FDA.reportPublic FDA data

NDC 85160-100-01 - Turkfleks %0.5 Metronidazole Infusion Solution

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
85160-100
Requested NDC
85160-100-01
Package NDCs from labels
85160-100-01, 85160-100-10
Manufacturer
TURK ILAC VE SERUM SANAYI ANONIM SIRKETI
Effective date
2025-03-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
%0.5 Metronidazole Infusion Solution - TURK ILAC VE SERUM SANAYI ANONIM SIRKETITURK ILAC VE SERUM SANAYI ANONIM SIRKETI2025-03-30HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85160-100-01Turkfleks %0.5 Metronidazole Infusion Solution100 mL in 1 BAGINJECTION, SOLUTION1001
85160-100-10Turkfleks %0.5 Metronidazole Infusion Solution50 in 1 BOXINJECTION, SOLUTION501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85160-100TURKFLEKS %0.5 METRONIDAZOLE INFUSION SOLUTION (%0.5 METRONIDAZOLE INFUSION SOLUTION) INJECTION, SOLUTION [TURK ILAC VE SERUM SANAYI ANONIM SIRKETI]12 package rows20250403_316c5c93-5922-5146-e063-6394a90a694b.zip

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 8 · 158 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
metronidazole vaginalMETRONIDAZOLESaptalis Pharmaceuticals LLC08abacec-3b6a-43e7-bfaa-2041d87a26c72025-01-14Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
LIKMEZMETRONIDAZOLE ORALKesin Pharma Corporation23927a8b-1641-4104-aa85-d7b7bf4ebb9d2024-12-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
MetronidazoleMETRONIDAZOLENuCare Pharmaceuticals,Inc.a860b097-7447-a3b7-e053-2995a90a4bfd2024-12-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
MetronidazoleMETRONIDAZOLEQuality Care Products LLC0d8125d6-173f-4498-85a9-a1323c7a0e422024-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
MetronidazoleMETRONIDAZOLEViona Pharmaceuticals Inc93299502-6cb0-48a4-8190-50fef74bdbee2024-12-06Adverse reactionsExact identifier
unii: 140QMO216E
METRONIDAZOLEMETRONIDAZOLEPrasco Laboratoriesa6ce81f5-a5c6-44d7-b5f0-61d0530345bd2024-11-07Adverse reactionsExact identifier
unii: 140QMO216E
MetronidazoleMETRONIDAZOLEBryant Ranch Prepacke1e7e127-e99e-80e9-1606-71261658b0c12024-11-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
MetronidazoleMETRONIDAZOLEBryant Ranch Prepack2fa14353-45df-429c-8759-7d66a65f08f02024-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
METRONIDAZOLEMETRONIDAZOLEMayne Pharma Inc.567c7c0c-ffc1-47c1-b0fb-8715bf3d76b92024-10-31Adverse reactionsExact identifier
unii: 140QMO216E
MetronidazoleMETRONIDAZOLEMayne Pharma Inc.3c25a3f9-52fc-448e-a044-f63b9dadcd4a2024-10-31Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
MetronidazoleMETRONIDAZOLEBryant Ranch Prepack8522493d-0a18-49dd-8d49-bd159f6ee3322024-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
MetronidazoleMETRONIDAZOLEBryant Ranch Prepack92e58420-1d99-4a92-b1f3-a7f791ca71872024-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
MetronidazoleMETRONIDAZOLEA-S Medication Solutionse6ece591-38fa-4016-bd62-d31a3e5a8da32024-10-21Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
METRONIDAZOLEMETRONIDAZOLEAurobindo Pharma Limitedd9d4caed-2fa9-4b46-9b7c-d60ec3b879b22024-10-17Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
MetronidazoleMETRONIDAZOLEBryant Ranch Prepackdaee5e69-aa86-470b-81b7-3074d27fc8472024-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
metronidazoleMETRONIDAZOLEMayne Pharma Inc.5099691f-f216-4ac1-b057-99a845cc770f2024-09-30Adverse reactionsExact identifier
unii: 140QMO216E
MetronidazoleMETRONIDAZOLERising Pharma Holdings, Inc.93e4f174-4fe0-4cfd-a0cf-d0963e0821072024-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
MetronidazoleMETRONIDAZOLEBryant Ranch Prepack8e1f507b-22fa-4033-9b3e-5435f20ace662024-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
MetronidazoleMETRONIDAZOLEAurobindo Pharma Limitedf68397ee-67db-472e-8607-4300064e37df2024-09-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
metronidazoleMETRONIDAZOLEViona Pharmaceuticals Inc0f108035-d2ab-49c1-9f8d-daae11f0efe02024-08-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 140QMO216E

Reported adverse events (FAERS/openFDA)#

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