NDC codes

FDA NDC Directory
Product NDC (as listed)63187-032Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63187-0032Add 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
63187-032-0663187003206631870032066 TABLET, FILM COATED in 1 BOTTLE (63187-032-06)Marketed from Dec 28, 2020
63187-032-20631870032206318700322020 TABLET, FILM COATED in 1 BOTTLE (63187-032-20)Marketed from May 1, 2014
63187-032-21631870032216318700322121 TABLET, FILM COATED in 1 BOTTLE (63187-032-21)Marketed from Dec 28, 2020

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

Generic name (nonproprietary)
amoxicillin and clavulanate potassium
Active ingredients
Amoxicillin — 500 mg/1Clavulanate potassium — 125 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Proficient Rx LPNDC labeler code 63187
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 065101
Marketing start
Listing expires
Other FDA classes
Penicillins (Chemical structure)beta Lactamase Inhibitors (Mechanism)
Identifiers
Product ID 63187-032_83901ad8-02a3-41a4-8c1d-cda4378c3b15SPL ID 83901ad8-02a3-41a4-8c1d-cda4378c3b15SPL set ID 482511ed-4531-45ec-a4eb-c600aeb03325RxCUI 562508, 617296UNII Q42OMW3AT8, 804826J2HUUPC 0363187327200, 0363187032203
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

N463187003206 followed by a unit qualifier and the quantity

Package 63187-0032-06. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin and Clavulanate Potassium Tablets USP, Amoxicillin and Clavulanate Potassium for Oral Suspension USP, and Amoxicillin and Clavulanate Potassium Tablets USP (Chewable) and other antibacterial drugs, Amoxicillin and Clavulanate Potassium Tablets USP, Amoxicillin and Clavulanate Potassium for Oral Suspension USP, and Amoxicillin and Clavulanate Potassium Tablets USP (Chewable) 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 modifyi…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63187-032

What is NDC 63187-032?
63187-032 is the product NDC for Amoxicillin and Clavulanate Potassium, Amoxicillin 500 mg/1; Clavulanate potassium 125 mg/1 tablet, film coated, 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?
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.

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

Other Amoxicillin and Clavulanate Potassium NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Amoxicillin And Clavulanate PotassiumAmoxicillin 875 mg/1; Clavulanate potassium 125 mg/1Tablet, CoatedOralREMEDYREPACK INC.70518-475870518-4758-00
Amoxicillin and Clavulanate PotassiumAmoxicillin 400 mg/5mL; Clavulanic acid 57 mg/5mLPowder, For suspensionOralPreferred Pharmaceuticals Inc.68788-417968788-4179-01
Amoxicillin And Clavulanate PotassiumAmoxicillin 500 mg/1; Clavulanate potassium 125 mg/1Tablet, Film coatedOralCoupler LLC67046-036667046-0366-03
Amoxicillin and Clavulanate PotassiumAmoxicillin 875 mg/1; Clavulanate potassium 125 mg/1Tablet, Film coatedOralCoupler LLC67046-095567046-0955-03
Amoxicillin and Clavulanate PotassiumAmoxicillin 562.5 mg/1 + 2 more ingredientsTablet, Film coated, Extended releaseOralUSAntibiotics, LLC81964-22081964-0220-2881964-0220-40
Amoxicillin and Clavulanate PotassiumAmoxicillin 875 mg/1; Clavulanate potassium 125 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-442470518-4424-00
Amoxicillin and Clavulanate PotassiumAmoxicillin 875 mg/1; Clavulanate potassium 125 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-883668788-8836-02
Amoxicillin and Clavulanate PotassiumAmoxicillin 600 mg/5mL; Clavulanate potassium 42.9 mg/5mLSuspensionOralPreferred Pharmaceuticals Inc.68788-877068788-8770-0168788-8770-07
Amoxicillin and Clavulanate PotassiumAmoxicillin 875 mg/1; Clavulanate potassium 125 mg/1Tablet, Film coatedOralDevatis, Inc.73043-00673043-0006-20
Amoxicillin and Clavulanate PotassiumAmoxicillin 500 mg/1; Clavulanate potassium 125 mg/1Tablet, Film coatedOralDevatis, Inc.73043-00773043-0007-20

All 201 Amoxicillin and Clavulanate Potassium NDCs

Other NDCs under ANDA 065101

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

FDA NDC Directory listings under ANDA 065101
ProductStrengthForm · routeLabelerProduct NDC
Amoxicillin and Clavulanate PotassiumAmoxicillin 500 mg/1; Clavulanate potassium 125 mg/1Tablet, Film coatedOralTeva Pharmaceuticals USA, Inc.0093-2274
Amoxicillin and Clavulanate PotassiumAmoxicillin 500 mg/1; Clavulanate potassium 125 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.55289-845
amoxicillin and clavulanate potassiumAmoxicillin 500 mg/1; Clavulanate potassium 125 mg/1TabletOralChartwell RX, LLC62135-091
Amoxicillin and Clavulanate PotassiumAmoxicillin 875 mg/1; Clavulanate potassium 125 mg/1Tablet, Film coatedOralProficient Rx LP63187-327
Amoxicillin and Clavulanate PotassiumAmoxicillin 500 mg/1; Clavulanate potassium 125 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.72789-418
Amoxicillin and Clavulanate PotassiumAmoxicillin 500 mg/1; Clavulanate potassium 125 mg/1Tablet, Film coatedOralAsclemed USA, Inc.76420-608

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