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 |
|---|---|---|---|---|---|---|
| Amoxicillin and Clavulanate Potassium | AMOXICILLIN AND CLAVULANATE POTASSIUM | NorthStar Rx LLC | f0a6d21d-203f-4fde-b010-a2730b86b491 | 2024-07-09 | Warnings, Adverse reactions | ANDA201090 617423 617430 Q42OMW3AT8 804826J2HU |
| Amoxicillin | AMOXICILLIN | Rising Pharma Holdings, Inc. | bb7733f8-6aad-4273-84a0-ef472630203f | 2024-07-07 | Warnings, Adverse reactions | 804826J2HU |
| Terrestristat | ALFALFA, AVENA SATIVA, FUCUS VESICULOSUS, ARALIA QUINQUEFOLIA, NATRUM CARBONICUM, THYROIDINUM (SUIS), PINEAL GLAND (SUIS), RHODODENDRON CHRYSANTHUM, AGATE, ARGENTUM NITRICUM, CADMIUM IODATUM, CALCAREA PHOSPHORICA, CUPRUM METALLICUM, MERCURIUS CORROSIVUS, PHOSPHORICUM ACIDUM, PHOSPHORUS, QUARTZ, SILICEA, STRONTIUM CARBONICUM, HOLMIUM METALLICUM, RADIUM BROMATUM, TARENTULA CUBENSIS, URANIUM NITRICUM, X-RAY | Energique, Inc. | c3d2fd24-6b41-4c85-bd5f-c3306e97080e | 2024-07-03 | Warnings | ETJ7Z6XBU4 |
| Cough plus Bronchial | ANTIMONIUM TARTARICUM, ARUM TRIPHYLLUM, BADIAGA, BAPTISIA TINCTORIA, BRYONIA (ALBA), DROSERA (ROTUNDIFOLIA), ECHINACEA (ANGUSTIFOLIA), EUPATORIUM PERFOLIATUM, KALI BROMATUM, LUNG SUIS, PHOSPHORUS, PULSATILLA (PRATENSIS), SPONGIA TOSTA, STICTA PULMONARIA, SULPHUR IODATUM, URTICA URENS | Liddell Laboratories, Inc. | 801eba42-4217-46e9-8f3e-745da01a27b0 | 2024-07-01 | Warnings | ETJ7Z6XBU4 |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals,Inc. | 7ee6b6b6-ae5b-2e39-e053-2991aa0a2377 | 2024-06-28 | Warnings, Adverse reactions | 804826J2HU |
| Amoxicillin and Clavulanate Potassium | AMOXICILLIN AND CLAVULANATE POTASSIUM | A-S Medication Solutions | 46921419-9fae-4f51-b1b2-dc2e1ab04e8e | 2024-06-28 | Warnings, Adverse reactions | Q42OMW3AT8 804826J2HU |
| Argentum Quartz 6X | ARGENTUM QUARTZ 6X | True Botanica, LLC | 1acadf89-d222-9e16-e063-6294a90a80bc | 2024-06-26 | Warnings | ETJ7Z6XBU4 |
| Amoxicillin | AMOXICILLIN | Asclemed USA, Inc. | 830bb8fb-3743-463a-9317-3f83e3e105ac | 2024-06-26 | Warnings, Adverse reactions | 804826J2HU |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals,Inc. | 997650f9-7eff-64de-e053-2995a90a617b | 2024-06-20 | Warnings, Adverse reactions | 804826J2HU |
| Amoxicillin and Clavulanate Potassium | AMOXICILLIN AND CLAVULANATE POTASSIUM | NuCare Pharmaceuticals,Inc. | a0ff848d-230a-ab6b-e053-2a95a90a8bb8 | 2024-06-20 | Warnings, Adverse reactions | Q42OMW3AT8 804826J2HU |
| Amoxicillin | AMOXICILLIN | Aurobindo Pharma Limited | 99103779-6d2f-4e4b-9b7f-0b24d7c6bf4e | 2024-06-20 | Warnings, Adverse reactions | 804826J2HU |
| Amoxicillin and Clavulanate Potassium | AMOXICILLIN AND CLAVULANATE POTASSIUM | NuCare Pharmaceuticals,Inc. | 9263495c-310a-c20e-e053-2995a90a2e87 | 2024-06-19 | Warnings, Adverse reactions | Q42OMW3AT8 804826J2HU |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals,Inc. | 97a657a3-8238-f5f1-e053-2a95a90a7a7a | 2024-06-19 | Warnings, Adverse reactions | 804826J2HU |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals,Inc. | 8c3ba9cf-9a28-3965-e053-2a95a90a38ce | 2024-06-18 | Warnings, Adverse reactions | 804826J2HU |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals,Inc. | 8dba39df-5df8-31aa-e053-2a95a90adae1 | 2024-06-18 | Warnings, Adverse reactions | 804826J2HU |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals,Inc. | 8398f2c9-37ca-9b59-e053-2991aa0a2c11 | 2024-06-14 | Warnings, Adverse reactions | 804826J2HU |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals,Inc. | 8995ac88-a094-2d16-e053-2a95a90a9a26 | 2024-06-14 | Warnings, Adverse reactions | 804826J2HU |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals,Inc. | 8af9b9ee-8a64-53f5-e053-2a95a90a62a4 | 2024-06-14 | Warnings, Adverse reactions | 804826J2HU |
| Amoxicillin | AMOXICILLIN | NuCare Pharmaceuticals,Inc. | 8c3dd74c-872a-1ba1-e053-2a95a90a7cb3 | 2024-06-13 | Warnings, Adverse reactions | 804826J2HU |
| Amoxicillin and Clavulanate Potassium | AMOXICILLIN AND CLAVULANATE POTASSIUM | Asclemed USA, Inc. | a94cfba3-27ed-46a3-81ef-e9b80187c207 | 2024-06-13 | Warnings, Adverse reactions | Q42OMW3AT8 804826J2HU |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.