FDA.reportPublic FDA data

NDC 68071-4455-01 - 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
68071-4455
Requested NDC
68071-4455-01
Package NDCs from labels
68071-4455-7, 68071-4455-1, 68071-4455-8, 68071-4455-2, 68071-4455-3, 68071-4455-4, 68071-4455-6, 68071-4455-5, 68071-4455-0, 68071-4455-01
Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2025-01-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Amoxicillin - NuCare Pharmaceuticals,Inc.NuCare Pharmaceuticals,Inc.2025-01-08HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
68071-4455-12021-02-10These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
68071-4455-22021-02-10These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
68071-4455-32021-02-10These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
68071-4455-42021-02-10These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
68071-4455-62021-02-10These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
68071-4455-72021-02-10These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
68071-4455-82021-02-10These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
68071-4455-12021-01-29These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
68071-4455-22021-01-29These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
68071-4455-32021-01-29These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
68071-4455-42021-01-29These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
68071-4455-62021-01-29These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
68071-4455-72021-01-29These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974
68071-4455-82021-01-29These highlights do not include all the information needed to use AMOXICILLIN CAPSULES safely and effectively. See full prescribing information for AMOXICILLIN CAPSULES. AMOXICILLIN capsules, for oral use Initial U.S. Approval: 1974

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4455-0Amoxicillin10 in 1 BOTTLECAPSULE108
68071-4455-1Amoxicillin21 in 1 BOTTLECAPSULE218
68071-4455-2Amoxicillin20 in 1 BOTTLECAPSULE208
68071-4455-3Amoxicillin30 in 1 BOTTLECAPSULE308
68071-4455-4Amoxicillin40 in 1 BOTTLECAPSULE408
68071-4455-5Amoxicillin56 in 1 BOTTLECAPSULE568
68071-4455-6Amoxicillin60 in 1 BOTTLECAPSULE608
68071-4455-7Amoxicillin15 in 1 BOTTLECAPSULE158
68071-4455-8Amoxicillin28 in 1 BOTTLECAPSULE288

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4455AMOXICILLIN CAPSULE [NUCARE PHARMACEUTICALS,INC.]8Current NDC, Legacy NDC, 9 package rows20250110_6d7143e3-6a82-3613-e053-2a91aa0a8f65.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 4 of 120 · 2,397 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AmoxicillinAMOXICILLINPreferred Pharmaceuticals Inc.ad804b34-169c-44bf-a469-f1149433d96b2026-07-15Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMHAWAII REPACK, INC.7fb0f56e-c098-49e4-b075-2eb8936582aa2026-07-13Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINPD-Rx Pharmaceuticals, Inc.96057ce7-9516-4239-9974-5e9691b44c9b2026-07-09Warnings, Adverse reactionsExact identifier
rxcui: 308191
unii: 804826J2HU
AmoxicillinAMOXICILLINNorthwind Health Company, LLC1d0d8bc4-137e-ef10-e063-6294a90acf622026-07-09Warnings, Adverse reactionsExact identifier
application number: ANDA065271
rxcui: 308191
unii: 804826J2HU
AmoxicillinAMOXICILLINNorthwind Health Company, LLC26e257d5-5b98-3795-e063-6394a90a05bc2026-07-09Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINNorthwind Health Company, LLC4ecefd37-9847-1d93-e063-6394a90a19f02026-07-09Warnings, Adverse reactionsExact identifier
rxcui: 308182
unii: 804826J2HU
Bombee Honey Daily Glow Shield SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDEABT ASIA Inc.56112dff-b091-7a56-e063-6294a90a77d32026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DERMIO DERMATOLOGY LLC562f5b0d-6a10-305d-e063-6394a90a59802026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30Suzanne's Skin2soul LLC562fbaa6-f93a-5ec4-e063-6294a90a96342026-07-08WarningsExact identifier
unii: 15FIX9V2JP
AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMUSAntibiotics, LLC7d4dfd6f-bd1a-4acc-8506-07fca08f8a382026-07-07Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINUSAntibiotics, LLC06e5c07d-d95c-4955-8d35-a4703ca2359e2026-07-07Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMUSAntibiotics, LLC45c60b69-1b65-01ed-e063-6294a90a57be2026-07-07Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AUGMENTIN ES-600AMOXICILLIN AND CLAVULANATE POTASSIUMUSAntibiotics, LLC59979859-8c9b-4173-a5e3-2e6312fd9d792026-07-07Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Aussie Betta Tallow Sunscreen SPF50 SPF50TITANIUM DIOXIDE AND ZINC OXIDE SUNSCREENAUSSIE BETTA HEALTHY CARE PTY LTD56007d82-ff5b-6c26-e063-6294a90a09b62026-07-07WarningsExact identifier
unii: 15FIX9V2JP
EELHOE Body Coverage PerfectorTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.5610c3b7-456b-3bc1-e063-6394a90a3fa82026-07-07WarningsExact identifier
unii: 15FIX9V2JP
Premier Tinted Mineral SunscreenBROAD SPECTRUM SPF30Emerald Aesthetics LLC55f88dd1-346c-22a5-e063-6294a90a711f2026-07-06WarningsExact identifier
unii: 15FIX9V2JP
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMA-S Medication Solutionsce488c24-2ec5-4d1b-b446-90f2497aa15d2026-07-06Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINHAWAII REPACK, INC.669a243e-249d-4ccb-9693-66de073e53bb2026-07-03Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
OHUI Ultimate Cover CC Cushion Compact 02 Natural BeigeTITANIUM DIOXIDELG H&H Co., Ltd.d307471c-6cc6-ce48-e053-2995a90a3e022026-07-02WarningsExact identifier
unii: 15FIX9V2JP
Evereden Fluid Silk Mineral Sunscreen PRO SPF50TITANIUM DIOXIDE, ZINC OXIDEEden Brands Inc.2cb7773f-9a05-ad02-e063-6294a90af0242026-07-01WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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