Prescription drug · ANDA
Amoxicillin and Clavulanate potassium NDC 69097-098
Amoxicillin 250 mg/5mL; Clavulanate potassium 62.5 mg/5mL · Suspension · Oral · Cipla USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69097-098-08 | 69097009808 | 150 mL in 1 BOTTLE (69097-098-08)Marketed from Oct 28, 2024 | |
| 69097-098-43 | 69097009843 | 75 mL in 1 BOTTLE (69097-098-43)Marketed from Oct 28, 2024 | |
| 69097-098-44 | 69097009844 | 100 mL in 1 BOTTLE (69097-098-44)Marketed from Oct 28, 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 — 250 mg/5mLClavulanate potassium — 62.5 mg/5mL
- Dosage form
- Suspension
- Route
- Oral
- Labeler
- Cipla USA Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065431
- Marketing start
- Listing expires
- Other FDA classes
- Penicillins (Chemical structure)beta Lactamase Inhibitors (Mechanism)
- Identifiers
- Product ID 69097-098_07e2bc58-0782-4cba-9e8d-fb9c906ab71eSPL ID 07e2bc58-0782-4cba-9e8d-fb9c906ab71eSPL set ID db25500a-90ee-429f-991f-da511cec7882RxCUI 617322UNII 804826J2HU, Q42OMW3AT8UPC 0369097098445, 0369097098087, 0369097098438
- 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
N469097009808followed by a unit qualifier and the quantityPackage 69097-0098-08. 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 Klebs…
Excerpt only. Read the full label for complete information.