NDC codes

FDA NDC Directory
Product NDC (as listed)70518-2263Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70518-2263Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
70518-2263-07051822630030 TABLET, FILM COATED in 1 BLISTER PACK (70518-2263-0)Marketed from Aug 12, 2019
70518-2263-17051822630120 TABLET, FILM COATED in 1 BLISTER PACK (70518-2263-1)Marketed from Aug 12, 2019
70518-2263-27051822630214 TABLET, FILM COATED in 1 BLISTER PACK (70518-2263-2)Marketed from Dec 12, 2019
70518-2263-370518226303100 POUCH in 1 BOX (70518-2263-3) / 1 TABLET, FILM COATED in 1 POUCH (70518-2263-4)Marketed from Nov 17, 2021
70518-2263-77051822630730 TABLET, FILM COATED in 1 BLISTER PACK (70518-2263-7)Marketed from Sep 14, 2022
70518-2263-87051822630820 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-2263-8)Marketed from Mar 14, 2023
70518-2263-97051822630914 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
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

N470518226300 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 204755

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 204755
ProductStrengthForm · routeLabelerProduct NDC
Amoxicillin and Clavulanate PotassiumClavulanate potassium 125 mg/1; Amoxicillin 875 mg/1Tablet, Film coatedOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0180
Amoxicillin And Clavulanate PotassiumAmoxicillin 875 mg/1; Clavulanate potassium 125 mg/1Tablet, Film coatedOralProficient Rx LP71205-331
Amoxicillin And Clavulanate PotassiumAmoxicillin 875 mg/1; Clavulanate potassium 125 mg/1Tablet, Film coatedOralMedsource Pharmaceuticals45865-227
Amoxicillin And Clavulanate PotassiumAmoxicillin 875 mg/1; Clavulanate potassium 125 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC82868-002
Amoxicillin And Clavulanate PotassiumAmoxicillin 875 mg/1; Clavulanate potassium 125 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2917
Amoxicillin And Clavulanate PotassiumAmoxicillin 875 mg/1; Clavulanate potassium 125 mg/1Tablet, Film coatedOralAsclemed USA, Inc.76420-005
Amoxicillin And Clavulanate PotassiumAmoxicillin 875 mg/1; Clavulanate potassium 125 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-7531
Amoxicillin And Clavulanate PotassiumAmoxicillin 875 mg/1; Clavulanate potassium 125 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-3967
Amoxicillin And Clavulanate PotassiumAmoxicillin 875 mg/1; Clavulanate potassium 125 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-3402
Amoxicillin And Clavulanate PotassiumAmoxicillin 875 mg/1; Clavulanate potassium 125 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-4549
Amoxicillin And Clavulanate PotassiumAmoxicillin 875 mg/1; Clavulanate potassium 125 mg/1Tablet, Film coatedOralMicro Labs Limited42571-162
Amoxicillin And Clavulanate PotassiumAmoxicillin 875 mg/1; Clavulanate potassium 125 mg/1Tablet, Film coatedOralSportpharm LLC85766-171
Amoxicillin And Clavulanate PotassiumAmoxicillin 875 mg/1; Clavulanate potassium 125 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-4224
Amoxicillin And Clavulanate PotassiumAmoxicillin 875 mg/1; Clavulanate potassium 125 mg/1Tablet, Film coatedOralBryant Ranch Prepack72162-2434

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