FDA.reportPublic FDA data

NDC 68071-2227-01 - Amoxicillin and Clavulanate Potassium

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
68071-2227
Requested NDC
68071-2227-01
Package NDCs from labels
68071-2227-1, 68071-2227-01
Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2025-01-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Amoxicillin and Clavulanate Potassium - NuCare Pharmaceuticals,Inc.NuCare Pharmaceuticals,Inc.2025-01-02HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2227-12022-02-04C16284748780-1d6a99b39-44a0-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION. AMOXICILLIN and CLAVULANATE potassium for oral suspension, USP Initial U.S. Approval: 1984 To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium for oral suspension and other antibacterial drugs, a
68071-2227-12022-01-28C16284748780-1d6a99b39-44a0-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION safely and effectively. See full prescribing information for AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION. AMOXICILLIN and CLAVULANATE potassium for oral suspension, USP Initial U.S. Approval: 1984 To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium for oral suspension and other antibacterial drugs, a

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2227-1Amoxicillin and Clavulanate Potassium100 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2227AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER, FOR SUSPENSION [NUCARE PHARMACEUTICALS,INC.]4Current NDC, Legacy NDC, 1 package rows20250104_abbebdc1-4410-76af-e053-2a95a90acb9c.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 30 of 50 · 981 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMNuCare Pharmaceuticals,Inc.abbebdc1-4410-76af-e053-2a95a90acb9c2025-01-02Warnings, Adverse reactionsExact identifier
application number: ANDA201090
ndc (package): 68071-2227-1
ndc (product): 68071-2227
ndc11 (package): 68071222701
rxcui: 617430
spl id: 2abf8f97-dbdd-887c-e063-6394a90a0691
spl set id: abbebdc1-4410-76af-e053-2a95a90acb9c
unii: Q42OMW3AT8
unii: 804826J2HU
MIMIBO PREMIUM TOOTHSILICON DIOXIDE, TOCOPHEROL ACETATE, TETRASODIUM PYROPHOSPHATECONE MEDICAL Co., Ltd.c0ff5df4-0b37-0b1b-e053-2a95a90a862c2025-01-02WarningsExact identifier
unii: ETJ7Z6XBU4
MIMIBO PREMIUM TOOTHSILICON DIOXIDE, TOCOPHEROL ACETATE, TETRASODIUM PYROPHOSPHATECONE MEDICAL Co., Ltd.c101881a-5a12-2e04-e053-2a95a90a3f572025-01-02WarningsExact identifier
unii: ETJ7Z6XBU4
NativeRemedies Acid Free-FluxCALC PHOS 9X, CARBO VEG 6C, MAG CARB 6C, NAT PHOS 9X, SILICEA 9XSilver Star Brandsd5012b1f-861e-40b8-e053-2a95a90a4fe22025-01-01WarningsExact identifier
unii: ETJ7Z6XBU4
Mucus Clear Allergy ReliefALLIU CEPA, CALC PHOS, EUPHRASIA, IGNATIA, KALI MUR, NAT MUR, NUX VOM, PULSATILLA, SILICASilver Star Brandsf49bdcc1-1939-6dc2-e053-2995a90a0a3b2025-01-01WarningsExact identifier
unii: ETJ7Z6XBU4
NativeRemedies Gout-GoneANTIMON CRUD, BENZOICUM AC, LEDUM, NUX VOM, QUERCUS, RHODODENDRON, SILICEASilver Star Brandsf66b42f0-8f5f-1aca-e053-2a95a90ae3962025-01-01WarningsExact identifier
unii: ETJ7Z6XBU4
NeuropathEaseAGARICUS MUSC, ARSENICUM ALB, HYPERICUM, PHOS, SILICEASilver Star Brands7809e54a-018d-9cf6-e053-2a91aa0aedfe2025-01-01WarningsExact identifier
unii: ETJ7Z6XBU4
AllergiClear-MADRENALINUM, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, KALI MURIATICUM, NATRUM MURIATICUM, SILICEASilver Star Brands9d36096b-022f-5cfa-e053-2995a90a381f2025-01-01WarningsExact identifier
unii: ETJ7Z6XBU4
AmoxicillinAMOXICILLINAdvanced Rx Pharmacy of Tennessee, LLCf4c36acc-828d-323b-e053-2a95a90a4d1c2024-12-31Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.5f8b3c58-ed9f-84a2-e053-2a91aa0ac8cf2024-12-27Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.5c60cb1c-3baf-3af2-e053-2a91aa0ae2082024-12-27Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.59a546ed-84b7-a54a-e053-2991aa0a3a0d2024-12-26Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINA-S Medication Solutionsaaf42367-153e-4525-af5f-f5f1c7d6c5592024-12-24Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Trace Mineral CordARGENTUM METALLICUM, AURUM METALLICUM, BORON CITRATE, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, CHROMIUM SULPHURICUM, COBALT GLUCONATE, CUPRUM SULPHURICUM, FERRUM PHOSPHORICUM, GERMANIUM SESQUIOXIDE, IODIUM, KALI BROMATUM, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, LITHIUM CARBONICUM, MAGNESIA PHOSPHORICA, MANGANUM MURIATICUM, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, SELENIUM METALLICUM, SILICEA, SODIUM MOLYBDATE, STRONTIUM CARBONICUM, VANADIUM METALLICUM,Energique, Inc.902dd68d-5ce1-481e-8938-6487dcc68dfc2024-12-19WarningsExact identifier
unii: ETJ7Z6XBU4
AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMBryant Ranch Prepackd7c0a364-d5d1-432d-823b-844a2d0b67802024-12-16Warnings, Adverse reactionsExact identifier
unii: Q42OMW3AT8
unii: 804826J2HU
AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMBryant Ranch Prepackb9bcd4a4-d4ae-4460-9eff-e80439fafd6f2024-12-16Warnings, Adverse reactionsExact identifier
unii: Q42OMW3AT8
unii: 804826J2HU
AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN AND CLAVULANATE POTASSIUMBryant Ranch Prepack9bd9e662-0b80-45a8-906b-3dc04ee6b3ba2024-12-16Warnings, Adverse reactionsExact identifier
unii: Q42OMW3AT8
unii: 804826J2HU
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMTeva Pharmaceuticals USA, Inc.e83f43dd-f79e-4166-9bee-9427e235c8762024-12-01Warnings, Adverse reactionsExact identifier
unii: Q42OMW3AT8
unii: 804826J2HU
GeovitaCEREBRUM, CUPRUM MET, FERRUM MET, FORMICUM ACIDUM, SILICEARUBIMED AG0fcb5c06-d414-456c-a0ef-28e14018a7812024-11-29WarningsExact identifier
unii: ETJ7Z6XBU4
Para-SiJUGLANS REG, ABROTANUM, AESCULUS HIPP, ALLIUM SAT, ARSENICUM ALB, ARTEMISIA, BAPTISIA, CINA, CUPRUM MET, FILIX MAS, GRANATUM, IPECAC, LACHESIS, LYCOPODIUM, MERC VIV, NAPHTHALINUM, NAT MUR, NUX VOM, PULSATILLA, RATANHIA, RUTA, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTH, TEREBINTHINA, TEUCRIUM MAR, THYMOLUM, ZINGIBERNewton Laboratories, Inc.27d41602-9dcb-eaa8-e063-6394a90a7cfa2024-11-26WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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