Prescription drug · ANDA
Amoxicillin and Clavulanate Potassium NDC 0781-1852
Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1 · Tablet, Film coated · Oral · Sandoz Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0781-1852-01 | 00781185201 | 100 TABLET, FILM COATED in 1 BOTTLE (0781-1852-01)Marketed from Sep 20, 2022 | |
| 0781-1852-13 | 00781185213 | 100 TABLET, FILM COATED in 1 BOX, UNIT-DOSE (0781-1852-13)Marketed from Mar 14, 2002 | |
| 0781-1852-20 | 00781185220 | 20 TABLET, FILM COATED in 1 BOTTLE (0781-1852-20)Marketed from Mar 14, 2002 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 875 mg/1Clavulanate potassium — 125 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Sandoz Inc
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065063
- Marketing start
- Listing expires
- Other FDA classes
- Penicillins (Chemical structure)beta Lactamase Inhibitors (Mechanism)
- Identifiers
- Product ID 0781-1852_6a6233c9-2bba-4d8c-9bfa-e5c5055cf91fSPL ID 6a6233c9-2bba-4d8c-9bfa-e5c5055cf91fSPL set ID 7cba82f0-9886-46e9-8dbd-43a448aade29RxCUI 562251, 562508, 617296, 617423, 617430UNII 804826J2HU, Q42OMW3AT8UPC 0307816102462, 0307811831206, 0307811874319, 0307811852201
- 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
N400781185201followed by a unit qualifier and the quantityPackage 00781-1852-01. 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 is 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 Klebsiella species…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 065063
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 875 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-2982 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-3866 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2211 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-651 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-712 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-488 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-501 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-3624 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-3822 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-3842 |