NDC codes

FDA NDC Directory
Product NDC (as listed)65862-015Labeler and product segments. Claims need a package NDC.
Product NDC at billing width65862-0015Add 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 NDC11-digit (billing)PackageCopy
65862-015-016586200150165862001501100 TABLET, FILM COATED in 1 BOTTLE (65862-015-01)Marketed from Nov 9, 2005
65862-015-056586200150565862001505500 TABLET, FILM COATED in 1 BOTTLE (65862-015-05)Marketed from Nov 9, 2005
65862-015-20658620015206586200152020 TABLET, FILM COATED in 1 BOTTLE (65862-015-20)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 — 875 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Aurobindo Pharma LimitedNDC labeler code 65862
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 065256
Marketing start
Listing expires
Other FDA classes
Penicillins (Chemical structure)
Identifiers
Product ID 65862-015_ee0e12cd-e881-4048-a0fb-74bd771cb9aaSPL ID ee0e12cd-e881-4048-a0fb-74bd771cb9aaSPL set ID 99103779-6d2f-4e4b-9b7f-0b24d7c6bf4eRxCUI 308192, 308194UNII 804826J2HUUPC 0365862015013

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

N465862001501 followed by a unit qualifier and the quantity

Package 65862-0015-01. 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 .

Indications (excerpt from the label)

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

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 65862-015

What is NDC 65862-015?
65862-015 is the product NDC for Amoxicillin, Amoxicillin 875 mg/1 tablet, film coated, listed with the FDA by Aurobindo Pharma Limited. It has 3 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
AmoxicillinAmoxicillin 250 mg/1CapsuleOralNorthwind Health Company, LLC82868-08882868-0088-30
AmoxicillinAmoxicillin 875 mg/1Tablet, Film coatedOralCoupler LLC67046-073467046-0734-03
AmoxicillinAmoxicillin 875 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-415268788-4152-02
AmoxicillinAmoxicillin 500 mg/1CapsuleOralCoupler LLC67046-031667046-0316-03
AmoxicillinAmoxicillin 250 mg/1CapsuleOralCoupler LLC67046-012767046-0127-03
AmoxicillinAmoxicillin 875 mg/1Tablet, Film coatedOralCoupler LLC67046-001567046-0015-03
AmoxicillinAmoxicillin 500 mg/1CapsuleOralCoupler LLC67046-117567046-1175-03
AmoxicillinAmoxicillin 875 mg/1Tablet, CoatedOralPreferred Pharmaceuticals Inc.68788-406268788-4062-02
AmoxicillinAmoxicillin 400 mg/5mLFor suspensionOralREMEDYREPACK INC.70518-452970518-4529-00
AmoxicillinAmoxicillin 400 mg/5mLPowder, For suspensionOralREMEDYREPACK INC.70518-452270518-4522-00

All 275 Amoxicillin NDCs

Other NDCs under ANDA 065256

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

FDA NDC Directory listings under ANDA 065256
ProductStrengthForm · routeLabelerProduct NDC
AmoxicillinAmoxicillin 875 mg/1Tablet, Film coatedOralQPharma, Inc.42708-078
AmoxicillinAmoxicillin 500 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-0709
AmoxicillinAmoxicillin 875 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-0713
AmoxicillinAmoxicillin 875 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-0714
AmoxicillinAmoxicillin 875 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-1595
AmoxicillinAmoxicillin 875 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-1596
AmoxicillinAmoxicillin 500 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-1825
AmoxicillinAmoxicillin 500 mg/1Tablet, Film coatedOralRising Pharma Holdings, Inc.57237-028
AmoxicillinAmoxicillin 875 mg/1Tablet, Film coatedOralRising Pharma Holdings, Inc.57237-029
AmoxicillinAmoxicillin 500 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-798
AmoxicillinAmoxicillin 875 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-809
AmoxicillinAmoxicillin 875 mg/1Tablet, Film coatedOralProficient Rx LP63187-325
AmoxicillinAmoxicillin 875 mg/1Tablet, Film coatedOralProficient Rx LP63187-729
AmoxicillinAmoxicillin 875 mg/1Tablet, Film coatedOralBryant Ranch Prepack63629-4777
AmoxicillinAmoxicillin 500 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-014
AmoxicillinAmoxicillin 875 mg/1Tablet, Film coatedOralCoupler LLC67046-0015
AmoxicillinAmoxicillin 875 mg/1Tablet, Film coatedOralCoupler LLC67046-0734
AmoxicillinAmoxicillin 500 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-2911
AmoxicillinAmoxicillin 500 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals, Inc.68071-3675
AmoxicillinAmoxicillin 500 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-3872

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