NDC codes

FDA NDC Directory
Product NDC (as listed)65862-707Labeler and product segments. Claims need a package NDC.
Product NDC at billing width65862-0707Add 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
65862-707-016586207070165862070701100 mL in 1 BOTTLE (65862-707-01)Marketed from Sep 15, 2014
65862-707-556586207075565862070755150 mL in 1 BOTTLE (65862-707-55)Marketed from Sep 15, 2014
65862-707-80658620707806586207078080 mL in 1 BOTTLE (65862-707-80)Marketed from Sep 15, 2014

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/5mL
Dosage form
Powder, For suspension
Route
Oral
Labeler
Aurobindo Pharma LimitedNDC labeler code 65862
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 204030
Marketing start
Listing expires
Other FDA classes
Penicillins (Chemical structure)
Identifiers
Product ID 65862-707_f4a410c9-3a78-48f9-8195-915896a974ffSPL ID f4a410c9-3a78-48f9-8195-915896a974ffSPL set ID 234d0dfc-cb24-413f-b798-129c73eb848eRxCUI 239191, 313797UNII 804826J2HUUPC 0365862707017, 0365862706010

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

N465862070701 followed by a unit qualifier and the quantity

Package 65862-0707-01. 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 for oral suspension is 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 for oral suspension is 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 for oral suspension is indicated in the t…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 65862-707

What is NDC 65862-707?
65862-707 is the product NDC for Amoxicillin, Amoxicillin 250 mg/5mL powder, for suspension, 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 204030

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

FDA NDC Directory listings under ANDA 204030
ProductStrengthForm · routeLabelerProduct NDC
AmoxicillinAmoxicillin 250 mg/5mLPowder, For suspensionOralA-S Medication Solutions50090-6319
AmoxicillinAmoxicillin 250 mg/5mLPowder, For suspensionOralA-S Medication Solutions50090-6349
AmoxicillinAmoxicillin 250 mg/5mLPowder, For suspensionOralA-S Medication Solutions50090-6351
AmoxicillinAmoxicillin 250 mg/5mLPowder, For suspensionOralA-S Medication Solutions50090-6469
AmoxicillinAmoxicillin 125 mg/5mLPowder, For suspensionOralA-S Medication Solutions50090-6791
AmoxicillinAmoxicillin 125 mg/5mLPowder, For suspensionOralAurobindo Pharma Limited65862-706
AmoxicillinAmoxicillin 250 mg/5mLPowder, For suspensionOralNuCare Pharmaceuticals,Inc.68071-2397
AmoxicillinAmoxicillin 250 mg/5mLPowder, For suspensionOralProficient Rx LP82804-134

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