NDC 85534-0071-01 - Amoxicillin

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
85534-0071
Requested NDC
85534-0071-01
Package NDCs from labels
85534-0071-0, 85534-0071-1, 85534-0071-2, 85534-0071-01
Manufacturer
HAWAII REPACK, INC.
Effective date
2026-07-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Amoxicillin - HAWAII REPACK, INC.HAWAII REPACK, INC.2026-07-03HUMAN PRESCRIPTION DRUG LABEL

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 54 of 56 · 1,102 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GUNA MATRIX DETOXSODIUM SULFATE - PODOPHYLLUM PELTATUM ROOT - SOLIDAGO VIRGAUREA FLOWERING TOP - APIS MELLIFERA - EQUISETUM HYEMALE - STRYCHNOS NUX VOMICA SEED - HAMAMELIS VIRGINIANA ROOT BARK STEM BARK - LYCOPODIUM CLAVATUM SPORE - GALIUM APARINE WHOLE - THUJA OCCIDENTALIS LEAFY TWIG - BERBERIS VULGARIS ROOT BARK - MYOSOTIS ARVENSIS - CHELIDONIUM MAJUS WHOLE - FUCUS VESICULOSUS -Guna spaa369b95b-4d57-f149-e053-2995a90a87e32020-10-23Warnings, Adverse reactionsExact identifier
unii: ETJ7Z6XBU4
SupremeABROTANUM, ANACARDIUM ORIENTALE, ARSENICUM ALBUM, BARYTA MURIATICA, HELLEBORUS NIGER, IGNATIA AMARA, LYCOPODIUM CLAVATUM, NICOTINAMIDUM, SECALE CORNUTUM, THYMUS (BOVINE), THYROIDINUM (BOVINE), CALCAREA CARBONICA, CALCAREA PHOSPHORICA, HYPOTHALAMUS SUIS, PITUITARUM POSTERIUM (BOVINE), SILICEABOUARI GROUP, LLC dba WEIGHT LOSS COMPANY, THE72c4679b-aa97-4888-9178-581d0f99c0b62020-09-11WarningsExact identifier
unii: ETJ7Z6XBU4
AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMAsclemed USA, Inc.bf29327f-4e43-4597-83d2-f64349bf9d9a2020-09-01Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINProficient Rx LPead1e453-af08-4a3b-8379-aa182dff514b2020-09-01Warnings, Adverse reactionsExact identifier
application number: ANDA065378
rxcui: 308189
unii: 804826J2HU
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.ee831456-5962-4d5e-ad0c-69ab858604532020-06-03Exact identifier
unii: XF417D3PSL
AmoxicillinAMOXICILLINProficient Rx LP7974a666-6d1d-446b-8ea5-f7145dc663582020-02-01Warnings, Adverse reactionsExact identifier
rxcui: 308194
unii: 804826J2HU
RenacidinCITRIC ACID, GLUCONOLACTONE AND MAGNESIUM CARBONATEUnited-Guardian, Inc.13a9bbba-db21-4cba-991c-5d8afaf2ed742019-12-17Warnings, Adverse reactionsExact identifier
unii: XF417D3PSL
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.e41adb4e-06fb-4141-ba55-50b043f3c9da2019-11-19Exact identifier
unii: XF417D3PSL
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.14445dfd-6041-40cd-a043-3f4da6bcb9c12019-11-18Exact identifier
unii: XF417D3PSL
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.2557199a-5f60-49d8-b093-1e07002112432019-11-18Exact identifier
unii: XF417D3PSL
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.794f724c-87f0-49c1-9b26-c9e4919783132019-11-18Exact identifier
unii: XF417D3PSL
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.5c7d3287-883a-459b-9214-074a583c8a592019-11-18Exact identifier
unii: XF417D3PSL
CPDA-1ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINEFenwal, Inc.448a1dc5-7a98-4b2f-82af-4b92de05cfc32019-11-18Exact identifier
unii: XF417D3PSL
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMProficient Rx LP4655e0ea-f7d5-4f7c-bf7b-266337bc05b82019-11-01Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
amoxicillin and clavulanate potassiumAMOXICILLIN AND CLAVULANATE POTASSIUMProficient Rx LP1f252ad3-373c-4a6d-96e7-53ba820d201b2019-11-01Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMProficient Rx LP01b30abb-db63-4257-9fe2-9107bb0bd69c2019-11-01Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINProficient Rx LP45a872b8-07b1-44fe-8b57-cc572d480e2e2019-10-01Warnings, Adverse reactionsExact identifier
rxcui: 308189
unii: 804826J2HU
Skin Klear Acne ReliefTRIBASIC CALCIUM PHOSPHATE, FUMARIA OFFICINALIS FLOWERING TOP, ARCTIUM LAPPA ROOT, SODIUM CHLORIDE, SAPONARIA OFFICINALIS ROOT, SILICON DIOXIDE, SOLIDAGO VIRGAUREA FLOWERING TOP, SULFUR, VIOLA TRICOLORHomeocare Laboratories65afbc20-611b-4bc4-a151-c633bec66a822018-12-31WarningsExact identifier
unii: ETJ7Z6XBU4
Sinus ReliefASAFETIDA, ECHINACEA ANGUSTIFOLIA, CALCIUM SULFIDE, POTASSIUM DICHROMATE, LUFFA OPERCULATA WHOLE, SILICON DIOXIDE, SINUSITISINUMHomeocare Laboratories84483171-df92-47de-9203-ed02d64fb5fb2018-12-31WarningsExact identifier
unii: ETJ7Z6XBU4
Hair-X Hair Loss ReliefCADMIUM SULFATE, GRAPHITE, PHOSPHORIC ACID, SILICON DIOXIDE, SELENIUM, THALLIUM, USTILAGO MAYDISHomeocare Laboratories00b62179-e03b-4972-902d-3a0c969b59bc2018-12-31WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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