings, Adverse reactionsExact identifier
unii: 0KJ2VE664U
AOAO Repair Foot CreamUREA,SALICYLIC ACID,TOCOPHEROL,CAMELLIA SINENSIS LEAF EXTRACT,ALOE VERA LEAF EXTRACT,COCOS NUCIFERA (COCONUT) OIL.Guangdong Junhui Biotechnology Co.,LTD21064e84-c827-ca82-e063-6394a90a6c652025-01-08WarningsExact identifier
unii: Q9L0O73W7L
Sulfur anti-mite shower gelSODIUM LAURETH SULFAT,DECYL GLUCOSIDE,PALM KERNELAMIDE DEA,COCAMIDOPROPYL BETAINE,LONICERA JAPONICA(HONEYSUCKLE) FLOWER EXTRACT,COLLOIDAL SULFUR.Guangdong Junhui Biotechnology Co., Ltd251ee057-1adf-bc97-e063-6394a90acdd32025-01-08WarningsExact identifier
unii: B0S90M0233
TerconazoleTERCONAZOLENuCare Pharmaceuticals,Inc.71c13149-396e-edc6-e053-2a95a90af50c2024-12-24Warnings, Adverse reactionsExact identifier
unii: 0KJ2VE664U
TerconazoleTERCONAZOLEPadagis Israel Pharmaceuticals Ltd207e9cf2-e8ec-43d7-9c11-46283c9cdb372024-09-30Warnings, Adverse reactionsExact identifier
rxcui: 198245
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
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