Search by Drug Name or NDC
NDC 65862-0534-50 Amoxicillin and Clavulanate Potassium 400; 57 mg/5mL; mg/5mL Details
Amoxicillin and Clavulanate Potassium 400; 57 mg/5mL; mg/5mL
Amoxicillin and Clavulanate Potassium is a ORAL POWDER, FOR SUSPENSION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Aurobindo Pharma Limited. The primary component is AMOXICILLIN; CLAVULANATE POTASSIUM.
MedlinePlus Drug Summary
The combination of amoxicillin and clavulanic acid is used to treat certain infections caused by bacteria, including infections of the ears, lungs, sinus, skin, and urinary tract. Amoxicillin is in a class of medications called penicillin-like antibiotics. It works by stopping the growth of bacteria. Clavulanic acid is in a class of medications called beta-lactamase inhibitors. It works by preventing bacteria from destroying amoxicillin. Antibiotics will not work for colds, flu, or other viral infections. Using antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.
Related Packages: 65862-0534-50Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Amoxicillin and Clavulanic Acid
Product Information
| NDC | 65862-0534 |
|---|---|
| Product ID | 65862-534_b8c128bc-86fe-445a-88f9-81883574cfa9 |
| Associated GPIs | 01990002201935 |
| GCN Sequence Number | 025898 |
| GCN Sequence Number Description | amoxicillin/potassium clav SUSP RECON 400-57MG/5 ORAL |
| HIC3 | W1A |
| HIC3 Description | PENICILLIN ANTIBIOTICS |
| GCN | 67153 |
| HICL Sequence Number | 003962 |
| HICL Sequence Number Description | AMOXICILLIN/POTASSIUM CLAVULANATE |
| Brand/Generic | Generic |
| Proprietary Name | Amoxicillin and Clavulanate Potassium |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Amoxicillin and Clavulanate Potassium |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | POWDER, FOR SUSPENSION |
| Route | ORAL |
| Active Ingredient Strength | 400; 57 |
| Active Ingredient Units | mg/5mL; mg/5mL |
| Substance Name | AMOXICILLIN; CLAVULANATE POTASSIUM |
| Labeler Name | Aurobindo Pharma Limited |
| Pharmaceutical Class | Penicillin-class Antibacterial [EPC], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA201090 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 65862-0534-50 (65862053450)
| NDC Package Code | 65862-534-50 |
|---|---|
| Billing NDC | 65862053450 |
| Package | 50 mL in 1 BOTTLE (65862-534-50) |
| Marketing Start Date | 2011-12-20 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.08588 |
| Pricing Unit | ML |
| Effective Date | 2024-02-21 |
| NDC Description | AMOX-CLAV 400-57 MG/5 ML SUSP |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 1, 5 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |