NDC codes

FDA NDC Directory
Product NDC (as listed)80425-0269Labeler and product segments. Claims need a package NDC.
Product NDC at billing width80425-0269Add 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
80425-0269-1804250269018042502690128 CAPSULE in 1 BOTTLE (80425-0269-1)Marketed from Feb 15, 2023

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 — 500 mg/1
Dosage form
Capsule
Route
Oral
Labeler
Advanced Rx Pharmacy of Tennessee, LLCNDC labeler code 80425
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 065271
Marketing start
Listing expires
Other FDA classes
Penicillins (Chemical structure)
Identifiers
Product ID 80425-0269_2a9b792b-f418-e859-e063-6394a90a30e2SPL ID 2a9b792b-f418-e859-e063-6394a90a30e2SPL set ID f4c36acc-828d-323b-e053-2a95a90a4d1cRxCUI 308191UNII 804826J2HU

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

N480425026901 followed by a unit qualifier and the quantity

Package 80425-0269-01. 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)

1. Indications and Usage 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…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 80425-0269

What is NDC 80425-0269?
80425-0269 is the product NDC for Amoxicillin, Amoxicillin 500 mg/1 capsule, listed with the FDA by Advanced Rx Pharmacy of Tennessee, LLC. 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?
Advanced Rx Pharmacy of Tennessee, LLC, NDC labeler code 80425. 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 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
ProductStrengthForm · routeLabelerProduct NDC
AmoxicillinAmoxicillin 500 mg/1CapsuleOralNuCare Pharmaceuticals,Inc.68071-4907
AmoxicillinAmoxicillin 500 mg/1CapsuleOralPD-Rx Pharmaceuticals, Inc.43063-820
AmoxicillinAmoxicillin 500 mg/1CapsuleOralAurobindo Pharma Limited65862-017
AmoxicillinAmoxicillin 250 mg/1CapsuleOralAurobindo Pharma Limited65862-016
AmoxicillinAmoxicillin 500 mg/1CapsuleOralA-S Medication Solutions50090-1512
AmoxicillinAmoxicillin 500 mg/1CapsuleOralBryant Ranch Prepack63629-7584
AmoxicillinAmoxicillin 500 mg/1CapsuleOralA-S Medication Solutions50090-1511
AmoxicillinAmoxicillin 500 mg/1CapsuleOralA-S Medication Solutions50090-1513
AmoxicillinAmoxicillin 500 mg/1CapsuleOralA-S Medication Solutions50090-1514
AmoxicillinAmoxicillin 500 mg/1CapsuleOralNuCare Pharmaceuticals,Inc.68071-4920
AmoxicillinAmoxicillin 500 mg/1CapsuleOralNuCare Pharmaceuticals,Inc.68071-3517
AmoxicillinAmoxicillin 250 mg/1CapsuleOralRedpharm Drug67296-2295
AmoxicillinAmoxicillin 500 mg/1CapsuleOralRedpharm Drug67296-2292
AmoxicillinAmoxicillin 500 mg/1CapsuleOralCoupler LLC67046-1175
AmoxicillinAmoxicillin 250 mg/1CapsuleOralNuCare Pharmaceuticals,Inc.68071-4953
AmoxicillinAmoxicillin 500 mg/1CapsuleOralAsclemed USA, Inc.76420-508
AmoxicillinAmoxicillin 250 mg/1CapsuleOralAmerican Health Packaging60687-776
AmoxicillinAmoxicillin 250 mg/1CapsuleOralAsclemed USA, Inc.76420-832
AmoxicillinAmoxicillin 500 mg/1CapsuleOralNorthwind Health Company, LLC82868-056
AmoxicillinAmoxicillin 500 mg/1CapsuleOralAmerican Health Packaging60687-787

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