FDA.reportPublic FDA data

NDC 42571-162-43 - 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
42571-162
Requested NDC
42571-162-43
Package NDCs from labels
42571-162-42, 42571-162-01, 42571-162-43, 42571-162-44
Manufacturer
REMEDYREPACK INC.
Effective date
2026-08-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
AMOXICILLIN AND CLAVULANATE POTASSIUM - REMEDYREPACK INC.REMEDYREPACK INC.2026-08-31HUMAN PRESCRIPTION DRUG LABEL
AMOXICILLIN AND CLAVULANATE POTASSIUM - NuCare Pharmaceuticals,Inc.NuCare Pharmaceuticals,Inc.2026-08-26HUMAN PRESCRIPTION DRUG LABEL
AMOXICILLIN AND CLAVULANATE POTASSIUM - NuCare Pharmaceuticals,Inc.NuCare Pharmaceuticals,Inc.2026-08-12HUMAN PRESCRIPTION DRUG LABEL
AMOXICILLIN AND CLAVULANATE POTASSIUM - REMEDYREPACK INC.REMEDYREPACK INC.2026-06-19HUMAN PRESCRIPTION DRUG LABEL
AMOXICILLIN AND CLAVULANATE POTASSIUM - Northwind Health Company, LLCNorthwind Health Company, LLC2026-06-18HUMAN PRESCRIPTION DRUG LABEL
AMOXICILLIN AND CLAVULANATE POTASSIUM - Micro Labs LimitedMicro Labs Limited2026-06-09HUMAN PRESCRIPTION DRUG LABEL
AMOXICILLIN AND CLAVULANATE POTASSIUM - Proficient Rx LPProficient Rx LP2026-06-01HUMAN PRESCRIPTION DRUG LABEL
AMOXICILLIN AND CLAVULANATE POTASSIUM - Preferred Pharmaceuticals Inc.Preferred Pharmaceuticals Inc.2026-01-13HUMAN PRESCRIPTION DRUG LABEL
AMOXICILLIN AND CLAVULANATE POTASSIUM - NuCare Pharmaceuticals,Inc.NuCare Pharmaceuticals,Inc.2025-11-20HUMAN PRESCRIPTION DRUG LABEL
AMOXICILLIN AND CLAVULANATE POTASSIUM - Bryant Ranch PrepackBryant Ranch Prepack2025-10-23HUMAN PRESCRIPTION DRUG LABEL
Amoxicillin and Clavulanate Potassium - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2025-02-02HUMAN PRESCRIPTION DRUG LABEL
AMOXICILLIN AND CLAVULANATE POTASSIUM - Bryant Ranch PrepackBryant Ranch Prepack2024-12-16HUMAN PRESCRIPTION DRUG LABEL
AMOXICILLIN AND CLAVULANATE POTASSIUM - RedPharm Drug, Inc.RedPharm Drug, Inc.2024-07-24HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
42571-162-012020-07-29These highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS. AMOXICILLIN and CLAVULANATE POTASSIUM tablets, for oral use Initial U.S. Approval: 1984
42571-162-012020-07-29These highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS. AMOXICILLIN and CLAVULANATE POTASSIUM tablets, for oral use Initial U.S. Approval: 1984
42571-162-422020-07-29These highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS. AMOXICILLIN and CLAVULANATE POTASSIUM tablets, for oral use Initial U.S. Approval: 1984
42571-162-422020-07-29These highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS. AMOXICILLIN and CLAVULANATE POTASSIUM tablets, for oral use Initial U.S. Approval: 1984
42571-162-442020-07-29These highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS. AMOXICILLIN and CLAVULANATE POTASSIUM tablets, for oral use Initial U.S. Approval: 1984
42571-162-442020-07-29These highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS. AMOXICILLIN and CLAVULANATE POTASSIUM tablets, for oral use Initial U.S. Approval: 1984
42571-162-012020-07-22These highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS. AMOXICILLIN and CLAVULANATE POTASSIUM tablets, for oral use Initial U.S. Approval: 1984
42571-162-012020-07-22These highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS. AMOXICILLIN and CLAVULANATE POTASSIUM tablets, for oral use Initial U.S. Approval: 1984
42571-162-422020-07-22These highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS. AMOXICILLIN and CLAVULANATE POTASSIUM tablets, for oral use Initial U.S. Approval: 1984
42571-162-422020-07-22These highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS. AMOXICILLIN and CLAVULANATE POTASSIUM tablets, for oral use Initial U.S. Approval: 1984
42571-162-442020-07-22These highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS. AMOXICILLIN and CLAVULANATE POTASSIUM tablets, for oral use Initial U.S. Approval: 1984
42571-162-442020-07-22These highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS. AMOXICILLIN and CLAVULANATE POTASSIUM tablets, for oral use Initial U.S. Approval: 1984

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42571-162-01AMOXICILLIN AND CLAVULANATE POTASSIUM100 in 1 BOTTLETABLET, FILM COATED10025
42571-162-42AMOXICILLIN AND CLAVULANATE POTASSIUM20 in 1 BOTTLETABLET, FILM COATED2025
42571-162-43AMOXICILLIN AND CLAVULANATE POTASSIUM4 in 1 BLISTER PACKTABLET, FILM COATED425
42571-162-44AMOXICILLIN AND CLAVULANATE POTASSIUM4 in 1 CARTONTABLET, FILM COATED425

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42571-162AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM) TABLET, FILM COATED [MICRO LABS LIMITED]24Current NDC, Legacy NDC, 4 package rows20240927_0c2d1fbc-f80c-4737-a15e-9cfa6bf99769.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42571-162-01EA - Each42571-1624b91eaac-e2d6-4c19-953c-feebeb52571812017-09-11
42571-162-42EA - Each42571-162fa7d7480-6d23-4e16-aafe-d050058d98fd12017-09-11

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 159 · 3,165 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
ndc (package): 70518-2263-4
ndc (package): 70518-2263-0
ndc (package): 70518-2263-2
ndc (package): 70518-2263-3
ndc (package): 70518-2263-1
ndc (package): 70518-2263-9
ndc (package): 70518-2263-6
ndc (package): 70518-2263-8
ndc (package): 70518-2263-7
ndc (package): 70518-2263-5
ndc (product): 70518-2263
rxcui: 562508
spl id: 5a584471-a6d1-38bb-e063-6394a90ab246
spl set id: a26f2ceb-bb9b-4813-9691-634338186860
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
ndc (package): 68071-4549-6
ndc (package): 68071-4549-4
ndc (package): 68071-4549-3
ndc (product): 68071-4549
rxcui: 562508
spl id: 59f56ba0-fe19-5521-e063-6294a90a4949
spl set id: 7526a33a-18d6-36ca-e053-2a91aa0ab9f9
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.