Prescription drug · ANDA
Amoxicillin and Clavulanate Potassium NDC 45865-230
Amoxicillin 500 mg/1; Clavulanate potassium 125 mg/1 · Tablet, Film coated · Oral · Medsource Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 45865-230-20 | 45865023020 | 20 TABLET, FILM COATED in 1 BOTTLE (45865-230-20)Marketed from Nov 30, 2023 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Amoxicillin and Clavulanate Potassium
- Generic name (nonproprietary)
- amoxicillin and clavulanate potassium
- Active ingredients
- Amoxicillin — 500 mg/1Clavulanate potassium — 125 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Medsource Pharmaceuticals
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205707
- Marketing start
- Listing expires
- Other FDA classes
- Penicillins (Chemical structure)beta Lactamase Inhibitors (Mechanism)
- Identifiers
- Product ID 45865-230_1275ba9e-689e-104c-e063-6394a90a2b15SPL ID 1275ba9e-689e-104c-e063-6394a90a2b15SPL set ID 1275ad58-c53f-20d0-e063-6394a90a4a43RxCUI 617296UNII 804826J2HU, Q42OMW3AT8
- Pharmacologic class
- Penicillin-class Antibacterial; beta Lactamase Inhibitor
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N445865023020followed by a unit qualifier and the quantityPackage 45865-0230-20. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Amoxicillin and clavulanate potassium tablets are indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below: • Lower Respiratory Tract Infections - caused by beta‑lactamase‑producing isolates of Haemophilus influenzae and Moraxella catarrhalis . • Acute Bacterial Otitis Media - caused by beta‑lactamase‑producing isolates of H. influenzae and M. catarrhalis . • Sinusitis - caused by beta‑lactamase‑producing isolates of H. influenzae and M. catarrhalis . • Skin and Skin Structure Infections - caused by beta‑lactamase‑producing isolates of Staphylococcus aureus, Escherichia coli and Klebsiell…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 205707
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Amoxicillin And Clavulanate Potassium | Amoxicillin 500 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0366 |
| Amoxicillin And Clavulanate Potassium | Amoxicillin 250 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2896 |
| Amoxicillin And Clavulanate Potassium | Amoxicillin 500 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-7998 |
| Amoxicillin And Clavulanate Potassium | Amoxicillin 500 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-014 |
| Amoxicillin And Clavulanate Potassium | Amoxicillin 500 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | Micro Labs Limited | 42571-161 |
| Amoxicillin And Clavulanate Potassium | Amoxicillin 250 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | Micro Labs Limited | 42571-160 |
| Amoxicillin And Clavulanate Potassium | Amoxicillin 500 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-2625 |
| Amoxicillin And Clavulanate Potassium | Amoxicillin 500 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2824 |
| Amoxicillin And Clavulanate Potassium | Amoxicillin 500 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-4275 |
| Amoxicillin And Clavulanate Potassium | Amoxicillin 500 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-4284 |
| Amoxicillin And Clavulanate Potassium | Amoxicillin 500 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-4300 |
| Amoxicillin/Clav Pot | Clavulanate potassium 125 mg/1; Amoxicillin 500 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-638 |
| Amoxicillin And Clavulanate Potassium | Amoxicillin 500 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2433 |
| Amoxicillin And Clavulanate Potassium | Amoxicillin 250 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2435 |