NDC 85534-0040-01 - 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
85534-0040
Requested NDC
85534-0040-01
Package NDCs from labels
85534-0040-0, 85534-0040-1, 85534-0040-2, 85534-0040-3, 85534-0040-4, 85534-0040-5, 85534-0040-6, 85534-0040-7, 85534-0040-01
Manufacturer
HAWAII REPACK, INC. | ASCLEMED USA INC. DBA ENOVACHEM
Effective date
2026-07-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Amoxicillin - HAWAII REPACK, INC. | ASCLEMED USA INC. DBA ENOVACHEMHAWAII REPACK, INC. | ASCLEMED USA INC. DBA ENOVACHEM2026-07-17HUMAN 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 16 of 120 · 2,397 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AmoxicillinAMOXICILLINPreferred Phamraceuticals Inc.47424822-14a1-48e0-a62d-df34fe6857262026-03-04Warnings, Adverse reactionsExact identifier
application number: ANDA065271
rxcui: 308191
unii: 804826J2HU
AmoxicillinAMOXICILLINPreferred Pharmaceuticals Inc.573fcf4a-2b87-45d9-ac73-e1dec4fbc28b2026-03-04Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMPreferred Pharmaceuticals, Inc.22a387bd-92ce-4ebc-b475-20d7750a25072026-03-04Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINPreferred Pharmaceuticals Inc.8dfbaa75-87ba-4a6b-a2db-176441a842af2026-03-04Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMPreferred Pharmaceuticals Inc.1b8a6312-ae47-45fb-ba5e-eedbc176afa02026-03-03Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINPreferred Pharmaceuticals Inc.d6a33b28-f520-4a4c-b553-0ebd005583452026-03-03Warnings, Adverse reactionsExact identifier
application number: ANDA065271
rxcui: 308182
unii: 804826J2HU
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMPreferred Pharmaceuticals Inc.d23b6952-5e4c-4103-9fe0-a916b1e2e1b92026-03-03Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMPreferred Pharmaceuticals Inc.618953a3-0256-42ce-9155-d35325f017aa2026-03-02Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMPreferred Pharmaceuticals Inc.56fb634c-3725-4d0a-8f20-584652a1d99f2026-03-02Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINHikma Pharmaceuticals USA Inc.4fb7837e-964c-4d38-a3a5-b384b1bd6e082026-03-01Warnings, Adverse reactionsExact identifier
rxcui: 308191
unii: 804826J2HU
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMPreferred Pharmaceuticals Inc.30446852-9a54-4d16-ba12-56ffd01499852026-02-27Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
TIBENA EVERY DAY REAL SUN BLOCKTITANIUM DIOXIDE, ZINC OXIDEKONAD CO LTD211c9930-4f91-cf8f-e063-6394a90a97b32026-02-26WarningsExact identifier
unii: 15FIX9V2JP
CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION MATTE M B10TITANIUM DIOXIDEShiseido Americas Corporation54f8210f-4934-4ada-89c3-aa89e7a092602026-02-26WarningsExact identifier
unii: 15FIX9V2JP
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMPD-Rx Pharmaceuticals, Inc.d213685c-5e67-4130-b00b-7626685dfa162026-02-26Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
SHISEIDO UV PROTECTIVE COMPACT (REFILL) FAIR IVORYOCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONc05cef12-a6a7-4682-9357-6d77f4ca32672026-02-25WarningsExact identifier
unii: 15FIX9V2JP
cle de peau BEAUTE RADIANT FOUNDATION N M I10OCTINOXATE AND TITANIUM DIOXIDEShiseido Americas Corporation3be1fe06-bd3b-4078-bee9-d3caf8d068ff2026-02-25WarningsExact identifier
unii: 15FIX9V2JP
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMPD-Rx Pharmaceuticals, Inc.6a078e7d-f942-4185-a131-50215d8e0a1e2026-02-25Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
cle de peau BEAUTE THE FOUNDATION N M O20OCTINOXATE AND TITANIUM DIOXIDEShiseido Americas Corporation9507f6d1-c11c-428d-8d95-b436f27ba26a2026-02-24WarningsExact identifier
unii: 15FIX9V2JP
Perfect Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESKIN PERFECT MEDICAL4b93538a-3b3e-90f7-e063-6294a90ab8982026-02-24WarningsExact identifier
unii: 15FIX9V2JP
ANTI-AGING TINTED SUNSCREENTITANIUM DIOXIDE, ZINC OXIDELASER GIRL SKINCARE, LLC4b93cd22-1289-29bc-e063-6294a90ab7812026-02-24WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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