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 60 of 119 · 2,361 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sonni SunDay Invisible DefenseTITANIUM DIOXIDE, ZINC OXIDESonni41ad9658-7906-d04c-e063-6394a90a47232025-10-21WarningsExact identifier
unii: 15FIX9V2JP
Sonni SunDay Body BalmTITANIUM DIOXIDE, ZINC OXIDESonni41adca2e-cf69-ccd9-e063-6294a90a0dc02025-10-21WarningsExact identifier
unii: 15FIX9V2JP
e l f Camo Semi Matte CC SPF 30 Deep 530 WZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.940e0b2d-0b10-4534-ba36-e9980cead4922025-10-21WarningsExact identifier
unii: 15FIX9V2JP
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMPD-Rx Pharmaceuticals, Inc.e340b67b-332e-4e0c-aebf-ad4872dc5ed42025-10-20Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMPD-Rx Pharmaceuticals, Inc.cc445a39-d84c-4b76-9fb8-ae302e7cd96b2025-10-20Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINPD-Rx Pharmaceuticals, Inc.039d2677-b04f-436c-e063-6294a90ac5192025-10-20Warnings, Adverse reactionsExact identifier
rxcui: 308191
unii: 804826J2HU
Clinical Skin Filter Tinted SunscreenCLINICAL SKIN FILTER TINTED SUNSCREENKRX RESOURCES SDN. BHD.22b8856b-671f-def3-e063-6394a90a4ea02025-10-18WarningsExact identifier
unii: 15FIX9V2JP
Clinical Skin Filter Tinted Sunscreen Medium DarkCLINICAL SKIN FILTER TINTED SUNSCREEN MEDIUM DARKKRX RESOURCES SDN. BHD.22cead37-f862-e859-e063-6394a90a86ce2025-10-18WarningsExact identifier
unii: 15FIX9V2JP
Krx Aesthetics All Day Glow SunblockerKRX AESTHETICS ALL DAY GLOW SUNBLOCKERKRX RESOURCES SDN. BHD.22a60fb9-0fea-92c0-e063-6394a90a088c2025-10-18WarningsExact identifier
unii: 15FIX9V2JP
AmoxicillinAMOXICILLINPD-Rx Pharmaceuticals, Inc.d0938df9-9065-47eb-9eae-0722ed1411a12025-10-17Warnings, Adverse reactionsExact identifier
application number: ANDA065271
rxcui: 308191
unii: 804826J2HU
AmoxicillinAMOXICILLINPD-Rx Pharmaceuticals, Inc.987786a1-d748-4b42-abb5-62a2f38ef1952025-10-17Warnings, Adverse reactionsExact identifier
application number: ANDA065271
rxcui: 308191
unii: 804826J2HU
DD CreamDD CREAMDERMAdoctor, Inc.08c9a0cf-ee78-483b-e054-00144ff88e882025-10-16WarningsExact identifier
unii: 15FIX9V2JP
Ciele Filter and ProtectTITANIUM DIOXIDE, ZINC OXIDECiele0309b0ef-baca-b41d-e063-6294a90a49d72025-10-15WarningsExact identifier
unii: 15FIX9V2JP
Defend and Balance TInted Mineral Sunscreen SPF 50SUNSCREENEpicuren Discovery41367f05-59d8-6736-e063-6394a90a5f172025-10-15WarningsExact identifier
unii: 15FIX9V2JP
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMPD-Rx Pharmaceuticals, Inc.b04330a0-2b8d-4cf9-a08e-19007d1001ad2025-10-15Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMPD-Rx Pharmaceuticals, Inc.416fa58c-88fa-42aa-9195-74aeba6415772025-10-15Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMPD-Rx Pharmaceuticals, Inc.0425932a-f6e1-49a6-8480-720f179ace142025-10-14Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Skinlycious Multi Protection Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE , ZINC OXIDESkinlycious Pte Ltde0ad02c3-f5ed-4b72-ba96-07d9c489a4ea2025-10-13WarningsExact identifier
unii: 15FIX9V2JP
Vertra S Dorian Kona Gold Signature Face Stick SPF 38TITANIUM DIOXIDEEai-jr 286, Incb6c316c3-661b-6428-e053-2a95a90a1a6b2025-10-10WarningsExact identifier
unii: 15FIX9V2JP
AmoxicillinAMOXICILLINPD-Rx Pharmaceuticals, Inc.98e9274c-c02e-44d9-8cc5-17536ef03a772025-10-10Warnings, Adverse reactionsExact identifier
unii: 804826J2HU

Reported adverse events (FAERS/openFDA)#

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