What is NDC 68071-1619?

68071-1619 is the product NDC for Amoxicillin and Clavulanate Potassium, Amoxicillin 400 mg/5mL; Clavulanic acid 57 mg/5mL powder, for suspension, listed with the FDA by NuCare Pharmaceuticals,Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

NuCare Pharmaceuticals,Inc., NDC labeler code 68071. 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 and Clavulanate Potassium?

200 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Amoxicillin and Clavulanate Potassium NDC 68071-1619

NDC codes

FDA NDC Directory

Product NDC (as listed)68071-1619Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68071-1619Add 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
68071-1619-1	6807116190168071161901	100 mL in 1 BOTTLE (68071-1619-1)Marketed from Nov 2, 2017

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 and Clavulanate Potassium
Generic name (nonproprietary): amoxicillin and clavulanate potassium
Active ingredients: Amoxicillin — 400 mg/5mLClavulanic acid — 57 mg/5mL
Dosage form: Powder, For suspension
Route: Oral
Labeler: NuCare Pharmaceuticals,Inc.NDC labeler code 68071
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 065191
Marketing start: Dec 1, 2007
Listing expires: Dec 31, 2026
Other FDA classes: Penicillins (Chemical structure)beta Lactamase Inhibitors (Mechanism)
Identifiers: Product ID 68071-1619_1d4c3bbf-43f9-8590-e063-6294a90adebbSPL ID 1d4c3bbf-43f9-8590-e063-6294a90adebbSPL set ID 5d074fe6-1ee0-40d8-e053-2a91aa0a7549RxCUI 617430UNII 804826J2HU, 23521W1S24UPC 0368071161915
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

N468071161901 followed by a unit qualifier and the quantity

Package 68071-1619-01. 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 Jul 15, 2024.

Indications (excerpt from the label)

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin and Clavulanate Potassium Powder for Oral Suspension, USP (amoxicillin/clavulanate potassium) and other antibacterial drugs, Amoxicillin and Clavulanate Potassium Powder 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 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68071-1619

What is NDC 68071-1619?: 68071-1619 is the product NDC for Amoxicillin and Clavulanate Potassium, Amoxicillin 400 mg/5mL; Clavulanic acid 57 mg/5mL powder, for suspension, listed with the FDA by NuCare Pharmaceuticals,Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Amoxicillin and Clavulanate Potassium.
What is the active ingredient?: Amoxicillin, Clavulanic acid.
Who is the labeler?: NuCare Pharmaceuticals,Inc., NDC labeler code 68071. 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 and Clavulanate Potassium?: 200 other product NDCs are listed under this name. See all Amoxicillin and Clavulanate Potassium 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 and Clavulanate Potassium NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Amoxicillin And Clavulanate Potassium	Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1	Tablet, CoatedOral	REMEDYREPACK INC.	70518-4758	70518-4758-00
Amoxicillin and Clavulanate Potassium	Amoxicillin 400 mg/5mL; Clavulanic acid 57 mg/5mL	Powder, For suspensionOral	Preferred Pharmaceuticals Inc.	68788-4179	68788-4179-01
Amoxicillin And Clavulanate Potassium	Amoxicillin 500 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0366	67046-0366-03
Amoxicillin and Clavulanate Potassium	Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0955	67046-0955-03
Amoxicillin and Clavulanate Potassium	Amoxicillin 562.5 mg/1 + 2 more ingredients	Tablet, Film coated, Extended releaseOral	USAntibiotics, LLC	81964-220	81964-0220-2881964-0220-40
Amoxicillin and Clavulanate Potassium	Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4424	70518-4424-00
Amoxicillin and Clavulanate Potassium	Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8836	68788-8836-02
Amoxicillin and Clavulanate Potassium	Amoxicillin 600 mg/5mL; Clavulanate potassium 42.9 mg/5mL	SuspensionOral	Preferred Pharmaceuticals Inc.	68788-8770	68788-8770-0168788-8770-07
Amoxicillin and Clavulanate Potassium	Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	Devatis, Inc.	73043-006	73043-0006-20
Amoxicillin and Clavulanate Potassium	Amoxicillin 500 mg/1; Clavulanate potassium 125 mg/1	Tablet, Film coatedOral	Devatis, Inc.	73043-007	73043-0007-20

All 201 Amoxicillin and Clavulanate Potassium NDCs

Other NDCs under ANDA 065191

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

FDA NDC Directory listings under ANDA 065191
Product	Strength	Form · route	Labeler	Product NDC
Amoxicillin and Clavulanate Potassium	Amoxicillin 200 mg/5mL; Clavulanic acid 28.5 mg/5mL	Powder, For suspensionOral	Hikma Pharmaceuticals USA Inc.	0143-9981
Amoxicillin and Clavulanate Potassium	Amoxicillin 400 mg/5mL; Clavulanic acid 57 mg/5mL	Powder, For suspensionOral	Hikma Pharmaceuticals USA Inc.	0143-9982
Amoxicillin and Clavulanate Potassium	Amoxicillin 400 mg/5mL; Clavulanic acid 57 mg/5mL	Powder, For suspensionOral	A-S Medication Solutions	50090-0928
Amoxicillin and Clavulanate Potassium	Amoxicillin 400 mg/5mL; Clavulanic acid 57 mg/5mL	Powder, For suspensionOral	Proficient Rx LP	63187-826
Amoxicillin and Clavulanate Potassium	Amoxicillin 400 mg/5mL; Clavulanic acid 57 mg/5mL	Powder, For suspensionOral	Preferred Pharmaceuticals Inc.	68788-4179