What is NDC 63187-857?

63187-857 is the product NDC for Amoxicillin and Clavulanate Potassium, Amoxicillin 600 mg/5mL; Clavulanate potassium 42.9 mg/5mL powder, for suspension, listed with the FDA by Proficient Rx LP. It has 3 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Amoxicillin, Clavulanate potassium.

Proficient Rx LP, NDC labeler code 63187. 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 63187-857

NDC codes

FDA NDC Directory

Product NDC (as listed)63187-857Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63187-0857Add 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
63187-857-12	63187085712	125 mL in 1 BOTTLE (63187-857-12)Marketed from Jun 1, 2017
63187-857-20	63187085720	200 mL in 1 BOTTLE (63187-857-20)Marketed from Nov 1, 2018
63187-857-75	63187085775	75 mL in 1 BOTTLE (63187-857-75)Marketed from Sep 1, 2019

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 — 600 mg/5mLClavulanate potassium — 42.9 mg/5mL
Dosage form: Powder, For suspension
Route: Oral
Labeler: Proficient Rx LPNDC labeler code 63187
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 065162
Marketing start: Sep 23, 2004
Listing expires: Dec 31, 2026
Other FDA classes: Penicillins (Chemical structure)beta Lactamase Inhibitors (Mechanism)
Identifiers: Product ID 63187-857_665eb028-198a-4309-97c8-e4f97f1b7bbaSPL ID 665eb028-198a-4309-97c8-e4f97f1b7bbaSPL set ID 3a7248ca-2855-433e-aabc-42f0bb0db118RxCUI 617993UNII 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

N463187085712 followed by a unit qualifier and the quantity

Package 63187-0857-12. 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 Jun 1, 2022.

Indications (excerpt from the label)

To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium for oral suspension USP and other antibacterial drugs, amoxicillin and clavulanate potassium for oral suspension USP should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Amoxicillin and clavulanate potassium for oral suspension USP, 600 mg/42.9 mg pe…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63187-857

What is NDC 63187-857?: 63187-857 is the product NDC for Amoxicillin and Clavulanate Potassium, Amoxicillin 600 mg/5mL; Clavulanate potassium 42.9 mg/5mL powder, for suspension, listed with the FDA by Proficient Rx LP. 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?: Proficient Rx LP, NDC labeler code 63187. 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	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 500 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	Devatis, Inc.	73043-007	73043-0007-20
Amoxicillin and Clavulanate Potassium	Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	Devatis, Inc.	73043-006	73043-0006-20

All 202 Amoxicillin and Clavulanate Potassium NDCs

Other NDCs under ANDA 065162

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

FDA NDC Directory listings under ANDA 065162
Product	Strength	Form · route	Labeler	Product NDC
amoxicillin and clavulanate potassium	Amoxicillin 600 mg/5mL; Clavulanate potassium 42.9 mg/5mL	Powder, For suspensionOral	Chartwell RX, LLC	62135-095
Amoxicillin and Clavulanate Potassium	Amoxicillin 600 mg/5mL; Clavulanate potassium 42.9 mg/5mL	Powder, For suspensionOral	Teva Pharmaceuticals USA, Inc.	0093-8675