NDC codes

FDA NDC Directory
Product NDC (as listed)0143-9285Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00143-9285Add 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
0143-9285-010014392850100143928501100 TABLET, COATED in 1 BOTTLE (0143-9285-01)Marketed from Mar 29, 2006
0143-9285-20001439285200014392852020 TABLET, COATED in 1 BOTTLE (0143-9285-20)Marketed from Mar 29, 2006

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 875 mg/1
Dosage form
Tablet, Coated
Route
Oral
Labeler
Hikma Pharmaceuticals USA Inc.NDC labeler code 0143
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 065255
Marketing start
Listing expires
Other FDA classes
Penicillins (Chemical structure)
Identifiers
Product ID 0143-9285_a4cd19b3-f938-4afe-9409-3bdea10deb63SPL ID a4cd19b3-f938-4afe-9409-3bdea10deb63SPL set ID c8591c2a-92ef-4432-b19a-bb46063047eeRxCUI 308194UNII 804826J2HUUPC 0301439285205, 0301439285014

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

N400143928501 followed by a unit qualifier and the quantity

Package 00143-9285-01. 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 tablets 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 tablets 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 tablets are indicated in the treatment of infections due to sus…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0143-9285

What is NDC 0143-9285?
0143-9285 is the product NDC for Amoxicillin, Amoxicillin 875 mg/1 tablet, coated, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 2 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?
Hikma Pharmaceuticals USA Inc., NDC labeler code 0143. 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 065255

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

FDA NDC Directory listings under ANDA 065255
ProductStrengthForm · routeLabelerProduct NDC
AmoxicillinAmoxicillin 875 mg/1Tablet, CoatedOralPD-Rx Pharmaceuticals, Inc.43063-885
AmoxicillinAmoxicillin 875 mg/1Tablet, CoatedOralA-S Medication Solutions50090-5863
AmoxicillinAmoxicillin 875 mg/1Tablet, CoatedOralA-S Medication Solutions50090-5880
AmoxicillinAmoxicillin 875 mg/1Tablet, CoatedOralRedpharm Drug67296-2328
AmoxicillinAmoxicillin 875 mg/1Tablet, CoatedOralNuCare Pharmaceuticals, Inc.68071-3716
AmoxicillinAmoxicillin 875 mg/1Tablet, CoatedOralPreferred Pharmaceuticals Inc.68788-4062
AmoxicillinAmoxicillin 875 mg/1Tablet, CoatedOralPD-Rx Pharmaceuticals, Inc.72789-224
AmoxicillinAmoxicillin 875 mg/1Tablet, CoatedOralAsclemed USA, Inc.76420-138
AmoxicillinAmoxicillin 875 mg/1Tablet, CoatedOralProficient Rx LP82804-200

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