NDC codes

FDA NDC Directory
Product NDC (as listed)68071-2558Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68071-2558Add 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
68071-2558-568071255805150 mL in 1 BOTTLE (68071-2558-5)Marketed from Oct 28, 2021

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
Generic name (nonproprietary)
amoxicillin
Active ingredients
Amoxicillin — 250 mg/5mL
Dosage form
Powder, For suspension
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 061931
Marketing start
Listing expires
Other FDA classes
Penicillins (Chemical structure)
Identifiers
Product ID 68071-2558_2dcc5889-6ad9-d3dc-e063-6294a90a50f7SPL ID 2dcc5889-6ad9-d3dc-e063-6294a90a50f7SPL set ID cf707c13-3b40-079c-e053-2995a90a2176RxCUI 239191UNII 804826J2HUUPC 0368071255850

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

N468071255805 followed by a unit qualifier and the quantity

Package 68071-2558-05. 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)

Amoxicillin is a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms. Infections of the ear, nose, throat, genitourinary tract, skin and skin structure, and lower respiratory tract. ( 1.1 to 1.4 ) In combination for treatment of H. pylori infection and duodenal ulcer disease. ( 1.5 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin capsules, amoxicillin for oral suspension, amoxicillin tablets (chewable) and other antibacterial drugs, amoxicillin capsules, amoxicillin for oral suspension, and amoxicillin tablets (chewable) should be used only to treat infections that are…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 061931

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

FDA NDC Directory listings under ANDA 061931
ProductStrengthForm · routeLabelerProduct NDC
AmoxicillinAmoxicillin 250 mg/5mLPowder, For suspensionOralNuCare Pharmaceuticals,Inc.66267-994
AmoxicillinAmoxicillin 250 mg/5mLPowder, For suspensionOralChartwell RX, LLC62135-089
AmoxicillinAmoxicillin 125 mg/5mLPowder, For suspensionOralChartwell RX, LLC62135-109
AmoxicillinAmoxicillin 250 mg/5mLPowder, For suspensionOralAsclemed USA, Inc.76420-573
AmoxicillinAmoxicillin 250 mg/5mLPowder, For suspensionOralProficient Rx LP63187-186
AmoxicillinAmoxicillin 250 mg/5mLPowder, For suspensionOralTeva Pharmaceuticals USA, Inc.0093-4155

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