NDC codes

FDA NDC Directory
Product NDC (as listed)71297-240Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71297-0240Add 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
71297-240-347129702403475 mL in 1 BOTTLE (71297-240-34)Marketed from Feb 20, 2024
71297-240-3571297024035100 mL in 1 BOTTLE (71297-240-35)Marketed from Sep 1, 2023
71297-240-3671297024036150 mL in 1 BOTTLE (71297-240-36)Marketed from Sep 1, 2023

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)
Augmentin
Generic name (nonproprietary)
amoxicillin and clavulanate potassium
Active ingredients
Amoxicillin125 mg/5mLClavulanate potassium31.25 mg/5mL
Dosage form
For suspension
Route
Oral
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 050575
Marketing start
Listing expires
Other FDA classes
Penicillins (Chemical structure)beta Lactamase Inhibitors (Mechanism)
Identifiers
Product ID 71297-240_18975386-c292-a0cb-e063-6294a90aed18SPL ID 18975386-c292-a0cb-e063-6294a90aed18SPL set ID 04a31a42-d79e-bbb4-e063-6394a90a63eeRxCUI 617302, 617333UNII 804826J2HU, Q42OMW3AT8UPC 0371297240364, 0371297240340
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

N471297024034 followed by a unit qualifier and the quantity

Package 71297-0240-34. 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)

AUGMENTIN is 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 species. Urinary Tract Infections - caus

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 050575

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

FDA NDC Directory listings under NDA 050575
ProductStrengthForm · routeLabelerProduct NDC
Amoxicillin And Clavulanate PotassiumAmoxicillin 250 mg/5mL; Clavulanate potassium 62.5 mg/5mLFor suspensionOralUSAntibiotics, LLC81964-204
Amoxicillin And Clavulanate PotassiumAmoxicillin 125 mg/5mL; Clavulanate potassium 31.25 mg/5mLFor suspensionOralUSAntibiotics, LLC81964-212

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