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 8 of 25 · 493 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Foster and Thrive Lubricating Tears Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLStrategic Sourcing Services LLC0042337b-c22a-157a-e063-6394a90a202e2025-12-30WarningsExact identifier
unii: 6DC9Q167V3
CVS Lubricant Eye Drops OriginalPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCVSbb1ad35a-79ea-639f-e053-2995a90a96f32025-12-30WarningsExact identifier
unii: 6DC9Q167V3
Foster and Thrive Long Lasting Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLStrategic Sourcing Services LLC00546df0-17d8-0e3c-e063-6294a90ae7b22025-12-30WarningsExact identifier
unii: 6DC9Q167V3
Avenova Lubricant Eye Drops High PerformancePOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLNovaBay Pharmaceuticals, Inc.cd17f037-5aa5-0ef8-e053-2a95a90a39cb2025-12-30WarningsExact identifier
unii: 6DC9Q167V3
Equate Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLWalmart, Inc.deebaf7f-f20d-4d7f-e053-2a95a90a4b4f2025-12-30WarningsExact identifier
unii: 6DC9Q167V3
CorneaCare Recover Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCorneaCare Inc.1fd3a5ed-8963-5c8e-e063-6394a90a65272025-12-30WarningsExact identifier
unii: 6DC9Q167V3
Quality Choice Lubricant Eye Drops High PerformancePOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLChain Drug Marketing Assoc., Inc.0cd1b36a-a07a-a1db-e063-6294a90a59942025-12-30WarningsExact identifier
unii: 6DC9Q167V3
Quality Choice Lubricant Eye Drops Long LastingPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLChain Drug Marketing Assoc., Inc.0cd91c45-88a2-f88c-e063-6294a90ad1272025-12-30WarningsExact identifier
unii: 6DC9Q167V3
Quality Choice Eye WashWATERChain Drug Marketing Assoc., Inc.1fb8a109-351b-7039-e063-6394a90a73112025-12-30WarningsExact identifier
unii: 059QF0KO0R
Rite Aid Eye WashPURIFIED WATERRite Aid28a18e04-d735-a511-e063-6394a90af6bb2025-12-30WarningsExact identifier
unii: 059QF0KO0R
Archies Dry Eye ReliefPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLArchie's Remedies07da099b-6b7f-984d-e063-6294a90a12ac2025-12-30WarningsExact identifier
unii: 6DC9Q167V3
GestyraASCORBIC ACID, CHOLECALCIFEROL, THIAMINE, PYRIDOXAL PHOSPHATE, FOLIC ACID, METHYLCOBALAMIN, CALCIUM CARBONATE, FERROUS GLUCONATE, POTASSIUM IODIDEOncora Pharma LLCf10bf225-c125-4711-893a-78e15be815bb2025-12-30WarningsExact identifier
unii: PQ6CK8PD0R
TRICONTRICONNnodum Pharmaceuticalsd891ab47-4a05-4b5b-b372-7ddf91699c292025-12-29Adverse reactionsExact identifier
unii: PQ6CK8PD0R
OCUFRESHWATEROptics Laboratory Inc.b8e477a9-66b9-496b-92fb-3d4bbd7b36b52025-12-29WarningsExact identifier
unii: 059QF0KO0R
Kollourion Eyesalve EyewashPURIFIED WATER 98.3%Miracle Eye Pharmaceuticalsb56d2ab9-169b-b490-e053-2a95a90a80b32025-12-28WarningsExact identifier
unii: 059QF0KO0R
Walgreens LubricantPOLYETHYLENE GLYCOL 400, AND PROPYLENE GLYCOLWalgreens21dfe061-4538-2061-e063-6394a90a6e732025-12-19WarningsExact identifier
unii: 6DC9Q167V3
Sterile WaterWATERProPharma Distribution386a0a2f-4ff7-f128-e063-6294a90a7d4d2025-12-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STYE EYE RELIEF SERUMVITAMIN EGuangzhou Mizi Biotechnology Co., LTD.3f60193e-4b95-6759-e063-6394a90a991c2025-12-17WarningsExact identifier
unii: PQ6CK8PD0R
Ascorbic AcidASCORBIC ACIDFresenius Kabi USA, LLC1606e29f-0e80-4069-b688-daab9cbff20a2025-12-17Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
HemorrhoidAESCULUS HIPP, HAMAMELIS, ALOE, CALC PHOS, CARBO AN, CARBO VEG, LACHESIS, LYCOPODIUM, MURIATICUM AC, NITRICUM AC, NUX VOM, PAEONIA, RATANHIA, SEPIA, SULPHURNatural Creations, Incdb1b3aef-ba92-417c-b6f6-58e950ed42142025-12-16WarningsExact identifier
unii: QTT17582CB

Reported adverse events (FAERS/openFDA)#

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