FDA.reportPublic FDA data

NDC 68071-1760-01 - 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
68071-1760
Requested NDC
68071-1760-01
Package NDCs from labels
68071-1760-1, 68071-1760-01
Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2024-12-27
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.2024-12-27HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-1760-12022-01-30C16284748780-1d6a99b39-efc3-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use AMOXICILLIN for Oral Suspension, USP safely and effectively. See full prescribing information for AMOXICILLIN for Oral Suspension, USP. AMOXICILLIN for Oral Suspension, USP, for oral use Dye free Rx Only Initial U.S. Approval: 1974 To reduce the development of drug-resistant bacteria and maintain the effectiveness of AMOXICILLIN and other antibacterial drugs, AMOXICILLIN should be used only to treat infections that are proven or strongly susp
68071-1760-12022-01-28C16284748780-1d6a99b39-efc3-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use AMOXICILLIN for Oral Suspension, USP safely and effectively. See full prescribing information for AMOXICILLIN for Oral Suspension, USP. AMOXICILLIN for Oral Suspension, USP, for oral use Dye free Rx Only Initial U.S. Approval: 1974 To reduce the development of drug-resistant bacteria and maintain the effectiveness of AMOXICILLIN and other antibacterial drugs, AMOXICILLIN should be used only to treat infections that are proven or strongly susp

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-1760-1Amoxicillin100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-1760AMOXICILLIN POWDER, FOR SUSPENSION [NUCARE PHARMACEUTICALS,INC.]5Current NDC, Legacy NDC, 1 package rows20241228_5f8b3c58-ed9f-84a2-e053-2a91aa0ac8cf.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 8 of 19 · 375 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AmoxicillinAMOXICILLINBryant Ranch Prepackbbaeb509-ad04-4668-a1db-4358038893f22025-10-23Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMBryant Ranch Prepackaa15e6f6-1eb1-41ab-b3cb-bf24d09fc8822025-10-23Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMBryant Ranch Prepackb5e66987-09e3-45b2-88ba-59c8647d724e2025-10-23Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMBryant Ranch Prepackeef98beb-57d9-448a-b89c-6acd6f7b443e2025-10-23Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
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
unii: 804826J2HU
AmoxicillinAMOXICILLINPD-Rx Pharmaceuticals, Inc.d0938df9-9065-47eb-9eae-0722ed1411a12025-10-17Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINPD-Rx Pharmaceuticals, Inc.987786a1-d748-4b42-abb5-62a2f38ef1952025-10-17Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
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
AmoxicillinAMOXICILLINPD-Rx Pharmaceuticals, Inc.98e9274c-c02e-44d9-8cc5-17536ef03a772025-10-10Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINPD-Rx Pharmaceuticals, Inc.b397d4be-d2ef-419a-98ac-844069c99d562025-10-08Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMNuCare Pharmaceuticals,Inc.9015d3dc-1ab4-2582-e053-2995a90a16792025-10-07Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMA-S Medication Solutions924a9ef6-5e3d-4e78-ae97-ae090f6613c02025-09-24Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMNorthStar Rx LLCd75b0a7e-cb9b-4102-bcac-097403b251292025-09-12Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.3e4f0f03-438b-ddfb-e063-6294a90adb382025-09-08Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINPreferred Pharmaceuticals Inc.9cad7ff5-5151-47d9-bc66-2ded25deefc22025-09-05Warnings, Adverse reactionsExact identifier
application number: ANDA065322
rxcui: 313797
unii: 804826J2HU
AmoxicillinAMOXICILLINRedpharm Drug3d0025b4-b7bb-69db-e063-6294a90a0e702025-08-23Warnings, Adverse reactionsExact identifier
unii: 804826J2HU

Reported adverse events (FAERS/openFDA)#

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