FDA.reportPublic FDA data

NDC 68071-2409-01 - 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
68071-2409
Requested NDC
68071-2409-01
Package NDCs from labels
68071-2409-4, 68071-2409-3, 68071-2409-8, 68071-2409-1, 68071-2409-7, 68071-2409-2, 68071-2409-9, 68071-2409-5, 68071-2409-01
Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2024-02-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Metronidazole Tablets, USP Rx onlyNuCare Pharmaceuticals,Inc.2024-02-09HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
68071-2409-12024-02-09Metronidazole Tablets, USP Rx only
68071-2409-22024-02-09Metronidazole Tablets, USP Rx only
68071-2409-32024-02-09Metronidazole Tablets, USP Rx only
68071-2409-42024-02-09Metronidazole Tablets, USP Rx only
68071-2409-52024-02-09Metronidazole Tablets, USP Rx only
68071-2409-72024-02-09Metronidazole Tablets, USP Rx only
68071-2409-82024-02-09Metronidazole Tablets, USP Rx only
68071-2409-92024-02-09Metronidazole Tablets, USP Rx only
68071-2409-12023-01-30Metronidazole Tablets, USP Rx only
68071-2409-22023-01-30Metronidazole Tablets, USP Rx only
68071-2409-32023-01-30Metronidazole Tablets, USP Rx only
68071-2409-42023-01-30Metronidazole Tablets, USP Rx only
68071-2409-52023-01-30Metronidazole Tablets, USP Rx only
68071-2409-72023-01-30Metronidazole Tablets, USP Rx only
68071-2409-82023-01-30Metronidazole Tablets, USP Rx only
68071-2409-92023-01-30Metronidazole Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2409-1metronidazole4 in 1 BOTTLETABLET42
68071-2409-2metronidazole21 in 1 BOTTLETABLET212
68071-2409-3metronidazole30 in 1 BOTTLETABLET302
68071-2409-4metronidazole14 in 1 BOTTLETABLET142
68071-2409-5metronidazole40 in 1 BOTTLETABLET402
68071-2409-7metronidazole20 in 1 BOTTLETABLET202
68071-2409-8metronidazole28 in 1 BOTTLETABLET282
68071-2409-9metronidazole90 in 1 BOTTLETABLET902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2409METRONIDAZOLE TABLET [NUCARE PHARMACEUTICALS,INC.]2Current NDC, Legacy NDC, 8 package rows20240210_c2dbfec8-da5b-cd2b-e053-2a95a90ad17c.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 145 · 2,899 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350The Fresh Test, LLCcb8e182f-c23f-4f8d-9c09-24e19b2e914e2026-08-05WarningsExact identifier
unii: G2M7P15E5P
MetronidazoleMETRONIDAZOLEREMEDYREPACK INC.5cc3fd98-d579-432e-a4b5-b6d5586991a62026-08-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311681
unii: 140QMO216E
ROROBELL WAWA Whitening ToothSILICA, HYDROGEN PEROXIDE, TOCOPHERYL ACETATEROROBELL58336a0d-49dd-ef13-e063-6394a90a38c12026-08-04WarningsExact identifier
unii: ETJ7Z6XBU4
MetronidazoleMETRONIDAZOLEREMEDYREPACK INC.dc28753c-95ec-4b41-ad77-c4a66698d9db2026-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311681
unii: 140QMO216E
Silicea 6XSILICON DIOXIDEHyland's Inc.db4be3c1-aa7e-24a2-e053-2a95a90a0c662026-08-04WarningsExact identifier
unii: ETJ7Z6XBU4
Luxe Gloss Hydrating Lip Gloss SPF 35-NAKED HONEYOCTOCRYLENE 8%, OCTISALATE 5%, TITANIUM DIOXIDE 6%, ZINC OXIDE 8%Lale Cosmetics LLC581fb0cd-c55d-d562-e063-6394a90a7f112026-08-03WarningsExact identifier
