Prescription drug · ANDA
Amoxicillin and Clavulanate Potassium NDC 68788-4179
Amoxicillin 400 mg/5mL; Clavulanic acid 57 mg/5mL · Powder, For suspension · Oral · Preferred Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-4179-1 | 68788417901 | 100 mL in 1 BOTTLE (68788-4179-1)Marketed from Jul 31, 2026 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 400 mg/5mLClavulanic acid — 57 mg/5mL
- Dosage form
- Powder, For suspension
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065191
- Marketing start
- Listing expires
- Other FDA classes
- Penicillins (Chemical structure)beta Lactamase Inhibitors (Mechanism)
- Identifiers
- Product ID 68788-4179_2c7a4de8-002a-472c-90d8-4c39a1f188c3SPL ID 2c7a4de8-002a-472c-90d8-4c39a1f188c3SPL set ID 2c7a4de8-002a-472c-90d8-4c39a1f188c3RxCUI 617430UNII 804826J2HU, 23521W1S24
- 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
N468788417901followed by a unit qualifier and the quantityPackage 68788-4179-01. 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 for Oral Suspension 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…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 065191
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 400 mg/5mL; Clavulanic acid 57 mg/5mL | Powder, For suspensionOral | NuCare Pharmaceuticals,Inc. | 68071-1619 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 400 mg/5mL; Clavulanic acid 57 mg/5mL | Powder, For suspensionOral | A-S Medication Solutions | 50090-0928 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 400 mg/5mL; Clavulanic acid 57 mg/5mL | Powder, For suspensionOral | Proficient Rx LP | 63187-826 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 200 mg/5mL; Clavulanic acid 28.5 mg/5mL | Powder, For suspensionOral | Hikma Pharmaceuticals USA Inc. | 0143-9981 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 400 mg/5mL; Clavulanic acid 57 mg/5mL | Powder, For suspensionOral | Hikma Pharmaceuticals USA Inc. | 0143-9982 |