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 3 of 8 · 158 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MetronidazoleMETRONIDAZOLEBluePoint Laboratories3cf021b6-5794-4a86-b09d-bece0ba8b3022026-02-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
MetronidazoleMETRONIDAZOLEViona Pharmaceuticals Inc40a8c59b-a46d-4e5b-bd38-330cdbc1022c2026-02-19Adverse reactionsExact identifier
unii: 140QMO216E
MetronidazoleMETRONIDAZOLEZydus Lifesciences Limitedaa7fc40e-64a1-4155-bb39-77ed7b7f2e672026-02-19Exact identifier
unii: 140QMO216E
metronidazole vaginalMETRONIDAZOLEREMEDYREPACK INC.b8fbd105-90ae-4af4-9313-61834aaf4a2c2026-02-13Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
metronidazole vaginalMETRONIDAZOLEREMEDYREPACK INC.b07f42dd-75d4-499a-984f-c06894ff3a452026-02-12Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
metronidazoleMETRONIDAZOLESportpharm LLCdc8e448e-ac4e-4efc-8851-c368e31b9d692026-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
MetronidazoleMETRONIDAZOLEFougera Pharmaceuticals, LLC43ed872b-63ac-4a22-9c9e-cc0e05bcc41e2026-01-28Adverse reactionsExact identifier
unii: 140QMO216E
MetronidazoleMETRONIDAZOLEFougera Pharmaceuticals, LLC5368755a-dd37-4e34-843f-ece6bac8ef6a2026-01-28Adverse reactionsExact identifier
unii: 140QMO216E
Firming antibacterialFIRMING ANTIBACTERIALJiangxi He-Oumei Health Industry Co., Ltd.4923cdbf-a3a3-02f4-e063-6394a90ab8892026-01-24WarningsExact identifier
unii: 140QMO216E
MetronidazoleMETRONIDAZOLEREMEDYREPACK INC.1a28dce0-07af-401a-a6ac-1c2ee559c6682026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
PYLERABISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE, AND TETRACYCLINE HYDROCHLORIDEH2-Pharma, LLCc50626a2-5969-490b-a88a-a4ee45e796152026-01-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
metronidazoleMETRONIDAZOLEPreferred Pharmaceuticals Inc.ab695a3e-1721-491a-97a2-c3f617a8d9fc2026-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
MetronidazoleMETRONIDAZOLEGLENMARK PHARMACEUTICALS INC., USA6736c100-a7fe-44ea-8579-5537537ff9b82026-01-09Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
METRONIDAZOLEMETRONIDAZOLEDirect_Rx90a5acb3-f8cc-1e82-e053-2995a90a4e972026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
MetronidazoleMETRONIDAZOLEAmerican Health Packagingc90da73c-e48e-411a-bd75-0b107f1141cc2026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
MetronidazoleMETRONIDAZOLESolaris Pharma Corporation94a83daa-6e34-419d-849a-6f18d3b8c5862026-01-07Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
metronidazoleMETRONIDAZOLENorthwind Health Company, LLC06bd4afb-4a45-294c-e063-6394a90a7ab12026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
MetronidazoleMETRONIDAZOLENorthwind Health Company, LLCf2f55405-7f21-3ccc-e053-2a95a90a195a2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
MetronidazoleMETRONIDAZOLENorthwind Health Company, LLCf7e5dacd-0bc4-4ac4-e053-6394a90a457a2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
MetronidazoleMETRONIDAZOLEProficient Rx LPa56c2842-8ad4-4396-8eb6-cbcd1629fcb12026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 140QMO216E

Reported adverse events (FAERS/openFDA)#

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