Amoxicillin NDC 0781-5061

NDC codes

FDA NDC Directory

Product NDC (as listed)0781-5061Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00781-5061Add 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 NDC	11-digit (billing)	Package	Copy
0781-5061-01	00781506101	100 TABLET, FILM COATED in 1 BOTTLE (0781-5061-01)Marketed from Jul 13, 2005
0781-5061-20	00781506120	20 TABLET, FILM COATED in 1 BOTTLE (0781-5061-20)Marketed from Jul 13, 2005

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
Generic name (nonproprietary): amoxicillin
Active ingredients: Amoxicillin — 875 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Sandoz Inc
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 065228
Marketing start: Jul 13, 2005
Listing expires: Dec 31, 2027
Other FDA classes: Penicillins (Chemical structure)
Identifiers: Product ID 0781-5061_f4681ad2-fcc2-41f6-9100-90fb4524cd28SPL ID f4681ad2-fcc2-41f6-9100-90fb4524cd28SPL set ID 13bd4214-9b7f-425b-af5f-fc1ddc678230RxCUI 239191, 308182, 308189, 308191, 308192, 308194, 313797, 313850UNII 804826J2HUUPC 0307816156526, 0307812020012, 0307816041587, 0307815060015, 0307815061012, 0307816157523, 0307816039584, 0307812613016
Pharmacologic class: Penicillin-class Antibacterial

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

N400781506101 followed by a unit qualifier and the quantity

Package 00781-5061-01. 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 Feb 22, 2024.

Indications (excerpt from the label)

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 susceptible (ONLY β-lactamase…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 065228

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

FDA NDC Directory listings under ANDA 065228
Product	Strength	Form · route	Labeler	Product NDC
Amoxicillin	Amoxicillin 875 mg/1	Tablet, Film coatedOral	Proficient Rx LP	71205-035
Amoxicillin	Amoxicillin 875 mg/1	Tablet, Film coatedOral	Direct_Rx	72189-463
Amoxicillin	Amoxicillin 500 mg/1	Tablet, Film coatedOral	Sandoz Inc	0781-5060
Amoxicillin	Amoxicillin 875 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-4152