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 22 of 143 · 2,846 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alumier MD Clear Shield Broad Spectrum SPF 42 SunscreenTITANIUM DIOXIDE, ZINC OXIDEAlumier Labsa9c970c8-b6e3-b0a1-e053-2a95a90a89c72026-02-09WarningsExact identifier
unii: 15FIX9V2JP
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
Hampton Sun SPF 50 MineralZINC OXIDE 19.5% TITANIUM DIOXIDE 4.00%S&C Hampton Sun LLCd6c33436-042e-44e8-8b55-98be6e2468792026-02-06WarningsExact identifier
unii: 15FIX9V2JP
SHISEIDO WASO COLOR-SMART DAY MOISTURIZEROCTINOXATE, TITANIUM DIOXIDEShiseido Americas Corporationf291f077-1c72-48fc-bb19-c20bdeaaa5962026-02-06WarningsExact identifier
unii: 15FIX9V2JP
SHISEIDO WASO COLOR-SMART DAY MOISTURIZEROCTINOXATE, TITANIUM DIOXIDEShiseido Americas Corporation54f63dd8-e77f-42e4-a6d3-61ab7beecf502026-02-06WarningsExact identifier
unii: 15FIX9V2JP
SEYTU Body SunscreenTITANIUM DIOXIDE AND ZINC OXIDEOmnilife USA, Inc.c411e9a6-b2ea-446b-a886-b92c61736e6c2026-02-05WarningsExact identifier
unii: 15FIX9V2JP
SEYTU Facial SunscreenTITANIUM DIOXIDE AND ZINC OXIDEOmnilife USA, Inc.96fd37fb-c3ff-413f-b2c8-50754f320ecc2026-02-05WarningsExact identifier
unii: 15FIX9V2JP
metronidazoleMETRONIDAZOLESportpharm LLCdc8e448e-ac4e-4efc-8851-c368e31b9d692026-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA206560
rxcui: 311681
unii: 140QMO216E
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 BambooOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SASebfe03e7-614f-44b1-b1f1-78edc7e274cc2026-02-05WarningsExact identifier
unii: 15FIX9V2JP
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
SHISEIDO URBAN ENVIRONMENT oil-free MINERAL SUNSCREEN SPF 42TITANIUM DIOXIDE AND ZINC OXIDESHISEIDO AMERICAS CORPORATION86630e82-f249-4866-82dd-3e21feb266c42026-02-04WarningsExact identifier
unii: 15FIX9V2JP
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
Dr.Oracle AIR FIT DEFENSE SOOTHING SUNSCREENHOMOSALATE, OCTYL SALICYLATE, TITANIUM DIOXIDE, ZINC OXIDEOracle Cosmetic Co., Ltd.21424f78-f8d5-6a9b-e063-6294a90ab7dc2026-02-02WarningsExact identifier
unii: 15FIX9V2JP
Reef safe unscented SPF 50 mineral sunscreen 01TITANIUM DIOXIDE, ZINC OXIDECosmuses Cosmetics (Ningbo) Co., Ltd.49a77ad4-508c-9617-e063-6394a90a56232026-01-30WarningsExact identifier
unii: 15FIX9V2JP
JOSIE MARAN ARGAN SUN MILK MINERAL SUNSCREEN BROAD SPECTRUM SPF 33TITANIUM DIOXIDE AND ZINC OXIDECosmetic Solutions LLCd65ae1c9-dff5-4612-b8be-fa59bba03b812026-01-30WarningsExact identifier
unii: 15FIX9V2JP
MetronidazoleMETRONIDAZOLEFougera Pharmaceuticals, LLC43ed872b-63ac-4a22-9c9e-cc0e05bcc41e2026-01-28Adverse reactionsExact identifier
unii: 140QMO216E
SHISEIDO SPORTS BB DARKOCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONf4fc4b6a-9507-496e-9ecb-8400055ecf2d2026-01-28WarningsExact identifier
unii: 15FIX9V2JP
Hampton Sun SPF 30 MineralZINC OXIDE 7.20% TITANIUM DIOXIDE 4.00%S&C Hampton Sun LLCb8ee428e-07d3-4c6c-853c-cfbe3e4002d92026-01-28WarningsExact identifier
unii: 15FIX9V2JP
MetronidazoleMETRONIDAZOLEFougera Pharmaceuticals, LLC5368755a-dd37-4e34-843f-ece6bac8ef6a2026-01-28Adverse reactionsExact identifier
unii: 140QMO216E

Reported adverse events (FAERS/openFDA)#

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