FDA.reportPublic FDA data

NDC 65162-087-13 - Itraconazole

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
65162-087
Requested NDC
65162-087-13
Package NDCs from labels
65162-087-74, 65162-087-13, 65162-087-34
Manufacturer
Amneal Pharmaceuticals LLC | Amneal Pharmaceuticals, LLC
Effective date
2026-08-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Itraconazole - Amneal Pharmaceuticals LLC | Amneal Pharmaceuticals, LLCAmneal Pharmaceuticals LLC | Amneal Pharmaceuticals, LLC2026-08-03HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65162-087-13Itraconazole10 mL in 1 CUP, UNIT-DOSESOLUTION1019
65162-087-34Itraconazole10 in 1 TRAYSOLUTION1019
65162-087-74Itraconazole150 mL in 1 BOTTLE, GLASSSOLUTION15019

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-087ITRACONAZOLE SOLUTION [AMNEAL PHARMACEUTICALS LLC]19Current NDC, Legacy NDC, 3 package rows20250119_43ded1aa-f825-40fe-aa9a-addd36a07f06.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-087-74ML - Milliliter65162-0875e6d1ea6-047c-4c09-9a67-7d82ad7479f412018-10-11

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 16 · 305 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: 6DC9Q167V3
Rohto Preservative Free Dry AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Companyf4b1974c-2412-45f6-b79d-88b8a0bcb6082026-08-18WarningsExact identifier
unii: 6DC9Q167V3
Rohto Dry-AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Company8ea5c6c9-48f4-406a-a2cb-9280c546d87d2026-08-18WarningsExact identifier
unii: 6DC9Q167V3
ItraconazoleITRACONAZOLERising Pharma Holdings, Inc.6df5ff94-47ba-4881-abb4-b321e35a69552026-08-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 304NUG5GF4
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
SYSTANE HYDRATION PF PRESERVATIVE FREEPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.8936f66f-10fe-44ab-a26e-dd8b05dfa9972026-08-10WarningsExact identifier
unii: 6DC9Q167V3
Systane Pro PFPROPYLENE GLYCOLAlcon Laboratories, Inc.23b3515f-fbe5-4398-b2df-8b2eccdd01e22026-08-10WarningsExact identifier
unii: 6DC9Q167V3
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Leader Lubricant Eye Drops 30ctPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCARDINAL HEALTH 110, LLC. DBA LEADER8df69f2c-40c4-245c-e053-2a95a90a54062026-08-05WarningsExact identifier
unii: 6DC9Q167V3
ItraconazoleITRACONAZOLEAmneal Pharmaceuticals LLC43ded1aa-f825-40fe-aa9a-addd36a07f062026-08-03Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA205573
ndc (package): 65162-087-34
ndc (package): 65162-087-74
ndc (package): 65162-087-13
ndc (product): 65162-087
ndc11 (package): 65162008713
rxcui: 348506
spl id: 4e655ee7-8fc4-4b54-aa43-89aafb2077dc
spl set id: 43ded1aa-f825-40fe-aa9a-addd36a07f06
unii: 304NUG5GF4
ITRACONAZOLEITRACONAZOLEAlembic Pharmaceuticals Inc.23126370-8d6a-4027-bd8f-860e2776ba3a2026-07-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 304NUG5GF4
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ItraconazoleITRACONAZOLETorrent Pharmaceuticals Limitedb1274d78-1096-4ae3-8299-a2e94eaa0ea52026-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 304NUG5GF4
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
NeutraflushEYEWASH STATION ADDITIVE CONCENTRATEAero Healthcare1d9ff2ef-9c9b-f367-e063-6294a90afa0e2026-07-24WarningsExact identifier
unii: 6DC9Q167V3
ItraconazoleITRACONAZOLEAmneal Pharmaceuticals LLC2ab38a8a-3708-4b97-9f7f-8e554a15348d2026-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 304NUG5GF4
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
FUNGAL NAIL TREATMENT kit .cream.PSEUDOLARIX AMABILIS BARK 1%GETHSEMANE BRANCH CORPORATION56c9d9fa-09ad-e26a-e063-6394a90a0ed92026-07-17WarningsExact identifier
unii: 6DC9Q167V3

Reported adverse events (FAERS/openFDA)#

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