What is NDC 65862-016?

65862-016 is the product NDC for Amoxicillin, Amoxicillin 250 mg/1 capsule, listed with the FDA by Aurobindo Pharma Limited. It has 5 package NDCs, shown above in 10- and 11-digit form.

Aurobindo Pharma Limited, NDC labeler code 65862. 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 65862-016 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)65862-016Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65862-0016Add 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
65862-016-01	6586200160165862001601	100 CAPSULE in 1 BOTTLE (65862-016-01)Marketed from Nov 9, 2005
65862-016-05	6586200160565862001605	500 CAPSULE in 1 BOTTLE (65862-016-05)Marketed from Nov 9, 2005
65862-016-20	6586200162065862001620	20 CAPSULE in 1 BOTTLE (65862-016-20)Marketed from Nov 9, 2005
65862-016-30	6586200163065862001630	30 CAPSULE in 1 BOTTLE (65862-016-30)Marketed from Nov 9, 2005
65862-016-50	6586200165065862001650	50 CAPSULE in 1 BOTTLE (65862-016-50)Marketed from Nov 9, 2005

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 — 250 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Aurobindo Pharma LimitedNDC labeler code 65862
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 065271
Marketing start: Nov 9, 2005
Listing expires: Dec 31, 2026
Other FDA classes: Penicillins (Chemical structure)
Identifiers: Product ID 65862-016_4dc94f3c-990d-476f-a88e-df9967570eecSPL ID 4dc94f3c-990d-476f-a88e-df9967570eecSPL set ID 7e3a4517-1934-4e03-b96b-4ad65ab076c5RxCUI 308182, 308191UNII 804826J2HUUPC 0365862017208, 0365862016201
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

N465862001601 followed by a unit qualifier and the quantity

Package 65862-0016-01. 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 Jan 23, 2024.

Indications (excerpt from the label)

Adults and Pediatric Patients Upper Respiratory Tract Infections of the Ear, Nose, and Throat: Amoxicillin capsules are 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 capsules are 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 capsules are indicated in the treatment of infections due to…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 65862-016

What is NDC 65862-016?: 65862-016 is the product NDC for Amoxicillin, Amoxicillin 250 mg/1 capsule, listed with the FDA by Aurobindo Pharma Limited. It has 5 package NDCs, 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?: Aurobindo Pharma Limited, NDC labeler code 65862. 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 065271

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

FDA NDC Directory listings under ANDA 065271
Product	Strength	Form · route	Labeler	Product NDC
Amoxicillin	Amoxicillin 500 mg/1	CapsuleOral	NuCare Pharmaceuticals,Inc.	68071-4907
Amoxicillin	Amoxicillin 500 mg/1	CapsuleOral	PD-Rx Pharmaceuticals, Inc.	43063-820
Amoxicillin	Amoxicillin 500 mg/1	CapsuleOral	Aurobindo Pharma Limited	65862-017
Amoxicillin	Amoxicillin 500 mg/1	CapsuleOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0269
Amoxicillin	Amoxicillin 500 mg/1	CapsuleOral	A-S Medication Solutions	50090-1512
Amoxicillin	Amoxicillin 500 mg/1	CapsuleOral	Bryant Ranch Prepack	63629-7584
Amoxicillin	Amoxicillin 500 mg/1	CapsuleOral	A-S Medication Solutions	50090-1511
Amoxicillin	Amoxicillin 500 mg/1	CapsuleOral	A-S Medication Solutions	50090-1513
Amoxicillin	Amoxicillin 500 mg/1	CapsuleOral	A-S Medication Solutions	50090-1514
Amoxicillin	Amoxicillin 500 mg/1	CapsuleOral	NuCare Pharmaceuticals,Inc.	68071-4920
Amoxicillin	Amoxicillin 500 mg/1	CapsuleOral	NuCare Pharmaceuticals,Inc.	68071-3517
Amoxicillin	Amoxicillin 250 mg/1	CapsuleOral	Redpharm Drug	67296-2295
Amoxicillin	Amoxicillin 500 mg/1	CapsuleOral	Redpharm Drug	67296-2292
Amoxicillin	Amoxicillin 500 mg/1	CapsuleOral	Coupler LLC	67046-1175
Amoxicillin	Amoxicillin 250 mg/1	CapsuleOral	NuCare Pharmaceuticals,Inc.	68071-4953
Amoxicillin	Amoxicillin 500 mg/1	CapsuleOral	Asclemed USA, Inc.	76420-508
Amoxicillin	Amoxicillin 250 mg/1	CapsuleOral	American Health Packaging	60687-776
Amoxicillin	Amoxicillin 250 mg/1	CapsuleOral	Asclemed USA, Inc.	76420-832
Amoxicillin	Amoxicillin 500 mg/1	CapsuleOral	Northwind Health Company, LLC	82868-056
Amoxicillin	Amoxicillin 500 mg/1	CapsuleOral	American Health Packaging	60687-787

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