Prescription drug · ANDA
Amoxicillin and Clavulanate Potassium NDC 73043-009
Amoxicillin 400 mg/5mL; Clavulanate potassium 57 mg/5mL · Powder, For suspension · Oral · Devatis, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 73043-009-01 | 73043000901 | 50 mL in 1 BOTTLE (73043-009-01)Marketed from Nov 1, 2024 | |
| 73043-009-02 | 73043000902 | 75 mL in 1 BOTTLE (73043-009-02)Marketed from Nov 1, 2024 | |
| 73043-009-03 | 73043000903 | 100 mL in 1 BOTTLE (73043-009-03)Marketed from Nov 1, 2024 |
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 — 400 mg/5mLClavulanate potassium — 57 mg/5mL
- Dosage form
- Powder, For suspension
- Route
- Oral
- Labeler
- Devatis, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210416
- Marketing start
- Listing expires
- Other FDA classes
- Penicillins (Chemical structure)beta Lactamase Inhibitors (Mechanism)
- Identifiers
- Product ID 73043-009_8942c376-8b1a-4716-9b90-de14ab22c4fbSPL ID 8942c376-8b1a-4716-9b90-de14ab22c4fbSPL set ID 90d0aa94-5c32-4fb7-8561-8763810d2847RxCUI 617430UNII 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
N473043000901followed by a unit qualifier and the quantityPackage 73043-0009-01. 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 Klebsie…
Excerpt only. Read the full label for complete information.