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NDC 53002-1369-03 Amoxicillin 400 mg/5mL Details
Amoxicillin 400 mg/5mL
Amoxicillin is a ORAL POWDER, FOR SUSPENSION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by RPK Pharmaceuticals, Inc.. The primary component is AMOXICILLIN.
MedlinePlus Drug Summary
Amoxicillin is used to treat certain infections caused by bacteria, such as pneumonia; bronchitis (infection of the airway tubes leading to the lungs); and infections of the ears, nose, throat, urinary tract, and skin. It is also used in combination with other medications to eliminate H. pylori, a bacteria that causes ulcers. Amoxicillin is in a class of medications called penicillin-like antibiotics. It works by stopping the growth of bacteria. Antibiotics such as amoxicillin will not work for colds, flu, and other viral infections. Taking antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.
Related Packages: 53002-1369-03Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Amoxicillin
Product Information
| NDC | 53002-1369 |
|---|---|
| Product ID | 53002-1369_c976f8cf-b453-44bc-908e-37a907d116de |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Amoxicillin |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Amoxicillin |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | POWDER, FOR SUSPENSION |
| Route | ORAL |
| Active Ingredient Strength | 400 |
| Active Ingredient Units | mg/5mL |
| Substance Name | AMOXICILLIN |
| Labeler Name | RPK Pharmaceuticals, Inc. |
| Pharmaceutical Class | Penicillin-class Antibacterial [EPC], Penicillins [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA065378 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 53002-1369-03 (53002136903)
| NDC Package Code | 53002-1369-3 |
|---|---|
| Billing NDC | 53002136903 |
| Package | 100 mL in 1 BOTTLE (53002-1369-3) |
| Marketing Start Date | 2018-10-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |