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 18 of 51 · 1,009 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GermasodeARNICA MONTANA, ECHINACEA ANGUSTIFOLIA, ARSENICUM ALBUM, BELLADONNA, BERBERIS VULGARIS, BORRELIA, CHLAMYDIA, HYDRASTIS CANADENSIS, LACHESIS MUTUS, LYMPHOGRANULOMA, MERCURIUS SOLUBILIS, OOPHORINUM, PHOSPHORUS, PNEUMOCOCCINUM, PYROGENIUM, SILICEA TERRANatural Creations, Inccad24325-e658-4427-a2e7-f821f01111702025-12-12WarningsExact identifier
unii: ETJ7Z6XBU4
HEADACHE HPSILVER NITRATE, ATROPA BELLADONNA, BRYONIA ALBA ROOT, GELSEMIUM SEMPERVIRENS ROOT, NITROGLYCERIN, LACHESIS MUTA VENOM, LYCOPODIUM CLAVATUM SPORE, MELILOTUS OFFICINALIS TOP, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, SILICON DIOXIDE, SPIGELIA ANTHELMIANatural Creations, Inc.c38b83f0-3918-4ef6-8dfd-48fe438e584a2025-12-12WarningsExact identifier
unii: ETJ7Z6XBU4
Cell WellCALCIUM CARBONICA,CALCIUM FLUORATUM,CALCIUM PHOSPHORICUM,CALCIUM SULPHURICUM,FERRUM PHOSPHORICUM,KALIUM MURIATICUM,KALIUM PHOSPHORICUM,KALIUM SULPHURICUM,MAGNESIUM CARBONICA,MAGNESIUM PHOSPHORICUM,NATRUM MURIATICUM,NATRUM PHOSPHORICUM,NATRUM SULPHURICUM,SILICEAJoyWell Co LLC592c1f48-21c8-4ff5-8818-046662c9effe2025-12-11WarningsExact identifier
unii: ETJ7Z6XBU4
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMNuCare Pharmaceuticals,Inc.ef2c7783-e419-288f-e053-2a95a90a628a2025-12-11Warnings, Adverse reactionsExact identifier
unii: Q42OMW3AT8
unii: 804826J2HU
DIZZINESS HPOYSTER SHELL CALCIUM CARBONATE CRUDE, CHENOPODIUM AMBROSIOIDES, ANAMIRTA COCCULUS SEED, CONIUM MACULATUM FLOWERING TOP, STRYCHNOS NUX-VOMICA SEED, PHOSPHORUS, PULSATILLA VULGARIS, SILICON DIOXIDENatural Creations, Inc.9701096b-5efa-4acd-9227-339ecedfd6722025-12-10WarningsExact identifier
unii: ETJ7Z6XBU4
AmoxicillinAMOXICILLINASCLEMED USA INC.08100595-e6de-4a8a-a177-a94f849bbe9f2025-12-10Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINAsclemed USA, Inc.32b224c2-1354-4b58-b082-b93330e6962b2025-12-10Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINQPharma, Inc.2700df91-c5ef-4931-9ad7-a3c1c146ccac2025-12-09Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Secale QuartzSECALE QUARTZUriel Pharmacy Inc.1e9f55d7-22d5-4412-ac35-b4400bdf29a02025-12-08WarningsExact identifier
unii: ETJ7Z6XBU4
AmoxicillinAMOXICILLINQPharma Inc2772a745-1276-405b-b229-95edf5534b2a2025-12-05Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINNuCare Pharmaceuticals, Inc.4528f48d-5bda-b307-e063-6294a90a294c2025-12-04Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
BM BIO28 ICING SUGARCALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEABM Private Limited3e855f3b-c73d-a153-e063-6394a90ad63a2025-12-02WarningsExact identifier
unii: ETJ7Z6XBU4
Bestmade Natural Products Bio28CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro3e85a931-57f6-2a55-e063-6294a90ac1802025-12-02WarningsExact identifier
unii: ETJ7Z6XBU4
Bestmade Natural Products BIO28CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEATotal Operations Management LLC DBA: Bestmade Natural Products Micro3e46ee90-2c2c-0a70-e063-6294a90a576a2025-12-02WarningsExact identifier
unii: ETJ7Z6XBU4
BM SiliceaSILICEABM Private Limited37b0535d-6bcf-2d40-e063-6294a90a2a8e2025-12-02WarningsExact identifier
unii: ETJ7Z6XBU4
BM Silicea Icing SugarSILICEA ICING SUGARBM Private Limited37c1f61d-dfe4-9dcf-e063-6394a90aceb12025-12-02WarningsExact identifier
unii: ETJ7Z6XBU4
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.8e6f9df1-0754-69e4-e053-2a95a90acc492025-12-02Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Bambusa PulsatillaBAMBUSA PULSATILLAUriel Pharmacy Inc.0776c3be-088d-422c-9c12-08fcaae823e12025-11-26WarningsExact identifier
unii: ETJ7Z6XBU4
Thyroid-AdrenalADRENALINUM, THYROIDINUM, ALOE, CALC. CARB., CHELIDONIUM MAJUS, CONIUM, GRAPHITES, IODIUM, LACHESIS, LYCOPODIUM, LYCOPUS VIRGINICUS, PHYTOLACCA, RHUS TOXICODENDRON, SILICEA, SPONGIA, ECHINACEANewton Laboratories, Inc.b597504a-c667-225c-e053-2a95a90ac7042025-11-25WarningsExact identifier
unii: ETJ7Z6XBU4
DOCTRUST ONE S ToothSODIUM FLUORIDE, DENTAL TYPE SILICA, POTASSIUM NIRATEDONG IL PHARMS CO.,LTD4476923a-48f1-9f72-e063-6394a90a07082025-11-25WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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