FDA.reportPublic FDA data

NDC 69339-159-01 - Itraconazole Oral

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
69339-159
Requested NDC
69339-159-01
Package NDCs from labels
69339-159-01, 69339-159-17
Manufacturer
Natco Pharma USA LLC | Annora Pharma Private Limited
Effective date
2023-08-05
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Itraconazole Oral - Natco Pharma USA LLC | Annora Pharma Private LimitedNatco Pharma USA LLC | Annora Pharma Private Limited2023-08-05HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69339-159-01Itraconazole Oral10 mL in 1 CUP, UNIT-DOSESOLUTION102
69339-159-17Itraconazole Oral40 in 1 BOX, UNIT-DOSESOLUTION402

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69339-159ITRACONAZOLE ORAL (ITRACONAZOLE) SOLUTION [NATCO PHARMA USA LLC]2Current NDC, Legacy NDC, 2 package rows20230902_da63870d-b426-4e49-9591-5bb51f962e66.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69339-159-01ML - Milliliter69339-1596c2811ce-c431-4a7f-a075-b13765858a8e12022-05-04
69339-159-17ML - Milliliter69339-159ddd59faa-e4cb-43f8-b1d4-19964974f5a012022-05-04

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 7 of 25 · 493 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CitraNatal 90 DHAVITAMIN C, CALCIUM, IRON, VITAMIN D3, VITAMIN E, THIAMIN, RIBOFLAVIN, NIACINAMIDE, VITAMIN B6, FOLIC ACID, IODINE, ZINC, COPPER, DOCUSATE SODIUMMission Pharmacal Company81e639d7-352e-4eaa-87d9-582da68b97282026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
Cellular Oxygenator Drops 2095CELLULAR OXYGENATOR DROPSProfessional Complementary Health Formulas5aba4627-6078-4c9e-93ee-690cfe3439cf2026-01-08WarningsExact identifier
unii: PQ6CK8PD0R
Mucolytic Drainage Liquescence 3017MUCOLYTIC DRAINAGE LIQUESCENCEProfessional Complementary Health Formulasf6dd9b87-053d-4d88-b0e4-7693f5524ce72026-01-08WarningsExact identifier
unii: PQ6CK8PD0R
Anti-Hives Drops 2004ANTI-HIVES DROPSProfessional Complementary Health Formulas45ae94f2-4310-41d3-8532-ef9b132b32822026-01-08WarningsExact identifier
unii: PQ6CK8PD0R
Abdominal Pain Drops 2051ABDOMINAL PAIN DROPSProfessional Complementary Health Formulasf1b1dde6-bb37-4774-a58c-b4f648f9c2b52026-01-08WarningsExact identifier
unii: QTT17582CB
Pain Formula Drops 2046PAIN FORMULA DROPSProfessional Complementary Health Formulas4456c022-5aac-49b4-b976-b629525f3d492026-01-08WarningsExact identifier
unii: PQ6CK8PD0R
Ferralet 90IRON, FOLIC ACID, CYANOCOBALAMIN, ASCORBIC ACID, AND DOCUSATE SODIUMMission Pharmacal Company0be2918e-55b3-4c66-aba0-09099a1c77702026-01-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
Eye CleanEYE WASHHART Health41f53e2e-c2bc-4bf1-a541-3bcb2cf630022025-12-31WarningsExact identifier
unii: 059QF0KO0R
LunaviraMULTIVITAMINOncora Pharma, LLC474780d5-dd88-8f1a-e063-6294a90a03dc2025-12-31Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
teeth and gumsCALC FLUORICA, CALC PHOS, FERRUM PHOS, KALI PHOS, MAG PHOS, MALUS PUMILA, FLOS, ROCK WATER, ULEX EUROPAEUS, FLOSSiddha Flower Essences LLC926c79d5-d270-4c0d-aca9-b58571c24f3a2025-12-31WarningsExact identifier
unii: 059QF0KO0R
lung and sinusCALC PHOS, FERRUM PHOS, GENTIANELLA AMARELLA, FLOS, KALI MUR, KALI PHOS, KALI SULPH, ROCK WATER, ROSE CANINA, FLOSSiddha Flower Essences LLC9f7c949f-21bc-473c-ab8d-24837893fccc2025-12-31WarningsExact identifier
unii: 059QF0KO0R
Signature Care Eye Drops High PerformancePOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLBetter Living Brands LLC6f1f4f58-3208-4b06-9afb-c4beeed093142025-12-30WarningsExact identifier
unii: 6DC9Q167V3
Target Lubricant Eye Drops High PerformancePOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLTarget Corporation6c449374-8847-4c4a-9073-1951ff31d4042025-12-30WarningsExact identifier
unii: 6DC9Q167V3
Target Lubricant Eye Drops High PerformancePOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLTarget Corporationddc15dac-fbd8-42fa-80db-79f49fc6b9eb2025-12-30WarningsExact identifier
unii: 6DC9Q167V3
CVS Hydration Eye DropsPOLYETYLENE GLYCOL 400, PROPYLENE GLYCOLCVSecab8fa3-6575-0dde-e053-2a95a90abd612025-12-30WarningsExact identifier
unii: 6DC9Q167V3
GoodSense Ultra Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLGeiss, Destin & Dunn, Inc.9b45ebb5-c43b-c9fb-e053-2a95a90a34112025-12-30WarningsExact identifier
unii: 6DC9Q167V3
Medics Choice Fresh and Soothe Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLKC Pharmaceuticals, Inc.1f65b91a-4eac-65c2-e063-6394a90a02952025-12-30WarningsExact identifier
unii: 6DC9Q167V3
DG Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLDolgencorp LLC9cb27899-6c36-3c37-e053-2995a90a1d432025-12-30WarningsExact identifier
unii: 6DC9Q167V3
Publix High Performance Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLPublix Super Markets, Inc.9b402aa8-87cb-3928-e053-2995a90afa3c2025-12-30WarningsExact identifier
unii: 6DC9Q167V3
Health Mart Lubricating TearsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLStrategic Sourcing Services LLCc8be678f-2b4a-4d39-9cb4-910d36d721742025-12-30WarningsExact identifier
unii: 6DC9Q167V3

Reported adverse events (FAERS/openFDA)#

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