NDC codes

FDA NDC Directory
Product NDC (as listed)71205-331Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71205-0331Add 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
71205-331-147120503311414 TABLET, FILM COATED in 1 BOTTLE (71205-331-14)Marketed from May 5, 2020
71205-331-157120503311515 TABLET, FILM COATED in 1 BOTTLE (71205-331-15)Marketed from Oct 1, 2019
71205-331-207120503312020 TABLET, FILM COATED in 1 BOTTLE (71205-331-20)Marketed from Oct 1, 2019
71205-331-307120503313030 TABLET, FILM COATED in 1 BOTTLE (71205-331-30)Marketed from Oct 1, 2019
71205-331-607120503316060 TABLET, FILM COATED in 1 BOTTLE (71205-331-60)Marketed from Oct 1, 2019
71205-331-907120503319090 TABLET, FILM COATED in 1 BOTTLE (71205-331-90)Marketed from Oct 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 — 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 71205-331_27878fe9-95a7-48a5-9819-5cf994a8e3c8SPL ID 27878fe9-95a7-48a5-9819-5cf994a8e3c8SPL set ID e08c1bee-14c8-4bd1-898c-1874251dadf8RxCUI 562508UNII 804826J2HU, Q42OMW3AT8UPC 0371205331146
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

N471205033114 followed by a unit qualifier and the quantity

Package 71205-0331-14. 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)

To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium tablets USP, and other antibacterial drugs, amoxicillin and clavulanate potassium 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 tablets USP is a combination penicillin-class antibacterial and beta-lactamas…

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 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 coatedOralREMEDYREPACK INC.70518-2263
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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