Prescription drug · ANDA

Amoxicillin NDC 65862-071

Amoxicillin 400 mg/5mL · Powder, For suspension · Oral · Aurobindo Pharma Limited

NDC codes

FDA NDC Directory
Product NDC (as listed)65862-071Labeler and product segments. Claims need a package NDC.
Product NDC at billing width65862-0071Add 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
65862-071-0165862007101100 mL in 1 BOTTLE (65862-071-01)Marketed from Dec 28, 2006
65862-071-506586200715050 mL in 1 BOTTLE (65862-071-50)Marketed from Dec 28, 2006
65862-071-756586200717575 mL in 1 BOTTLE (65862-071-75)Marketed from Dec 28, 2006

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 — 400 mg/5mL
Dosage form
Powder, For suspension
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 065334
Marketing start
Listing expires
Other FDA classes
Penicillins (Chemical structure)
Identifiers
Product ID 65862-071_3e3ca279-1838-4348-a01c-df10a8bcb8b9SPL ID 3e3ca279-1838-4348-a01c-df10a8bcb8b9SPL set ID 3cacd754-73f4-496e-a529-9ca39fa6692dRxCUI 308189, 313850UNII 804826J2HUUPC 0365862071019, 0365862070012

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

N465862007101 followed by a unit qualifier and the quantity

Package 65862-0071-01. 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…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

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
ProductStrengthForm · routeLabelerProduct NDC
AmoxicillinAmoxicillin 400 mg/5mLPowder, For suspensionOralA-S Medication Solutions50090-6355
AmoxicillinAmoxicillin 400 mg/5mLPowder, For suspensionOralNuCare Pharmaceuticals,Inc.68071-5109
AmoxicillinAmoxicillin 400 mg/5mLPowder, For suspensionOralProficient Rx LP63187-262
AmoxicillinAmoxicillin 400 mg/5mLPowder, For suspensionOralProficient Rx LP63187-335
AmoxicillinAmoxicillin 400 mg/5mLPowder, For suspensionOralREMEDYREPACK INC.70518-4522
AmoxicillinAmoxicillin 400 mg/5mLPowder, For suspensionOralDIRECT RX61919-401
AmoxicillinAmoxicillin 200 mg/5mLPowder, For suspensionOralRising Pharma Holdings, Inc.57237-032
AmoxicillinAmoxicillin 400 mg/5mLPowder, For suspensionOralRising Pharma Holdings, Inc.57237-033
AmoxicillinAmoxicillin 400 mg/5mLPowder, For suspensionOralPreferred Pharmaceuticals Inc.68788-8325
AmoxicillinAmoxicillin 200 mg/5mLPowder, For suspensionOralPreferred Pharmaceuticals Inc.68788-8324
AmoxicillinAmoxicillin 400 mg/5mLPowder, For suspensionOralDirectRx72189-285
AmoxicillinAmoxicillin 200 mg/5mLPowder, For suspensionOralProficient Rx LP71205-775
AmoxicillinAmoxicillin 200 mg/5mLPowder, For suspensionOralAurobindo Pharma Limited65862-070
AmoxicillinAmoxicillin 400 mg/5mLPowder, For suspensionOralA-S Medication Solutions50090-6323
AmoxicillinAmoxicillin 400 mg/5mLPowder, For suspensionOralA-S Medication Solutions50090-6680

Med-Code uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in
Amoxicillin NDC 65862-071 | Med-Code