What is NDC 72189-463?

72189-463 is the product NDC for Amoxicillin, Amoxicillin 875 mg/1 tablet, film coated, listed with the FDA by Direct_Rx. It has 1 package NDC, shown above in 10- and 11-digit form.

Direct_Rx, NDC labeler code 72189. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Amoxicillin?

270 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Amoxicillin NDC 72189-463 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)72189-463Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72189-0463Add 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
72189-463-20	72189046320	20 TABLET, FILM COATED in 1 BOTTLE (72189-463-20)Marketed from Apr 17, 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): Amoxicillin
Generic name (nonproprietary): amoxicillin
Active ingredients: Amoxicillin — 875 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Direct_RxNDC labeler code 72189
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 065228
Marketing start: Apr 17, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Penicillins (Chemical structure)
Identifiers: Product ID 72189-463_2c4de9c8-898d-f59d-e063-6294a90afdc1SPL ID 2c4de9c8-898d-f59d-e063-6294a90afdc1SPL set ID f98c49a3-e6bb-7fc7-e053-6394a90a9062RxCUI 308194UNII 804826J2HU
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

N472189046320 followed by a unit qualifier and the quantity

Package 72189-0463-20. 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 Jan 22, 2025.

Indications (excerpt from the label)

1.1 Infections of the Ear, Nose, and Throat Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY beta-lactamase–negative) isolates of Streptococcus species. (α- and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae. 1.2 Infections of the Genitourinary Tract Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY beta-lactamase–negative) isolates of Escherichia coli, Proteus mirabilis, or Enterococcus faecalis. 1.3 Infections of the Skin and Skin Structure Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY beta-lactamase–negative) isolates of Streptococcus spp.…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72189-463

What is NDC 72189-463?: 72189-463 is the product NDC for Amoxicillin, Amoxicillin 875 mg/1 tablet, film coated, listed with the FDA by Direct_Rx. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Amoxicillin.
What is the active ingredient?: Amoxicillin.
Who is the labeler?: Direct_Rx, NDC labeler code 72189. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Amoxicillin?: 270 other product NDCs are listed under this name. See all Amoxicillin NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Amoxicillin NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Amoxicillin	Amoxicillin 875 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0734	67046-0734-03
Amoxicillin	Amoxicillin 875 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-4152	68788-4152-02
Amoxicillin	Amoxicillin 500 mg/1	CapsuleOral	Coupler LLC	67046-0316	67046-0316-03
Amoxicillin	Amoxicillin 250 mg/1	CapsuleOral	Coupler LLC	67046-0127	67046-0127-03
Amoxicillin	Amoxicillin 875 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0015	67046-0015-03
Amoxicillin	Amoxicillin 500 mg/1	CapsuleOral	Coupler LLC	67046-1175	67046-1175-03
Amoxicillin	Amoxicillin 875 mg/1	Tablet, CoatedOral	Preferred Pharmaceuticals Inc.	68788-4062	68788-4062-02
Amoxicillin	Amoxicillin 400 mg/5mL	For suspensionOral	REMEDYREPACK INC.	70518-4529	70518-4529-00
Amoxicillin	Amoxicillin 400 mg/5mL	Powder, For suspensionOral	REMEDYREPACK INC.	70518-4522	70518-4522-00
Amoxicillin	Amoxicillin 400 mg/5mL	Powder, For suspensionOral	REMEDYREPACK INC.	70518-4521	70518-4521-00

All 271 Amoxicillin NDCs

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	Preferred Pharmaceuticals Inc.	68788-4152
Amoxicillin	Amoxicillin 875 mg/1	Tablet, Film coatedOral	Proficient Rx LP	71205-035
Amoxicillin	Amoxicillin 500 mg/1	Tablet, Film coatedOral	Sandoz Inc	0781-5060
Amoxicillin	Amoxicillin 875 mg/1	Tablet, Film coatedOral	Sandoz Inc	0781-5061