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NDC 00781-1943-39 Amoxicillin and Clavulanate Potassium 562.5; 437.5; 62.5 mg/1; mg/1; mg/1 Details
Amoxicillin and Clavulanate Potassium 562.5; 437.5; 62.5 mg/1; mg/1; mg/1
Amoxicillin and Clavulanate Potassium is a ORAL TABLET, MULTILAYER, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Sandoz Inc. The primary component is AMOXICILLIN; AMOXICILLIN SODIUM; 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: 00781-1943-39Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Amoxicillin and Clavulanic Acid
Product Information
| NDC | 00781-1943 |
|---|---|
| Product ID | 0781-1943_5bd7896b-a564-4774-8149-e82ee34b988d |
| Associated GPIs | 01990002207420 |
| GCN Sequence Number | 050991 |
| GCN Sequence Number Description | amoxicillin/potassium clav TAB ER 12H 1000-62.5 ORAL |
| HIC3 | W1A |
| HIC3 Description | PENICILLIN ANTIBIOTICS |
| GCN | 91941 |
| 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 | TABLET, MULTILAYER, EXTENDED RELEASE |
| Route | ORAL |
| Active Ingredient Strength | 562.5; 437.5; 62.5 |
| Active Ingredient Units | mg/1; mg/1; mg/1 |
| Substance Name | AMOXICILLIN; AMOXICILLIN SODIUM; CLAVULANATE POTASSIUM |
| Labeler Name | Sandoz Inc |
| Pharmaceutical Class | Penicillin-class Antibacterial [EPC], Penicillin-class Antibacterial [EPC], Penicillins [CS], Penicillins [CS], beta Lactamase Inhibitor [EPC], beta Lactamase Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA090227 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00781-1943-39 (00781194339)
| NDC Package Code | 0781-1943-39 |
|---|---|
| Billing NDC | 00781194339 |
| Package | 40 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (0781-1943-39) |
| Marketing Start Date | 2010-04-21 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 5.00055 |
| Pricing Unit | EA |
| Effective Date | 2024-02-21 |
| NDC Description | AMOX-CLAV ER 1,000-62.5 MG TAB |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 1 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |