FDA.reportPublic FDA data

NDC 42292-001-01 - 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
42292-001
Requested NDC
42292-001-01
Package NDCs from labels
42292-001-01, 42292-001-20
Manufacturer
Mylan Institutional Inc.
Effective date
2019-12-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
METRONIDAZOLE TABLETS, USP 250 mg and 500 mg Rx OnlyMylan Institutional Inc.2019-12-30HUMAN PRESCRIPTION DRUG LABEL
Metronidazole - Cardinal HealthCardinal Health2018-12-17HUMAN PRESCRIPTION DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42292-001-01EA - Each42292-001fcaed41b-4002-4a1d-b77a-e58944386af512015-07-20
42292-001-17EA - Each42292-0016d55dcba-38dc-4f12-8ca3-67e8002a09c312015-07-20
42292-001-19EA - Each42292-001e362e834-9025-4101-ae4f-9a7a8863bdc812015-07-20
42292-001-20EA - Each42292-001f66f3f8e-c71e-452a-809a-af6a1434af6d12015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METRONIDAZOLEACTIVE INGREDIENT140QMO216EMETRONIDAZOLE TABLET [MYLAN INSTITUTIONAL INC.]1
METRONIDAZOLEACTIVE MOIETY140QMO216EMETRONIDAZOLE TABLET [MYLAN INSTITUTIONAL INC.]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKMETRONIDAZOLE TABLET [MYLAN INSTITUTIONAL INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETRONIDAZOLE TABLET [MYLAN INSTITUTIONAL INC.]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PMETRONIDAZOLE TABLET [MYLAN INSTITUTIONAL INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METRONIDAZOLE TABLET [MYLAN INSTITUTIONAL INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2METRONIDAZOLE TABLET [MYLAN INSTITUTIONAL INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APMETRONIDAZOLE TABLET [MYLAN INSTITUTIONAL INC.]1

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 8 of 37 · 732 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
FuligoCIMICIFUGA, DROSERA, FORMICA RUFA, FULIGO, INULA HEL., KALI MUR, LAPIS ALBUS, SILICEABM Private Limited3b27225f-4587-d915-e063-6294a90a72252026-02-12WarningsExact identifier
unii: ETJ7Z6XBU4
Mold, Yeast and DustADRENALINUM, ARSENICUM IODATUM, ASPERGILLUS FLAVUS, ASPERGILLUS FUMIGATUS, ASPERGILLUS GLAUCUS, ASPERGILLUS NIDULANS, ASPERGILLUS NIGER, CANDIDA ALBICANS, DERMATOPHAGOIDES FARINAE, HISTAMINUM HYDROCHLORICUM, LYCOPODIUM CLAVATUM, MUCOR PLUMBEUS, NATRUM SULPHURICUM, PENICILLIUM DIGITATUM, PENICILLIUM ROQUEFORTII, SACCHAROMYCES CEREVISIAE, SILICEANaturalCare32afa0f0-bca5-4246-bc2e-decd757fcf9d2026-02-09WarningsExact identifier
unii: ETJ7Z6XBU4
metronidazoleMETRONIDAZOLESportpharm LLCdc8e448e-ac4e-4efc-8851-c368e31b9d692026-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
DPT-TOXDROSERA, ECHINACEA, HYPERICUM, KALI MUR, MEZEREUM, SILICEA, THUJANutrition Center Inc dba Nutri-West dba Micro-West5e39f4e6-939f-4b71-9cc5-6d4b8711ea322026-02-04WarningsExact identifier
unii: ETJ7Z6XBU4
Meteoric Iron PrunusMETEORIC IRON PRUNUSUriel Pharmacy Inc.e9020757-2393-4a22-9665-25da0a0993d02026-02-03WarningsExact identifier
unii: ETJ7Z6XBU4
Mold, Yeast and DustACREMONIUM STRICTUM, ADRENALINUM, ALLIUM CEPA, ALTERNARIA ALTERNATA, ARSENICUM IODATUM, ASPERGILLUS FUMIGATUS, ASPERGILLUS NIGER, AUREOBASIDIUM PULLULANS, CANDIDA ALBICANS, CLADOSPORIUM HERBARUM, COCKROACH, DERMATOPHAGOIDES FARINAE, EPICOCCUM PURPURASCENS, FUSARIUM SOLANI, HISTAMINUM HYDROCHLORICUM, LYCOPODIUM CLAVATUM, MUCOR CIRCINELLOIDES, NATRUM SULPHURICUM, RHIZOPUS STOLONIFER, SACCHAROMYCES CEREVISIAE, SILICEANaturalCaree0f53f47-acd9-43e2-a7a2-2a500bc9dc1b2026-02-03WarningsExact identifier
unii: ETJ7Z6XBU4
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
BioMicroneedle PDRN CreamSILICON DIOXIDEGuangzhou Shengyanghui Industrial Trading Co., Ltd48e2edae-94ea-c42e-e063-6394a90a907b2026-01-21WarningsExact identifier
unii: ETJ7Z6XBU4
Inflammation IECHINACEA (ANGUSTIFOLIA), NASTURTIUM AQUATICUM, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, APIS MELLIFICA, BELLADONNA, FERRUM PHOSPHORICUM, NITRICUM ACIDUM, OLEANDER, SILICEABioActive Nutritional, Inc.3cb12181-ae7e-45c7-a1b1-e1952f36f8c32026-01-21WarningsExact identifier
unii: ETJ7Z6XBU4
MetronidazoleMETRONIDAZOLEREMEDYREPACK INC.1a28dce0-07af-401a-a6ac-1c2ee559c6682026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
DENTI BUONGIORNO PLAQUE CARE LEMON MINT TOOTHSILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATE, TETRASODIUM PYROPHOSPHATEATOSAFE CO., Ltd487c5036-0eb0-ada9-e063-6394a90aa02e2026-01-16WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO PLAQUE CARE LEMON MINT TOOTHSILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATE, TETRASODIUM PYROPHOSPHATEDONG IL PHARMS CO.,LTD487cd5b9-28f3-392d-e063-6394a90a9ba12026-01-16WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO GUM CARE COOL MINT TOOTHSILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATEATOSAFE CO., Ltd487cf27a-d761-6353-e063-6394a90af0292026-01-16WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO FRESH BREATH HERB MINT TOOTHSILICA, SODIUM MONOFLUOROPHOSPHATEATOSAFE CO., Ltd487d52d1-8853-bc90-e063-6394a90ab91d2026-01-16WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO GUM CARE COOL MINT TOOTHSILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATEDONG IL PHARMS CO.,LTD487d689d-ebdd-43c3-e063-6294a90af0e22026-01-16WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO FRESH BREATH HERB MINT TOOTHSILICA, SODIUM MONOFLUOROPHOSPHATEDONG IL PHARMS CO.,LTD487da363-1d01-8cdc-e063-6294a90ac24d2026-01-16WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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