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 35 of 143 · 2,846 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SHISEIDO SPORTS BB LIGHTOCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION260a3eab-8fe6-4259-8dcc-3706ca1f68812026-01-05WarningsExact identifier
unii: 15FIX9V2JP
SHISEIDO ULTIMATE SUN PROTECTOROCTISALATE, TITANIUM DIOXIDE, OCTOCRYLENE, AND ZINC OXIDESHISEIDO AMERICAS CORPORATIONc656792a-e1ed-478d-b501-9bdc92d16eca2026-01-05WarningsExact identifier
unii: 15FIX9V2JP
SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 110 ALABASTEROCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION0a214b6b-69a7-4cb9-9095-6fcf2b6945de2026-01-05WarningsExact identifier
unii: 15FIX9V2JP
SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 430 CEDAROCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONfb6ac681-ff74-4420-a4f6-843d5f2b6d6b2026-01-05WarningsExact identifier
unii: 15FIX9V2JP
Hawaiian Blend Essential Zinc SPF 50ZINC OXIDE, TITANIUM DIOXIDEThe Islander Group47aa8605-e536-b998-e063-6394a90ad9f02026-01-05WarningsExact identifier
unii: 15FIX9V2JP
SHISEIDO WHITE LUCENT ONMAKEUP SPOT CORRECTING SERUM NATURAL LIGHTOCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONbf736c5b-fc33-4cd5-8d18-03929f739d762026-01-05WarningsExact identifier
unii: 15FIX9V2JP
CLE DE PEAU BEAUTE RADIANT CORRECTOR FOR EYES IVORYOCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONc4028089-677f-4d51-9c8b-3892ff1649e02026-01-05WarningsExact identifier
unii: 15FIX9V2JP
SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION 110OCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION8a0da327-a805-4ef9-b69a-14bf7278a81a2026-01-05WarningsExact identifier
unii: 15FIX9V2JP
CLE DE PEAU BEAUTE CORRECTING VEIL nENSULIZOLE, OCTINOXATE, AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONfd9b42e4-6f9d-45a9-bee3-ac1bc4b352522026-01-05WarningsExact identifier
unii: 15FIX9V2JP
SHISEIDO THE MAKEUP FOUNDATION I20TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION3c024fe9-2983-4857-a55a-13406158e3a92026-01-05WarningsExact identifier
unii: 15FIX9V2JP
cle de peau BEAUTE RADIANT FLUID FOUNDATION BF10TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONb2b55a7a-1f68-429d-ba70-5bb6c7e0d8d32026-01-05WarningsExact identifier
unii: 15FIX9V2JP
TRICK AND TREAT CC2 - Active Moisturizing Color Correcting Broad-Spectrum SPF 46 PlusTITANIUM DIOXIDEHEY HONEY INC.21187805-fae9-476c-81b0-27ffeb0b99112026-01-05WarningsExact identifier
unii: 15FIX9V2JP
ParathyroparSYMPHYTUM OFFICINALE, BARYTA CARBONICA, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, HEKLA LAVA, MANGANUM METALLICUM, PARATHYROID GLAND (BOVINE), RHUS TOX, SILICEAEnergique, Inc.6b098910-2f36-4757-a463-e01105340c432026-01-05WarningsExact identifier
unii: ETJ7Z6XBU4
VACC HCANTIMONIUM TARTARICUM, ARSENICUM ALBUM, BRYONIA (ALBA), ECHINACEA (ANGUSTIFOLIA), GELSEMIUM SEMPERVIRENS, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, HYOSCYAMUS NIGER, INFLUENZINUM, LEDUM PALUSTRE, MERCURIUS SOLUBILIS, MEZEREUM, NICOTINAMIDUM, HUMAN CORONAVIRUS (RNA), SENEGA OFFICINALIS, SILICEA, SPIGELIA ANTHELMIA, SULPHUR, THUJA OCCIDENTALIS, ZINCUM METALLICUMDeseret Biologicals, Inc.16d782b2-1bef-45e5-8a1d-721b1ffe56312026-01-05WarningsExact identifier
unii: ETJ7Z6XBU4
Bellas Friends Roll-on SunscreenTITANIUM DIOXIDE, ZINC OXIDEPANERGYTEK USA INC478d46ce-14e8-2231-e063-6394a90a3e272026-01-04WarningsExact identifier
unii: 15FIX9V2JP
metronidazoleMETRONIDAZOLENorthwind Health Company, LLC06bd4afb-4a45-294c-e063-6394a90a7ab12026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA206560
rxcui: 311681
unii: 140QMO216E
MetronidazoleMETRONIDAZOLENorthwind Health Company, LLCf2f55405-7f21-3ccc-e053-2a95a90a195a2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311681
unii: 140QMO216E
MetronidazoleMETRONIDAZOLENorthwind Health Company, LLCf7e5dacd-0bc4-4ac4-e053-6394a90a457a2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 314106
unii: 140QMO216E
MetronidazoleMETRONIDAZOLEProficient Rx LPa56c2842-8ad4-4396-8eb6-cbcd1629fcb12026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311681
unii: 140QMO216E
Youth Glow Vitamin C CC Cream Sunscreen SPF 50 - FairOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC47428cd4-fbad-ba7a-e063-6394a90a1c5c2025-12-31WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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