unii: 15FIX9V2JP
metronidazoleMETRONIDAZOLEREMEDYREPACK INC.b49a8ad0-2cf9-4386-8bf5-1b1df87b00222026-08-03Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA206560
rxcui: 314106
unii: 140QMO216E
EltaMD UV ActiveZINC OXIDE AND TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Inc39d16479-d491-4c19-aa11-674461687c7b2026-08-03WarningsExact identifier
unii: 15FIX9V2JP
Continuous Correction CreamTITANIUM DIOXIDEBaxter of California, LLC1cbcc648-f2e1-af60-e063-6294a90ad4bb2026-07-31WarningsExact identifier
unii: 15FIX9V2JP
Cover CremeTITANIUM DIOXIDEBaxter of California31f5e8c4-523f-4596-e063-6294a90a6a122026-07-31WarningsExact identifier
unii: 15FIX9V2JP
SmogstatECHINACEA (ANGUSTIFOLIA), HYPERICUM PERFORATUM, HYDRASTIS CANADENSIS, SYMPHYTUM OFFICINALE, ARSENICUM ALBUM, CARBO VEGETABILIS, CAUSTICUM, KALI CARBONICUM, NATRUM SULPHURICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEAEnergique, Inc.59f63e2b-24fa-43a0-8334-02e6729c6ac12026-07-31WarningsExact identifier
unii: ETJ7Z6XBU4
Muscle IcePHYTOLACCA DECANDRA, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, SYMPHYTUM OFFICINALE, MAGNESIA PHOSPHORICA, SILICEA, MENTHOL (CRYSTALS)Peaceful Mountain, Inc.03b6e2a9-f335-4ae2-9011-80bd019afb722026-07-30WarningsExact identifier
unii: ETJ7Z6XBU4
BioplasmaSILICON DIOXIDE,POTASSIUM CHLORIDE,SODIUM SULFATE,FERROSOFERRIC PHOSPHATE,MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE,SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE,TRIBASIC CALCIUM PHOSPHATE,POTASSIUM PHOSPHATE, DIBASIC,POTASSIUM SULFATE,SODIUM CHLORIDE,CALCIUM SULFATE ANHYDROUS,CALCIUM FLUORIDEHyland's Inc.dd0a7ed2-d112-4b96-e053-2995a90ac6b62026-07-30WarningsExact identifier
unii: ETJ7Z6XBU4
metronidazoleMETRONIDAZOLEREMEDYREPACK INC.d5784eeb-6b99-4e8a-847b-b0d1090ed48a2026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA206560
rxcui: 311681
unii: 140QMO216E
Polyethylene Glycol 3350INSTALAX POLYETHYLENE GLYCOL 3350Sun Pharmaceutical Industries, Inc.40bd1be7-de67-8dff-e063-6294a90aca952026-07-24WarningsExact identifier
unii: G2M7P15E5P
ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 110-COCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEBEL STAR S.A.575fb2c3-e332-8a3b-e063-6394a90a9fd92026-07-24WarningsExact identifier
unii: 15FIX9V2JP
PEG 3350 and ElectrolytesPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDEA-S Medication Solutions19daf830-7270-4661-81b1-ded38f867f282026-07-24Warnings, Adverse reactionsExact identifier
unii: G2M7P15E5P
True Coast SPF 50 Mineral SunscreenZINC OXIDE 18%, TITANIUM DIOXIDE 6%Foshan Sugar Max Cosmetics CO.,Ltd5379466d-8d14-5fc2-e063-6394a90abd7e2026-07-22WarningsExact identifier
unii: 15FIX9V2JP
MetronidazoleMETRONIDAZOLEREMEDYREPACK INC.2f7d84d4-1085-4243-be88-442eecb852052026-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311681
unii: 140QMO216E
VagizoleMETRONIDAZOLEiNutrition LLCfd5e884b-cf07-493b-bb93-039bbb0c47842026-07-22Warnings, Adverse reactionsExact identifier
unii: 140QMO216E

Reported adverse events (FAERS/openFDA)#

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