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 6 of 25 · 493 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AfloraMULTIVITAMINOncora Pharma, LLC38e463d1-f608-7cb5-e063-6294a90a4abb2026-02-12Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
FolixiaMULTIVITAMINOncora Pharma, LLC413945b5-116b-d8b6-e063-6394a90a55e82026-02-12Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
NutralynMULTIVITAMINOncora Pharma, LLC33da017b-1e8c-d41c-e063-6394a90aab8c2026-02-12Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
FolatenMULTIVITAMINOncora Pharma, LLC93086235-2c33-424d-b0c3-2130319885812026-02-12Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
Floravita MiniFLORAVITA MINIFlorrax Pharmaceutical682bda57-21e0-47df-9596-78846d4d97c02026-02-12Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
Droptics Performance Eye DropsNAPHAZOLINE HYDROCHLORIDE, PROPYLENE GLYCOLDroptics LLC20fd6822-a7fd-4593-92bb-0a07260893e22026-02-09WarningsExact identifier
unii: 6DC9Q167V3
Vitamin C SerumVITAMIN CFlexiGo Inc496e7d41-2176-7b0c-e063-6394a90a98f12026-01-28WarningsExact identifier
unii: PQ6CK8PD0R
Dialyvite 5000ASCORBIC ACID, TOCOPHERYL ACID SUCCINATE, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID, ZINC, SELENIUMHillestad Pharmaceuticals USA97791f73-e0c5-45a6-8aed-f456a5466eaf2026-01-27Adverse reactionsExact identifier
unii: PQ6CK8PD0R
DialyviteASCORBIC ACID, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACIDHillestad Pharmaceuticals USA7a5e6dd6-5687-44bb-8964-841961c0e64a2026-01-27Adverse reactionsExact identifier
unii: PQ6CK8PD0R
Dialyvite Supreme DASCORBIC ACID, CHOLECALCIFEROL, ALPHA-TOCOPHEROL, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, FOLIC ACID, COBALAMIN, BIOTIN, PANTOTHENIC ACID, ZINC, SELENIUMHillestad Pharmaceuticals USA46fc3acf-1e6d-4830-ae9a-abd9c1132fca2026-01-27Adverse reactionsExact identifier
unii: PQ6CK8PD0R
INSULIN DILUTING MEDIUM FOR KirstyWATERBiocon Biologics Inc.3db1d482-7e1f-aec6-79ef-3f305b4d82772026-01-20Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Artifical TearsGLYCERIN AND PROPYLENE GLYCOLWal-Mart Stores Inc99cfea82-afb8-4c5f-ac0c-492204a42c082026-01-20WarningsExact identifier
unii: 6DC9Q167V3
Walgreens Sterile Soothing Eye WashPURIFIED WATERWalgreensa62e3294-abd6-48dc-81b1-62a809bdc9682026-01-14WarningsExact identifier
unii: 059QF0KO0R
ItraconazoleITRACONAZOLEAvPAK68165d90-953c-e2f5-e053-2a91aa0ada252026-01-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 304NUG5GF4
Pyrogenium Combination 9239PYROGENIUM COMBINATIONProfessional Complementary Health Formulas8b869987-bfd2-4451-a2a8-ce3a92e201f22026-01-08WarningsExact identifier
unii: PQ6CK8PD0R
C-Balance Liquescence 3022C-BALANCE LIQUESCENCEProfessional Complementary Health Formulase209f9bc-9d85-4ab7-8d41-187b65c548722026-01-08WarningsExact identifier
unii: PQ6CK8PD0R
Endotoxin Terrain Drops 2143ENDOTOXIN TERRAIN DROPSProfessional Complementary Health Formulas58842566-005a-48b5-973d-20cde2fbd7012026-01-08WarningsExact identifier
unii: QTT17582CB
Lubricant Eye Drops SolutionPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAvPAKf5743b38-e3d2-a065-e053-2995a90a4b9a2026-01-08WarningsExact identifier
unii: 6DC9Q167V3
Plus Rinse Emergency EyewashPURIFIED WATERINNOVATIVE SAFETY SUPPLY INC.b3f47d26-39e4-4aea-bb92-358def52b6522026-01-08WarningsExact identifier
unii: 059QF0KO0R
pH Neutral Emergency EyewashWATERINNOVATIVE SAFETY SUPPLY INC.29a1bd1e-d0dd-478f-e063-6394a90ab0aa2026-01-08WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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