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 17 of 119 · 2,365 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMA-S Medication Solutions77126eee-9534-4e80-9d11-ec78ec66c8262026-02-19Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMNuCare Pharmaceuticals,Inc.bcd19a89-e9dc-b85f-e053-2a95a90a6f3e2026-02-19Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.bd46de4c-4571-ba9a-e053-2a95a90a792d2026-02-19Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Allay Skin Solutions Protect Nourish Mineral Sunscreen SPF 42TITANIUM DIOXIDE, ZINC OXIDEALLAY SKIN SOLUTIONS LLC425bf1d7-f2cf-4237-9047-dd53054acd1c2026-02-18WarningsExact identifier
unii: 15FIX9V2JP
Hermes Plein Air-Baume de Teint Perfecteur Naturel-Enhancing Complexion Balm 85 TAMARINTITANIUM DIOXIDES.A. COMPTOIR NOUVEAU DE LA PARFUMERIEdacff3dc-49d7-6416-e053-2a95a90a85c62026-02-18WarningsExact identifier
unii: 15FIX9V2JP
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.f1eee459-9021-b26e-e053-2995a90a72912026-02-18Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMPD-Rx Pharmaceuticals, Inc.f229e8b4-7045-4c0d-9214-890c0bda3c2a2026-02-16Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMA-S Medication Solutionsa3d1c0bb-94f3-4cfb-a4c6-233cf7e519a42026-02-13Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMA-S Medication Solutions483f6fca-e04e-4086-aa44-a361322b811d2026-02-13Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINA-S Medication Solutions8bce45db-dea7-4090-9d64-8b11b08d963e2026-02-12Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.800f5fac-f2af-358f-e053-2a91aa0ad6a62026-02-10Warnings, Adverse reactionsExact identifier
application number: ANDA065271
rxcui: 308191
unii: 804826J2HU
Alumier MD Clear Shield Broad Spectrum SPF 42 SunscreenTITANIUM DIOXIDE, ZINC OXIDEAlumier Labsa9c970c8-b6e3-b0a1-e053-2a95a90a89c72026-02-09WarningsExact identifier
unii: 15FIX9V2JP
Hampton Sun SPF 50 MineralZINC OXIDE 19.5% TITANIUM DIOXIDE 4.00%S&C Hampton Sun LLCd6c33436-042e-44e8-8b55-98be6e2468792026-02-06WarningsExact identifier
unii: 15FIX9V2JP
SHISEIDO WASO COLOR-SMART DAY MOISTURIZEROCTINOXATE, TITANIUM DIOXIDEShiseido Americas Corporationf291f077-1c72-48fc-bb19-c20bdeaaa5962026-02-06WarningsExact identifier
unii: 15FIX9V2JP
SHISEIDO WASO COLOR-SMART DAY MOISTURIZEROCTINOXATE, TITANIUM DIOXIDEShiseido Americas Corporation54f63dd8-e77f-42e4-a6d3-61ab7beecf502026-02-06WarningsExact identifier
unii: 15FIX9V2JP
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMA-S Medication Solutions2a376d67-0bf2-43a1-8ca3-73f90689c3392026-02-06Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
SEYTU Body SunscreenTITANIUM DIOXIDE AND ZINC OXIDEOmnilife USA, Inc.c411e9a6-b2ea-446b-a886-b92c61736e6c2026-02-05WarningsExact identifier
unii: 15FIX9V2JP
SEYTU Facial SunscreenTITANIUM DIOXIDE AND ZINC OXIDEOmnilife USA, Inc.96fd37fb-c3ff-413f-b2c8-50754f320ecc2026-02-05WarningsExact identifier
unii: 15FIX9V2JP
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 BambooOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SASebfe03e7-614f-44b1-b1f1-78edc7e274cc2026-02-05WarningsExact identifier
unii: 15FIX9V2JP
SHISEIDO URBAN ENVIRONMENT oil-free MINERAL SUNSCREEN SPF 42TITANIUM DIOXIDE AND ZINC OXIDESHISEIDO AMERICAS CORPORATION86630e82-f249-4866-82dd-3e21feb266c42026-02-04WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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