FDA.reportPublic FDA data

NDC 68083-373-01 - Metronidazole

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
68083-373
Requested NDC
68083-373-01
Package NDCs from labels
68083-373-01, 68083-373-04
Manufacturer
Gland Pharma Limited
Effective date
2026-05-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Metronidazole - Gland Pharma LimitedGland Pharma Limited2026-05-15Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68083-373-01Metronidazole100 mL in 1 BAGINJECTION, SOLUTION10011
68083-373-01Metronidazole1 in 1 POUCHINJECTION, SOLUTION111
68083-373-04Metronidazole4 in 1 CARTONINJECTION, SOLUTION411

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68083-373METRONIDAZOLE INJECTION, SOLUTION [GLAND PHARMA LIMITED]9Current NDC, Legacy NDC, 3 package rows20240731_74cf111a-9b83-4f93-b0e8-bc252d471d43.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 31 of 64 · 1,271 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eye WashWATERCMC Group Inc.6158a1f5-a6bc-4a3e-9d1d-0a310d9dc5612025-04-02WarningsExact identifier
unii: 059QF0KO0R
metronidazoleMETRONIDAZOLEAMICI PHARMA INC9f1fec88-097f-42b9-a36f-214648d7eebb2025-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
Kidneyforce-HPARNICA MONTANA, AURUM METALLICUM, CACTUS GRANDIFLORUS, CALCAREA CARBONICA, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, SOLIDAGO VIRGAUREABioActive Nutritional, Inc.0c0f0c0c-10c2-47eb-aad6-bbffb6e167992025-04-02WarningsExact identifier
unii: 451W47IQ8X
metronidazoleMETRONIDAZOLEAMICI PHARMA INC4920fcf7-5ceb-46e9-82e0-dc508900bb912025-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
Sodium ChlorideSODIUM CHLORIDE TABLETBelleview Bioscience LLC31195e8f-d4de-9e37-e063-6294a90a41562025-03-24WarningsExact identifier
unii: 451W47IQ8X
Pituitary LiquescenceCAULOPHYLLUM THALICTROIDES, HYPOPHYSIS SUIS, HYPOTHALAMUS SUIS, PINEAL GLAND (SUIS), CIMICIFUGA RACEMOSA, NATRUM MURIATICUM, CINCHONA OFFICINALIS, ADRENOCORTICOTROPHINNutritional Specialties, Inc.292ca967-abe8-4ae1-b2fe-942531a1e14a2025-03-20WarningsExact identifier
unii: 451W47IQ8X
Anxiety HPACONITUM NAPELLUS, ARGENTUM NITRICUM, ARSENICUM ALBUM, CALCAREA CARBONICA, IGNATIA AMARA, KALI CARBONICUM, LACHESIS MUTUS, NATRUM MURIATICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), STAPHYSAGRIA, STRAMONIUMEnergique, Inc.191393fa-5f36-43c0-a183-09258eef9bda2025-03-20WarningsExact identifier
unii: 451W47IQ8X
HYDRA NEBSODIUM CHLORIDEVenture Healthcare Ltd30b184bf-2451-d96b-e063-6294a90a43c72025-03-19WarningsExact identifier
unii: 451W47IQ8X
HYDRA NEBSODIUM CHLORIDELaboratoire Unither30b244c0-84bb-a0a0-e063-6394a90a9dee2025-03-19WarningsExact identifier
unii: 451W47IQ8X
MetronidazoleMETRONIDAZOLEAlembic Pharmaceuticals Limitede43b880b-ce69-4f56-9c1c-9c7ca23bba842025-03-18Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
Psora MiasmEGGSHELL MEMBRANE, WHEY PROTEIN, CALCAREA CARBONICA, LYCOPODIUM CLAVATUM, SULPHUR, ARSENICUM ALBUM, CROTON TIGLIUM, GRAPHITES, HYDROCOTYLE ASIATICA, NATRUM MURIATICUMEnergique, Inc.6a12aa49-35fc-41f4-bec8-6f9a20a97caa2025-03-13WarningsExact identifier
unii: 451W47IQ8X
AeroWash EyewashEYEWASH SOLUTIONAero Healthcare US LLCa477de08-4301-0ee5-e053-2995a90af79d2025-02-26WarningsExact identifier
unii: 059QF0KO0R
MetronidazoleMETRONIDAZOLEAlembic Pharmaceuticals Inc.f9b4c86c-932b-4b43-ab1a-6d9e079580442025-02-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
Adrenal LiquescenceGLYCYRRHIZA GLABRA, ROSA CANINA, ARALIA QUINQUEFOLIA, GLANDULA SUPRARENALIS (BOVINE), ADRENALINUM, CINCHONA OFFICINALIS, NATRUM MURIATICUM, ZINCUM METALLICUM, ADRENOCORTICOTROPHINNutritional Specialties, Inc.5254181b-188e-4ef2-b91e-15e87e31de702025-02-26WarningsExact identifier
unii: 451W47IQ8X
Advanced Eye Relief Eye WashWATER SOLUTIONBausch & Lomb Incorporated9caccce1-4530-441d-bf76-244edeb9dedc2025-02-17WarningsExact identifier
unii: 059QF0KO0R
Natrum Phosphoricum 6XNATRUM PHOSPHORICUMSEVENE USAff0d77ad-3e04-25ea-e053-6294a90a0def2025-02-11WarningsExact identifier
unii: 70WT22SF4B
NATRUM MURIATICUM 200ckNATRUM MURIATICUMSEVENE USAcf892234-de72-37e1-e053-2995a90a1c392025-02-11WarningsExact identifier
unii: 451W47IQ8X
Natrum Muriaticum 6XSODIUM CHLORIDESEVENE USAff0d279e-210a-6f8a-e053-6294a90a11dc2025-02-11WarningsExact identifier
unii: 451W47IQ8X
Stage Fright-FearACONITUM NAP., ANACARDIUM, ARG. NIT., ARSENICUM ALB., CYPRIPEDIUM, GELSEMIUM, IGNATIA, KALI CARB., LYCOPODIUM, NAT.MUR., PHOS., SAMBUCUS NIG., SEPIA, STAPHYSAG., STRAMONIUM, TARENTULA HISPANA, THERIDION, PASSIFLORA, VALERIANANewton Laboratories, Inc.2df84360-dfff-9851-e063-6394a90ad7902025-02-11WarningsExact identifier
unii: 451W47IQ8X
12 CELL SALTS COMPLEXCALCAREA FLUORICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, FERRUM PHOSPHORICUM, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, SILICEASEVENE USAff0f69cd-97a2-7183-e053-6394a90ad0392025-02-10WarningsExact identifier
unii: 451W47IQ8X
unii: 70WT22SF4B

Reported adverse events (FAERS/openFDA)#

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