NDC 85534-0080-01 - 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
- 85534-0080
- Requested NDC
- 85534-0080-01
- Package NDCs from labels
- 85534-0080-0, 85534-0080-1, 85534-0080-2, 85534-0080-01
- Manufacturer
- HAWAII REPACK, INC.
- Effective date
- 2026-07-13
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Amoxicillin and Clavulanate Potassium - HAWAII REPACK, INC. | HAWAII REPACK, INC. | 2026-07-13 | HUMAN PRESCRIPTION DRUG LABEL |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Spinalmax | BERBERIS VULGARIS, CIMICIFUGA RACEMOSA, CINCHONA OFFICINALIS, COLOCYNTHIS, LEDUM PALUSTRE, RANUNCULUS BULBOSUS, AESCULUS HIPPOCASTANUM, CUPRUM ACETICUM, NADIDUM, NATRUM OXALACETICUM, NICOTINAMIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, THIAMINUM HYDROCHLORICUM, ALPHA-LIPOICUM ACIDUM, AMMONIUM MURIATICUM, CARTILAGO SUIS, DISCUS INTERVERTEBRALIS (SUIS), PICRICUM ACIDUM, SILICEA, ARGENTUM METALLICUM, CALCAREA PHOSPHORICA, FUNICULUS UMBILICALIS SUIS, GLANDULA SUPRARENALIS SUIS, GNAPHALIUM POLYCEPHALUM | Deseret Biologicals, Inc. | 6c569331-2167-44bb-ace6-13340e7d8d6a | 2024-03-11 | Warnings | ETJ7Z6XBU4 |
| Perfect Sleep | ADENOSINUM TRIPHOSPHORICUM DINATRUM, ARSENICUM ALBUM, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, DYSENTERY BACILLUS, GAERTNER BACILLUS (BACH), L-TRYPTOPHAN, MELATONIN, MERCURIUS CORROSIVUS, PANTOTHENIC ACID, PASSIFLORA INCARNATA, PINEAL GLAND (SUIS), PYRROLE, SARCOLACTICUM ACIDUM, SILICEA, UBIDECARENONUM, ZINCUM VALERIANICUM | Deseret Biologicals, Inc. | 81f29472-a2e6-486d-aefd-17135ad410ef | 2024-03-08 | Warnings | ETJ7Z6XBU4 |
| Amoxicillin | AMOXICILLIN | NorthStar Rx LLC | 843f6053-63d9-47d2-81f1-b6aa78a7c20c | 2024-03-02 | Warnings, Adverse reactions | 804826J2HU |
| AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN AND CLAVULANATE POTASSIUM | Medsource Pharmaceuticals | 12a00e7e-80f5-7c5e-e063-6394a90a68d2 | 2024-03-01 | Warnings, Adverse reactions | Q42OMW3AT8 804826J2HU |
| Amoxicillin | AMOXICILLIN | Proficient Rx LP | 6a9cfa97-3715-4b75-a1e3-932a34a942d4 | 2024-03-01 | Warnings, Adverse reactions | 804826J2HU |
| Amoxicillin and Clavulanate Potassium | AMOXICILLIN AND CLAVULANATE POTASSIUM | Medsource Pharmaceuticals | 1275ad58-c53f-20d0-e063-6394a90a4a43 | 2024-02-28 | Warnings, Adverse reactions | Q42OMW3AT8 804826J2HU |
| Amoxicillin | AMOXICILLIN | Hikma Pharmaceuticals USA Inc. | c8591c2a-92ef-4432-b19a-bb46063047ee | 2024-02-28 | Warnings, Adverse reactions | 804826J2HU |
| Amoxicillin | AMOXICILLIN | Rising Pharma Holdings, Inc. | bbe590a0-4196-4885-b679-cc1833af567f | 2024-02-27 | Warnings, Adverse reactions | 804826J2HU |
| Amoxicillin | AMOXICILLIN | Sandoz Inc | 13bd4214-9b7f-425b-af5f-fc1ddc678230 | 2024-02-22 | Warnings, Adverse reactions | 804826J2HU |
