FDA.reportPublic FDA data

NDC 67707-043-99 - Antara

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
67707-043
Requested NDC
67707-043-99
Package NDCs from labels
67707-043-30, 67707-043-99
Manufacturer
Oscient Pharmaceuticals Corporation
Effective date
2008-01-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Antara - Oscient Pharmaceuticals CorporationOscient Pharmaceuticals Corporation2008-01-30HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67707-043-30Antara30 in 1 BOTTLE, PLASTICCAPSULE302
67707-043-99Antara100 in 1 BOTTLE, PLASTICCAPSULE1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67707-043ANTARA (FENOFIBRATE) CAPSULE [OSCIENT PHARMACEUTICALS CORPORATION]22 package rows20080208_ACCA05AB-185B-41A6-9CE2-783FC3C3CF96.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
fenofibrateACTIVE INGREDIENTU202363UOSANTARA (FENOFIBRATE) CAPSULE [OSCIENT PHARMACEUTICALS CORPORATION]2
fenofibrateACTIVE MOIETYU202363UOSANTARA (FENOFIBRATE) CAPSULE [OSCIENT PHARMACEUTICALS CORPORATION]2
dimethiconeINACTIVE INGREDIENTANTARA (FENOFIBRATE) CAPSULE [OSCIENT PHARMACEUTICALS CORPORATION]2
hypromelloseINACTIVE INGREDIENTANTARA (FENOFIBRATE) CAPSULE [OSCIENT PHARMACEUTICALS CORPORATION]2
simethiconeINACTIVE INGREDIENTANTARA (FENOFIBRATE) CAPSULE [OSCIENT PHARMACEUTICALS CORPORATION]2
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JANTARA (FENOFIBRATE) CAPSULE [OSCIENT PHARMACEUTICALS CORPORATION]2
sugar spheresINACTIVE INGREDIENTANTARA (FENOFIBRATE) CAPSULE [OSCIENT PHARMACEUTICALS CORPORATION]2
talcINACTIVE INGREDIENT7SEV7J4R1UANTARA (FENOFIBRATE) CAPSULE [OSCIENT PHARMACEUTICALS CORPORATION]2

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 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FenofibrateFENOFIBRATESun Pharmaceutical Industries, Inc.2083f5d9-92f2-4c64-b996-fabbd6946ea02026-06-19Warnings, Adverse reactionsExact identifier
rxcui: 483425
rxcui: 483427
FenofibrateFENOFIBRATEPD-Rx Pharmaceuticals, Inc.2f5cee5c-ec55-4e9b-9d54-e7f2f052130e2026-02-26Warnings, Adverse reactionsExact identifier
rxcui: 483425
FenofibrateFENOFIBRATEApotex Corp.68024459-987a-9cf4-f539-4959093bc9f02025-10-29Warnings, Adverse reactionsExact identifier
rxcui: 483425
rxcui: 483427
ANTARAFENOFIBRATELupin Pharmaceuticals, Inc.24790a18-0291-4b88-a724-acac43b616ce2025-10-01Warnings, Adverse reactionsExact identifier
rxcui: 483425
rxcui: 483427
rxcui: 578799
rxcui: 578797
FenofibrateFENOFIBRATELupin Pharmaceuticals, Inc.37b25526-0bd0-4459-a4be-f3a6893506f92025-06-02Warnings, Adverse reactionsExact identifier
rxcui: 483425
rxcui: 483427
FenofibrateFENOFIBRATEDr. Reddy's Laboratories Limited16ea8ce4-8c1c-4111-509e-86aa688d89a02018-12-28Warnings, Adverse reactionsExact identifier
rxcui: 483425
rxcui: 483427
1F7FF2DA-E426-6A00-B6EC-0811C277E4B7ACCA05AB-185B-41A6-9CE2-783FC3C3CF962008-01-30Warnings, Adverse reactionsExact identifier
spl id: 1F7FF2DA-E426-6A00-B6EC-0811C277E4B7
spl set id: ACCA05AB-185B-41A6-9CE2-783FC3C3CF96

Reported adverse events (FAERS/openFDA)#

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