Prescription drug · ANDA
Amoxicillin And Clavulanate Potassium NDC 70518-2263
Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1 · Tablet, Film coated · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-2263-0 | 7051822630070518226300 | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-2263-0)Marketed from Aug 12, 2019 | |
| 70518-2263-1 | 7051822630170518226301 | 20 TABLET, FILM COATED in 1 BLISTER PACK (70518-2263-1)Marketed from Aug 12, 2019 | |
| 70518-2263-2 | 7051822630270518226302 | 14 TABLET, FILM COATED in 1 BLISTER PACK (70518-2263-2)Marketed from Dec 12, 2019 | |
| 70518-2263-3 | 7051822630370518226303 | 100 POUCH in 1 BOX (70518-2263-3) / 1 TABLET, FILM COATED in 1 POUCH (70518-2263-4)Marketed from Nov 17, 2021 | |
| 70518-2263-7 | 7051822630770518226307 | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-2263-7)Marketed from Sep 14, 2022 | |
| 70518-2263-8 | 7051822630870518226308 | 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2263-8)Marketed from Mar 14, 2023 | |
| 70518-2263-9 | 7051822630970518226309 | 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2263-9)Marketed from Apr 4, 2023 |
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 — 875 mg/1Clavulanate potassium — 125 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- REMEDYREPACK INC.NDC labeler code 70518
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204755
- Marketing start
- Listing expires
- Other FDA classes
- Penicillins (Chemical structure)beta Lactamase Inhibitors (Mechanism)
- Identifiers
- Product ID 70518-2263_5a584471-a6d1-38bb-e063-6394a90ab246SPL ID 5a584471-a6d1-38bb-e063-6394a90ab246SPL set ID a26f2ceb-bb9b-4813-9691-634338186860RxCUI 562508UNII 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
N470518226300followed by a unit qualifier and the quantityPackage 70518-2263-00. 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 tablets are 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 Klebsiel…
Excerpt only. Read the full label for complete information.
About NDC 70518-2263
- What is NDC 70518-2263?
- 70518-2263 is the product NDC for Amoxicillin And Clavulanate Potassium, Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1 tablet, film coated, listed with the FDA by REMEDYREPACK INC.. It has 7 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?
- REMEDYREPACK INC., NDC labeler code 70518. 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 |
Other NDCs under ANDA 204755
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 | Micro Labs Limited | 42571-162 |
| Amoxicillin And Clavulanate Potassium | Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | Medsource Pharmaceuticals | 45865-227 |
| Amoxicillin And Clavulanate Potassium | Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-3402 |
| Amoxicillin And Clavulanate Potassium | Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-4224 |
| Amoxicillin And Clavulanate Potassium | Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-4549 |
| Amoxicillin And Clavulanate Potassium | Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-7531 |
| Amoxicillin And Clavulanate Potassium | Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-3967 |
| Amoxicillin And Clavulanate Potassium | Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-331 |
| Amoxicillin And Clavulanate Potassium | Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2917 |
| Amoxicillin And Clavulanate Potassium | Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2434 |
| Amoxicillin And Clavulanate Potassium | Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-005 |
| Amoxicillin and Clavulanate Potassium | Clavulanate potassium 125 mg/1; Amoxicillin 875 mg/1 | Tablet, Film coatedOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0180 |
| Amoxicillin And Clavulanate Potassium | Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 82868-002 |
| Amoxicillin And Clavulanate Potassium | Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1 | Tablet, Film coatedOral | Sportpharm LLC | 85766-171 |