| Kidney Drainage | SOLIDAGO VIRGAUREA, ASPARAGUS OFFICINALIS, JUNIPERUS COMMUNIS, SABAL SERRULATA, UVA-URSI, BERBERIS VULGARIS, EQUISETUM ARVENSE, URTICA DIOICA, RUBIA TINCTORUM, STAPHYSAGRIA, CANTHARIS, FAGUS SYLVATICA, FLOS, GLANDULA SUPRARENALIS SUIS, HEPAR SULPHURIS CALCAREUM, KIDNEY (SUIS), LARIX DECIDUA, FLOS, MANGANUM METALLICUM, MIMULUS GUTTATUS, FLOS, NITRICUM ACIDUM, RHUS AROMATICA, SILICEA, ULEX EUROPAEUS, FLOS, BENZOICUM ACIDUM, COBALTUM METALLICUM | Deseret Biologicals, Inc. | a030afc6-9248-4e6a-a814-bd700c053e5c | 2024-02-20 | Warnings | ETJ7Z6XBU4 |
| Cough | IPECACUANHA, STICTA PULMONARIA, PHOSPHORUS, ANTIMONIUM TARTARICUM, KREOSOTUM, ACONITUM NAPELLUS, BRYONIA (ALBA), HYOSCYAMUS NIGER, SILICEA, TABACUM, PERTUSSINUM, TETANUS TOXIN | Deseret Biologicals, Inc. | 4a8deb4a-9f26-46a9-8d99-99df36407f22 | 2024-02-19 | Warnings | ETJ7Z6XBU4 |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals,Inc. | 116f655e-e32f-5030-e063-6394a90a64e5 | 2024-02-15 | Warnings, Adverse reactions | 804826J2HU |
| Perfect Sleep | ADENOSINUM TRIPHOSPHORICUM DINATRUM, PANTOTHENIC ACID, PINEAL GLAND (SUIS), SARCOLACTICUM ACIDUM, UBIDECARENONUM, L-TRYPTOPHAN, MELATONIN, PYRROLE, ARSENICUM ALBUM, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, MERCURIUS CORROSIVUS, PASSIFLORA INCARNATA, SILICEA, ZINCUM VALERIANICUM, DYSENTERY BACILLUS, GAERTNER BACILLUS (BACH) | Deseret Biologicals, Inc. | 6d934960-63c6-4536-bde3-38c26f8083dc | 2024-02-06 | Warnings | ETJ7Z6XBU4 |
| AMOXICILLIN AND CLAVULANATE POTASSIUM | AMOXICILLIN AND CLAVULANATE POTASSIUM | Proficient Rx LP | 0d40bc70-8f47-48c2-a7c6-ba7db9cace74 | 2024-02-01 | Warnings, Adverse reactions | Q42OMW3AT8 804826J2HU |
| Amoxicillin | AMOXICILLIN | Hikma Pharmaceuticals USA Inc. | d46f1091-33dc-4f8f-9c34-75dcfedb4b4c | 2024-02-01 | Warnings, Adverse reactions | 804826J2HU |
| Amoxicillin | AMOXICILLIN | Hikma Pharmaceuticals USA Inc. | 077f4a65-3cfb-4cb1-99f2-e27ffc5939c0 | 2024-02-01 | Warnings, Adverse reactions | 804826J2HU |
| Silicea | SILICON DIOXIDE | SEVENE USA | 0805d866-ce1a-4f54-8a44-83d4902e8c0d | 2024-01-30 | Warnings | ETJ7Z6XBU4 |
| Amoxicillin | AMOXICILLIN | Aurobindo Pharma Limited | 7e3a4517-1934-4e03-b96b-4ad65ab076c5 | 2024-01-23 | Warnings, Adverse reactions | 804826J2HU |
| Sleep Tight | ADENOSINUM TRIPHOSPHORICUM DINATRUM, PANTOTHENIC ACID, PINEAL GLAND (SUIS), SARCOLACTICUM ACIDUM, UBIDECARENONUM, L-TRYPTOPHAN, MELATONIN, PYRROLE, ARSENICUM ALBUM, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, MERCURIUS CORROSIVUS, PASSIFLORA INCARNATA, SILICEA, ZINCUM VALERIANICUM, DYSENTERY BACILLUS, GAERTNER BACILLUS (BACH) | Dr. Donna Restivo DC | b5955fbc-71f8-4fe0-9df0-42f337ab9c7d | 2024-01-18 | Warnings | ETJ7Z6XBU4 |
| AMOXICILLIN | AMOXICILLIN | DIRECT RX | 0173e9de-a995-4386-bb65-8fc2bbf347f9 | 2024-01-09 | Warnings, Adverse reactions | 804826J2HU |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.