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 | 6909700980869097009808 | 150 mL in 1 BOTTLE (69097-098-08)Marketed from Oct 28, 2024 | |
| 69097-098-43 | 6909700984369097009843 | 75 mL in 1 BOTTLE (69097-098-43)Marketed from Oct 28, 2024 | |
| 69097-098-44 | 6909700984469097009844 | 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.NDC labeler code 69097
- 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.
About NDC 69097-098
- What is NDC 69097-098?
- 69097-098 is the product NDC for Amoxicillin and Clavulanate potassium, Amoxicillin 250 mg/5mL; Clavulanate potassium 62.5 mg/5mL suspension, listed with the FDA by Cipla USA Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Amoxicillin and Clavulanate potassium.
- What is the active ingredient?
- Amoxicillin, Clavulanate potassium.
- Who is the labeler?
- Cipla USA Inc., NDC labeler code 69097. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Amoxicillin and Clavulanate potassium?
- 200 other product NDCs are listed under this name. See all Amoxicillin and Clavulanate potassium NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Amoxicillin and Clavulanate potassium products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Amoxicillin And Clavulanate Potassium | Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1 | Tablet, CoatedOral | REMEDYREPACK INC. | 70518-4758 | 70518-4758-00 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 400 mg/5mL; Clavulanic acid 57 mg/5mL | Powder, For suspensionOral | Preferred Pharmaceuticals Inc. | 68788-4179 | 68788-4179-01 |
| Amoxicillin And Clavulanate Potassium | Amoxicillin 500 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0366 | 67046-0366-03 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0955 | 67046-0955-03 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 562.5 mg/1 + 2 more ingredients | Tablet, Film coated, Extended releaseOral | USAntibiotics, LLC | 81964-220 | 81964-0220-2881964-0220-40 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4424 | 70518-4424-00 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8836 | 68788-8836-02 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 600 mg/5mL; Clavulanate potassium 42.9 mg/5mL | SuspensionOral | Preferred Pharmaceuticals Inc. | 68788-8770 | 68788-8770-0168788-8770-07 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | Devatis, Inc. | 73043-006 | 73043-0006-20 |
| Amoxicillin and Clavulanate Potassium | Amoxicillin 500 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | Devatis, Inc. | 73043-007 | 73043-0007-20 |