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 4 of 8 · 158 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MetronidazoleMETRONIDAZOLERedpharm Drug300b51d0-8fca-24ef-e063-6294a90ad2b92025-12-23Adverse reactionsExact identifier
unii: 140QMO216E
MetronidazoleMETRONIDAZOLERedpharm Drug32523df9-8c47-200f-e063-6294a90ac8902025-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
MetronidazoleMETRONIDAZOLEChartwell RX, LLC40509b3c-b725-400c-abe5-d6d5714d405d2025-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
MetronidazoleMETRONIDAZOLEA-S Medication Solutions60ad086d-6f54-4134-b608-53a6ff571ff82025-12-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
MetronidazoleMETRONIDAZOLEA-S Medication Solutions2a5af710-dbf7-41c1-9b3a-35e69b3fa4ab2025-12-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
MetronidazoleMETRONIDAZOLEA-S Medication Solutions9a18debb-3bb8-4b23-949b-aaa0f3b621912025-12-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
VandazoleMETRONIDAZOLEUpsher-smith Laboratories, LLC27d71471-8f89-4a1e-8c55-020a589614542025-12-02Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
MetronidazoleMETRONIDAZOLECivica, Inc.902ab25b-d493-495a-884e-96b080e9f72d2025-11-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311683
unii: 140QMO216E
MetronidazoleMETRONIDAZOLEHospira, Inc.49360d6f-c8b3-420e-af75-154cf7b052552025-11-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311683
unii: 140QMO216E
Bismuth subcitrate potassium, Metronidazole, Tetracycline hydrochlorideBISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE, TETRACYCLINE HYDROCHLORIDEIngenus Pharmaceuticals, LLC4c7f024d-ba26-43cf-a36f-597e2168cd9f2025-11-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
metronidazoleMETRONIDAZOLEBryant Ranch Prepackac7e80ce-6174-4246-a955-a92adc5165712025-10-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
metronidazole vaginalMETRONIDAZOLEA-S Medication Solutions58ce793b-9b6a-4cd7-94ae-215dbf9e2ef72025-10-29Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
MetronidazoleMETRONIDAZOLEPD-Rx Pharmaceuticals, Inc.353b7f5b-4bbc-4ec9-84ba-d82656ea18112025-10-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
Metronidazole Vaginal Gel, 0.75%METRONIDAZOLEEncube Ethicals, Inc.63ed1e7e-d264-4e35-af83-ec37fa5b06d12025-10-09Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
metronidazoleMETRONIDAZOLEPD-Rx Pharmaceuticals, Inc.8f1de4ca-a005-4ca9-a43a-380429c80d6f2025-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
MetronidazoleMETRONIDAZOLEPD-Rx Pharmaceuticals, Inc.4cdd7ac5-a52c-4766-afeb-1b5e567a328c2025-10-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
MetronidazoleMETRONIDAZOLEPD-Rx Pharmaceuticals, Inc.aea4e2a1-2089-40dc-9eee-deaab4f213972025-10-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
MetronidazoleMETRONIDAZOLEPD-Rx Pharmaceuticals, Inc.b85bdc1f-1ffb-40d5-a407-e8de2891996d2025-10-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
MetronidazoleMETRONIDAZOLEBryant Ranch Prepack1abb2827-67e4-43c0-9762-8261f480fc3a2025-09-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
MetronidazoleMETRONIDAZOLECadila Pharmaceuticals Limited0c55bfc1-770a-4cce-a5dd-446000b24f162025-09-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 140QMO216E

Reported adverse events (FAERS/openFDA)#

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