FDA.reportPublic FDA data

NDC 68071-3402-08 - AMOXICILLIN AND CLAVULANATE POTASSIUM

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
68071-3402
Requested NDC
68071-3402-08
Package NDCs from labels
68071-3402-3, 68071-3402-4, 68071-3402-8, 68071-3402-1, 68071-3402-6, 68071-3402-08
Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2026-08-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
AMOXICILLIN AND CLAVULANATE POTASSIUM - NuCare Pharmaceuticals,Inc.NuCare Pharmaceuticals,Inc.2026-08-12HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3402-1AMOXICILLIN AND CLAVULANATE POTASSIUM10 in 1 BOTTLETABLET, FILM COATED104
68071-3402-3AMOXICILLIN AND CLAVULANATE POTASSIUM30 in 1 BOTTLETABLET, FILM COATED304
68071-3402-4AMOXICILLIN AND CLAVULANATE POTASSIUM14 in 1 BOTTLETABLET, FILM COATED144
68071-3402-8AMOXICILLIN AND CLAVULANATE POTASSIUM28 in 1 BOTTLETABLET, FILM COATED284

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3402AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]4Current NDC, 4 package rows20240119_fbd40fcd-bf5b-e91e-e053-6394a90a609c.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 1 of 157 · 3,121 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lymph Tonic IIECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANABioActive Nutritional, Inc.0e3265b0-b210-4a4c-80d2-8a9712981d4e2026-09-17WarningsExact identifier
unii: ETJ7Z6XBU4
AMOXICILLINAMOXICILLINREMEDYREPACK INC.4adc198e-39d8-4b3e-bfa4-278aaf4064ae2026-09-09Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
AMOXICILLINAMOXICILLINChartwell RX, LLCb07b5ac4-253e-4c83-91c3-3fdc46e91a0f2026-09-04Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Psoriasis ControlCENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature2db33771-0bb9-49f8-84fa-dddc28e4ba262026-09-04WarningsExact identifier
unii: ETJ7Z6XBU4
AmoxicillinAMOXICILLINREMEDYREPACK INC.b6ea2f81-aee6-4c88-b681-50eb28e80a862026-09-03Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Dr.Harry EYES PROTECTIONPOLYETHYLENE GLYCOL 400 1% EYES PROTECTIONWenzhou Yuyuan Pharmaceutical Co., Ltd.5a9fe033-89d3-da62-e063-6294a90a45032026-09-03WarningsExact identifier
unii: B697894SGQ
AmoxicillinAMOXICILLINRedpharm Drug5a79669f-52f7-e8ea-e063-6394a90a93b82026-09-02Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINREMEDYREPACK INC.f37eb415-77b2-41b0-8d20-64e821e4b05d2026-09-02Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AMOXICILLINAMOXICILLINRedpharm Drug5a660370-9a81-33f9-e063-6394a90a6c622026-09-01Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMREMEDYREPACK INC.a26f2ceb-bb9b-4813-9691-6343381868602026-08-31Warnings, Adverse reactionsExact identifier
application number: ANDA204755
rxcui: 562508
unii: Q42OMW3AT8
unii: 804826J2HU
BMNP SiliceaSILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro5a58454f-aed6-24ba-e063-6294a90a47fb2026-08-31WarningsExact identifier
unii: ETJ7Z6XBU4
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMSportpharm LLC69e45bc0-de57-4603-a9eb-335988dfe0bf2026-08-29Warnings, Adverse reactionsExact identifier
rxcui: 562508
unii: Q42OMW3AT8
unii: 804826J2HU
AmoxicillinAMOXICILLINSportpharm LLCc4d4aeca-f63c-4548-a9b7-7f627e8fd45c2026-08-29Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMREMEDYREPACK INC.e5b0770d-1301-498e-a4ed-41874d7bf2252026-08-27Warnings, Adverse reactionsExact identifier
rxcui: 562508
unii: Q42OMW3AT8
unii: 804826J2HU
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMNuCare Pharmaceuticals,Inc.7526a33a-18d6-36ca-e053-2a91aa0ab9f92026-08-26Warnings, Adverse reactionsExact identifier
application number: ANDA204755
rxcui: 562508
unii: Q42OMW3AT8
unii: 804826J2HU
Argentum QuartzARGENTUM QUARTZUriel Pharmacy Inc.765c8c8f-0727-45da-a77e-c3907a3d07932026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
Endometrium ArgentumENDOMETRIUM ARGENTUMUriel Pharmacy Incd2d1428a-c8b5-9529-e053-2995a90a23432026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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