What is NDC 72189-367?

72189-367 is the product NDC for Amoxicillin/Clav Pot Oral Susp, Amoxicillin 400 mg/5mL; Clavulanate potassium 57 mg/5mL powder, for suspension, listed with the FDA by Direct_Rx. It has 1 package NDC, shown above in 10- and 11-digit form.

What is the active ingredient?

Amoxicillin, Clavulanate potassium.

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/Clav Pot Oral Susp?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Amoxicillin/Clav Pot Oral Susp NDC 72189-367

NDC codes

FDA NDC Directory

Product NDC (as listed)72189-367Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72189-0367Add 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
72189-367-32	7218903673272189036732	5 mL in 1 BOTTLE (72189-367-32)Marketed from Aug 8, 2022

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/Clav Pot Oral Susp
Generic name (nonproprietary): amoxicillin/clav pot oral susp
Active ingredients: Amoxicillin — 400 mg/5mLClavulanate potassium — 57 mg/5mL
Dosage form: Powder, For suspension
Route: Oral
Labeler: Direct_RxNDC labeler code 72189
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 201090
Marketing start: Aug 8, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Penicillins (Chemical structure)beta Lactamase Inhibitors (Mechanism)
Identifiers: Product ID 72189-367_2c4c9fa2-4c33-c1f5-e063-6294a90a4706SPL ID 2c4c9fa2-4c33-c1f5-e063-6294a90a4706SPL set ID e5bd9918-b073-c50b-e053-2a95a90aaeb7RxCUI 617430UNII 804826J2HU, Q42OMW3AT8
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

N472189036732 followed by a unit qualifier and the quantity

Package 72189-0367-32. 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)

To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium for oral suspension, USP and other antibacterial drugs, amoxicillin and clavulanate potassium for oral suspension, USP should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Amoxicillin and clavulanate potassium for oral suspension, USP is a combinatio…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72189-367

What is NDC 72189-367?: 72189-367 is the product NDC for Amoxicillin/Clav Pot Oral Susp, Amoxicillin 400 mg/5mL; Clavulanate potassium 57 mg/5mL powder, for suspension, 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/Clav Pot Oral Susp.
What is the active ingredient?: Amoxicillin, Clavulanate potassium.
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/Clav Pot Oral Susp?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under ANDA 201090

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

FDA NDC Directory listings under ANDA 201090
Product	Strength	Form · route	Labeler	Product NDC
Amoxicillin and Clavulanate Potassium	Amoxicillin 200 mg/5mL; Clavulanate potassium 28.5 mg/5mL	Powder, For suspensionOral	Preferred Pharmaceuticals Inc.	68788-8306
Amoxicillin and Clavulanate Potassium	Amoxicillin 400 mg/5mL; Clavulanate potassium 57 mg/5mL	Powder, For suspensionOral	Preferred Pharmaceuticals Inc.	68788-8318
Amoxicillin and Clavulanate Potassium	Amoxicillin 200 mg/5mL; Clavulanate potassium 28.5 mg/5mL	Powder, For suspensionOral	A-S Medication Solutions	50090-6222
Amoxicillin and Clavulanate Potassium	Amoxicillin 200 mg/5mL; Clavulanate potassium 28.5 mg/5mL	Powder, For suspensionOral	Aurobindo Pharma Limited	65862-533
Amoxicillin and Clavulanate Potassium	Amoxicillin 400 mg/5mL; Clavulanate potassium 57 mg/5mL	Powder, For suspensionOral	Aurobindo Pharma Limited	65862-534
Amoxicillin and Clavulanate Potassium	Amoxicillin 400 mg/5mL; Clavulanate potassium 57 mg/5mL	Powder, For suspensionOral	NuCare Pharmaceuticals,Inc.	68071-2518
Amoxicillin and Clavulanate Potassium	Amoxicillin 400 mg/5mL; Clavulanate potassium 57 mg/5mL	Powder, For suspensionOral	A-S Medication Solutions	50090-6694
Amoxicillin and Clavulanate Potassium	Amoxicillin 400 mg/5mL; Clavulanate potassium 57 mg/5mL	Powder, For suspensionOral	A-S Medication Solutions	50090-5873
Amoxicillin and Clavulanate Potassium	Amoxicillin 200 mg/5mL; Clavulanate potassium 28.5 mg/5mL	Powder, For suspensionOral	NuCare Pharmaceuticals, Inc.	68071-3807
Amoxicillin and Clavulanate Potassium	Amoxicillin 200 mg/5mL; Clavulanate potassium 28.5 mg/5mL	Powder, For suspensionOral	A-S Medication Solutions	50090-5932
Amoxicillin and Clavulanate Potassium	Amoxicillin 200 mg/5mL; Clavulanate potassium 28.5 mg/5mL	Powder, For suspensionOral	Asclemed USA, Inc.	76420-859
Amoxicillin and Clavulanate Potassium	Amoxicillin 400 mg/5mL; Clavulanate potassium 57 mg/5mL	Powder, For suspensionOral	Asclemed USA, Inc.	76420-864
Amoxicillin and Clavulanate Potassium	Amoxicillin 400 mg/5mL; Clavulanate potassium 57 mg/5mL	Powder, For suspensionOral	HAWAII REPACK, INC.	85534-0041
Amoxicillin and Clavulanate Potassium	Amoxicillin 400 mg/5mL; Clavulanate potassium 57 mg/5mL	Powder, For suspensionOral	A-S Medication Solutions	50090-3309
Amoxicillin and Clavulanate Potassium	Amoxicillin 400 mg/5mL; Clavulanate potassium 57 mg/5mL	Powder, For suspensionOral	Proficient Rx LP	71205-462
Amoxicillin and Clavulanate Potassium	Amoxicillin 200 mg/5mL; Clavulanate potassium 28.5 mg/5mL	Powder, For suspensionOral	NorthStar Rx LLC	16714-292
Amoxicillin and Clavulanate Potassium	Amoxicillin 400 mg/5mL; Clavulanate potassium 57 mg/5mL	Powder, For suspensionOral	NorthStar Rx LLC	16714-293
Amoxicillin and Clavulanate Potassium	Amoxicillin 200 mg/5mL; Clavulanate potassium 28.5 mg/5mL	Powder, For suspensionOral	HAWAII REPACK, INC.	85534-0080
Amoxicillin and Clavulanate Potassium	Amoxicillin 400 mg/5mL; Clavulanate potassium 57 mg/5mL	Powder, For suspensionOral	NuCare Pharmaceuticals,Inc.	68071-2227