NDC codes

FDA NDC Directory
Product NDC (as listed)76420-508Labeler and product segments. Claims need a package NDC.
Product NDC at billing width76420-0508Add 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
76420-508-50764200508507642005085050 CAPSULE in 1 BOTTLE (76420-508-50)Marketed from Nov 2, 2022

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 — 500 mg/1
Dosage form
Capsule
Route
Oral
Labeler
Asclemed USA, Inc.NDC labeler code 76420
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 76420-508_ec75f13d-67a5-ddb2-e053-2a95a90a1b69SPL ID ec75f13d-67a5-ddb2-e053-2a95a90a1b69SPL set ID fe9e12de-9be9-4211-9a58-c7ecd9e838d5RxCUI 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

N476420050850 followed by a unit qualifier and the quantity

Package 76420-0508-50. 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)

Amoxicillin capsules are a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms. Infections of the ear, nose, throat, genitourinary tract, skin and skin structure, and lower respiratory tract. (1.1 – 1.4) In combination for treatment of H. pylori infection and duodenal ulcer disease. (1.5) To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin capsules and other antibacterial drugs, amoxicillin capsules should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. (1.6) 1.1 Infections of the Ear, Nose, and Throat Amoxicillin capsules ar…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 76420-508

What is NDC 76420-508?
76420-508 is the product NDC for Amoxicillin, Amoxicillin 500 mg/1 capsule, listed with the FDA by Asclemed USA, Inc.. 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?
Asclemed USA, Inc., NDC labeler code 76420. 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 500 mg/1CapsuleOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0269
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 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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