NDC codes

FDA NDC Directory
Product NDC (as listed)85534-0040Labeler and product segments. Claims need a package NDC.
Product NDC at billing width85534-0040Add 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
85534-0040-08553400400020 CAPSULE in 1 BOTTLE (85534-0040-0)Marketed from Jul 17, 2026
85534-0040-18553400400130 CAPSULE in 1 BOTTLE (85534-0040-1)Marketed from Jul 17, 2026
85534-0040-28553400400250 CAPSULE in 1 BOTTLE (85534-0040-2)Marketed from Jul 17, 2026
85534-0040-38553400400360 CAPSULE in 1 BOTTLE (85534-0040-3)Marketed from Jul 17, 2026
85534-0040-48553400400490 CAPSULE in 1 BOTTLE (85534-0040-4)Marketed from Jul 17, 2026
85534-0040-585534004005100 CAPSULE in 1 BOTTLE (85534-0040-5)Marketed from Jul 17, 2026
85534-0040-685534004006120 CAPSULE in 1 BOTTLE (85534-0040-6)Marketed from Jul 17, 2026
85534-0040-785534004007500 CAPSULE in 1 BOTTLE (85534-0040-7)Marketed from Jul 17, 2026

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
HAWAII REPACK, INC.NDC labeler code 85534
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 85534-0040_56c86ae4-03b4-8217-e063-6294a90a8910SPL ID 56c86ae4-03b4-8217-e063-6294a90a8910SPL set ID bf130964-8386-4ab7-8d3b-fb0174670afcRxCUI 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

N485534004000 followed by a unit qualifier and the quantity

Package 85534-0040-00. 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 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 of infections due to…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 85534-0040

What is NDC 85534-0040?
85534-0040 is the product NDC for Amoxicillin, Amoxicillin 500 mg/1 capsule, listed with the FDA by HAWAII REPACK, INC.. It has 8 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?
HAWAII REPACK, INC., NDC labeler code 85534. 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?
268 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 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
AmoxicillinAmoxicillin 400 mg/5mLPowder, For suspensionOralREMEDYREPACK INC.70518-452170518-4521-00

All 269 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 250 mg/1CapsuleOralNorthStar Rx LLC16714-298
AmoxicillinAmoxicillin 500 mg/1CapsuleOralNorthStar Rx LLC16714-299
AmoxicillinAmoxicillin 500 mg/1CapsuleOralQPharma Inc42708-076
AmoxicillinAmoxicillin 250 mg/1CapsuleOralPD-Rx Pharmaceuticals, Inc.43063-574
AmoxicillinAmoxicillin 500 mg/1CapsuleOralPD-Rx Pharmaceuticals, Inc.43063-820
AmoxicillinAmoxicillin 500 mg/1CapsuleOralPD-Rx Pharmaceuticals, Inc.43063-915
AmoxicillinAmoxicillin 500 mg/1CapsuleOralA-S Medication Solutions50090-1511
AmoxicillinAmoxicillin 500 mg/1CapsuleOralA-S Medication Solutions50090-1512
AmoxicillinAmoxicillin 500 mg/1CapsuleOralA-S Medication Solutions50090-1513
AmoxicillinAmoxicillin 500 mg/1CapsuleOralA-S Medication Solutions50090-1514
AmoxicillinAmoxicillin 500 mg/1CapsuleOralA-S Medication Solutions50090-1794
AmoxicillinAmoxicillin 500 mg/1CapsuleOralA-S Medication Solutions50090-1795
AmoxicillinAmoxicillin 500 mg/1CapsuleOralA-S Medication Solutions50090-1796
AmoxicillinAmoxicillin 500 mg/1CapsuleOralA-S Medication Solutions50090-1797
AmoxicillinAmoxicillin 500 mg/1CapsuleOralA-S Medication Solutions50090-1810
AmoxicillinAmoxicillin 500 mg/1CapsuleOralA-S Medication Solutions50090-1811
AmoxicillinAmoxicillin 500 mg/1CapsuleOralA-S Medication Solutions50090-1812
AmoxicillinAmoxicillin 500 mg/1CapsuleOralA-S Medication Solutions50090-1813
AmoxicillinAmoxicillin 250 mg/1CapsuleOralA-S Medication Solutions50090-1826
AmoxicillinAmoxicillin 500 mg/1CapsuleOralNorthwind Pharmaceuticals, LLC51655-156

Showing 20 of 40.

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