NDC codes

FDA NDC Directory
Product NDC (as listed)68071-3925Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68071-3925Add 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
68071-3925-168071392501100 mL in 1 BOTTLE (68071-3925-1)Marketed from Dec 4, 2025

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 — 400 mg/5mL
Dosage form
For suspension
Route
Oral
Product type
Prescription drug
Marketing category
NDA authorized genericApplication NDA 050760
Marketing start
Listing expires
Other FDA classes
Penicillins (Chemical structure)
Identifiers
Product ID 68071-3925_4528faa7-3b08-a65e-e063-6394a90aa52cSPL ID 4528faa7-3b08-a65e-e063-6394a90aa52cSPL set ID 4528f48d-5bda-b307-e063-6294a90a294cRxCUI 308189UNII 804826J2HUUPC 0368071392517

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

N468071392501 followed by a unit qualifier and the quantity

Package 68071-3925-01. 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)

1. INDICATIONS AND USAGE Adults and Pediatric Patients Upper Respiratory Tract Infections of the Ear, Nose, and Throat: Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus species. (α-and ​ ​ β-hemolytic isolates only), Streptococcus pneumoniae , Staphylococcus spp., or Haemophilus influenzae . Infections of the Genitourinary Tract : Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Escherichia coli, Proteus mirabilis , or Enterococcus faecalis . Infections of the Skin and Skin Structure: Amoxicillin is indicated in the treatment of infections due to s…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 050760

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

FDA NDC Directory listings under NDA 050760
ProductStrengthForm · routeLabelerProduct NDC
AmoxicillinAmoxicillin 400 mg/5mLFor suspensionOralREMEDYREPACK INC.70518-4529
AmoxicillinAmoxicillin 400 mg/5mLFor suspensionOralASCLEMED USA INC.87063-058
AmoxicillinAmoxicillin 400 mg/5mLFor suspensionOralUSAntibiotics, LLC81964-207

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