What is NDC 70518-4424?

70518-4424 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 1 package NDC, shown above in 10- and 11-digit form.

What is the active ingredient?

Amoxicillin, Clavulanate potassium.

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?

201 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Amoxicillin and Clavulanate Potassium NDC 70518-4424

NDC codes

FDA NDC Directory

Product NDC (as listed)70518-4424Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70518-4424Add 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 NDC	11-digit (billing)	Package	Copy
70518-4424-0	70518442400	30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4424-0)Marketed from Aug 5, 2025

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 091568
Marketing start: Aug 5, 2025
Listing expires: Dec 31, 2027
Other FDA classes: Penicillins (Chemical structure)beta Lactamase Inhibitors (Mechanism)
Identifiers: Product ID 70518-4424_5b25384d-91b5-5c37-e063-6394a90a9064SPL ID 5b25384d-91b5-5c37-e063-6394a90a9064SPL set ID 704e99b1-c14a-40bf-adbd-c2794fa92c72RxCUI 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

N470518442400 followed by a unit qualifier and the quantity

Package 70518-4424-00. 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 Sep 10, 2026.

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 Klebsiella speci…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70518-4424

What is NDC 70518-4424?: 70518-4424 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 1 package NDC, 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?: 201 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Amoxicillin and Clavulanate Potassium NDCs
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	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
Amoxicillin and Clavulanate Potassium	Amoxicillin 600 mg/5mL; Clavulanate potassium 42.9 mg/5mL	Powder, For suspensionOral	Devatis Inc.	73043-008	73043-0008-0173043-0008-0273043-0008-03

All 202 Amoxicillin and Clavulanate Potassium NDCs

Other NDCs under ANDA 091568

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

FDA NDC Directory listings under ANDA 091568
Product	Strength	Form · route	Labeler	Product NDC
Amoxicillin and Clavulanate Potassium	Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	NorthStar Rx LLC	16714-297
Amoxicillin and Clavulanate Potassium	Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-0822
Amoxicillin and Clavulanate Potassium	Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-1809
Amoxicillin and Clavulanate Potassium	Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-4413
Amoxicillin and Clavulanate Potassium	Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-7003
Amoxicillin and Clavulanate Potassium	Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	American Health Packaging	60687-803
Amoxicillin and Clavulanate Potassium	Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	Proficient Rx LP	63187-014
Amoxicillin and Clavulanate Potassium	Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	63629-4541
Amoxicillin and Clavulanate Potassium	Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	63629-5847
Amoxicillin and Clavulanate Potassium	Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	65862-503
Amoxicillin and Clavulanate Potassium	Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0955
Amoxicillin and Clavulanate Potassium	Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	NuCare Pharmaceutials,Inc.	68071-2751
Amoxicillin and Clavulanate Potassium	Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals, Inc.	68071-3860
Amoxicillin and Clavulanate Potassium	Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-3864
Amoxicillin and Clavulanate Potassium	Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-4586
Amoxicillin and Clavulanate Potassium	Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals, Inc.	68071-5295
Amoxicillin and Clavulanate Potassium	Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8836
Amoxicillin and Clavulanate Potassium	Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-2225
Amoxicillin and Clavulanate Potassium	Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-3676
Amoxicillin and Clavulanate Potassium	Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-2787

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