What is NDC 68071-5109?

68071-5109 is the product NDC for Amoxicillin, Amoxicillin 400 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?

274 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 68071-5109 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)68071-5109Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68071-5109Add 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
68071-5109-1	6807151090168071510901	100 mL in 1 BOTTLE (68071-5109-1)Marketed from Nov 18, 2019

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: 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 065334
Marketing start: Dec 28, 2006
Listing expires: Dec 31, 2026
Other FDA classes: Penicillins (Chemical structure)
Identifiers: Product ID 68071-5109_1b46d42b-ffdd-5da2-e063-6394a90afe28SPL ID 1b46d42b-ffdd-5da2-e063-6394a90afe28SPL set ID 97a657a3-8238-f5f1-e053-2a95a90a7a7aRxCUI 308189UNII 804826J2HUUPC 0368071510911
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

N468071510901 followed by a unit qualifier and the quantity

Package 68071-5109-01. 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 Jun 19, 2024.

Indications (excerpt from the label)

Amoxicillin for oral suspension is a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms. Infections of the ear, nose, throat, genitourinary tract, skin and skin structure, and lower respiratory tract. ( 1.1 - 1.4 ) In combination for treatment of H. pylori infection and duodenal ulcer disease. ( 1.5 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin for oral suspension and other antibacterial drugs, amoxicillin for oral suspension should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. ( 1.6 ) 1.1 Infections of the Ear, No…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68071-5109

What is NDC 68071-5109?: 68071-5109 is the product NDC for Amoxicillin, Amoxicillin 400 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.
What is the active ingredient?: Amoxicillin.
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?: 274 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 250 mg/1	CapsuleOral	Northwind Health Company, LLC	82868-088	82868-0088-30
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

All 275 Amoxicillin NDCs

Other NDCs under ANDA 065334

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

FDA NDC Directory listings under ANDA 065334
Product	Strength	Form · route	Labeler	Product NDC
Amoxicillin	Amoxicillin 400 mg/5mL	Powder, For suspensionOral	A-S Medication Solutions	50090-6323
Amoxicillin	Amoxicillin 400 mg/5mL	Powder, For suspensionOral	A-S Medication Solutions	50090-6355
Amoxicillin	Amoxicillin 400 mg/5mL	Powder, For suspensionOral	A-S Medication Solutions	50090-6680
Amoxicillin	Amoxicillin 200 mg/5mL	Powder, For suspensionOral	Rising Pharma Holdings, Inc.	57237-032
Amoxicillin	Amoxicillin 400 mg/5mL	Powder, For suspensionOral	Rising Pharma Holdings, Inc.	57237-033
Amoxicillin	Amoxicillin 400 mg/5mL	Powder, For suspensionOral	DIRECT RX	61919-401
Amoxicillin	Amoxicillin 400 mg/5mL	Powder, For suspensionOral	Proficient Rx LP	63187-262
Amoxicillin	Amoxicillin 400 mg/5mL	Powder, For suspensionOral	Proficient Rx LP	63187-335
Amoxicillin	Amoxicillin 200 mg/5mL	Powder, For suspensionOral	Aurobindo Pharma Limited	65862-070
Amoxicillin	Amoxicillin 400 mg/5mL	Powder, For suspensionOral	Aurobindo Pharma Limited	65862-071
Amoxicillin	Amoxicillin 200 mg/5mL	Powder, For suspensionOral	Preferred Pharmaceuticals Inc.	68788-8324
Amoxicillin	Amoxicillin 400 mg/5mL	Powder, For suspensionOral	Preferred Pharmaceuticals Inc.	68788-8325
Amoxicillin	Amoxicillin 400 mg/5mL	Powder, For suspensionOral	REMEDYREPACK INC.	70518-4522
Amoxicillin	Amoxicillin 200 mg/5mL	Powder, For suspensionOral	Proficient Rx LP	71205-775
Amoxicillin	Amoxicillin 400 mg/5mL	Powder, For suspensionOral	DirectRx	72189-285