NDC codes

FDA NDC Directory
Product NDC (as listed)0143-9249Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00143-9249Add 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
0143-9249-20001439249200014392492020 TABLET in 1 BOTTLE (0143-9249-20)Marketed from Aug 23, 2016

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

Generic name (nonproprietary)
amoxicillin and clavulanate potassium
Active ingredients
Amoxicillin — 875 mg/1Clavulanate potassium — 125 mg/1
Dosage form
Tablet
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 203824
Marketing start
Listing expires
Other FDA classes
Penicillins (Chemical structure)beta Lactamase Inhibitors (Mechanism)
Identifiers
Product ID 0143-9249_46aeb040-bd8f-4fcf-bfb7-98a8efc0a368SPL ID 46aeb040-bd8f-4fcf-bfb7-98a8efc0a368SPL set ID 52ab3500-d088-4693-acea-9b83c0843f66RxCUI 562508UNII 804826J2HU, Q42OMW3AT8UPC 0301439249207
Pharmacologic class
Penicillin-class Antibacterial; beta Lactamase Inhibitor

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

N400143924920 followed by a unit qualifier and the quantity

Package 00143-9249-20. 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 and Clavulanate Potassium Tablets are indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below: Lower Respiratory Tract Infections -caused by beta‑lactamase‑producing isolates of Haemophilus influenzae and Moraxella catarrhalis . Acute Bacterial Otitis Media -caused by beta‑lactamase‑producing isolates of H. influenzae and M. catarrhalis . Sinusitis -caused by beta‑lactamase‑producing isolates of H. influenzae and M. catarrhalis . Skin and Skin Structure Infections -caused by beta‑lactamase‑producing isolates of Staphylococcus aureus , Escherichia coli , and Klebsiella species…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0143-9249

What is NDC 0143-9249?
0143-9249 is the product NDC for Amoxicillin and Clavulanate Potassium, Amoxicillin 875 mg/1; Clavulanate potassium 125 mg/1 tablet, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Amoxicillin and Clavulanate Potassium.
What is the active ingredient?
Amoxicillin, Clavulanate potassium.
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 and Clavulanate Potassium?
200 other product NDCs are listed under this name. See all Amoxicillin and Clavulanate Potassium 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 and Clavulanate Potassium NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Amoxicillin And Clavulanate PotassiumAmoxicillin 875 mg/1; Clavulanate potassium 125 mg/1Tablet, CoatedOralREMEDYREPACK INC.70518-475870518-4758-00
Amoxicillin and Clavulanate PotassiumAmoxicillin 400 mg/5mL; Clavulanic acid 57 mg/5mLPowder, For suspensionOralPreferred Pharmaceuticals Inc.68788-417968788-4179-01
Amoxicillin And Clavulanate PotassiumAmoxicillin 500 mg/1; Clavulanate potassium 125 mg/1Tablet, Film coatedOralCoupler LLC67046-036667046-0366-03
Amoxicillin and Clavulanate PotassiumAmoxicillin 875 mg/1; Clavulanate potassium 125 mg/1Tablet, Film coatedOralCoupler LLC67046-095567046-0955-03
Amoxicillin and Clavulanate PotassiumAmoxicillin 562.5 mg/1 + 2 more ingredientsTablet, Film coated, Extended releaseOralUSAntibiotics, LLC81964-22081964-0220-2881964-0220-40
Amoxicillin and Clavulanate PotassiumAmoxicillin 875 mg/1; Clavulanate potassium 125 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-442470518-4424-00
Amoxicillin and Clavulanate PotassiumAmoxicillin 875 mg/1; Clavulanate potassium 125 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-883668788-8836-02
Amoxicillin and Clavulanate PotassiumAmoxicillin 600 mg/5mL; Clavulanate potassium 42.9 mg/5mLSuspensionOralPreferred Pharmaceuticals Inc.68788-877068788-8770-0168788-8770-07
Amoxicillin and Clavulanate PotassiumAmoxicillin 875 mg/1; Clavulanate potassium 125 mg/1Tablet, Film coatedOralDevatis, Inc.73043-00673043-0006-20
Amoxicillin and Clavulanate PotassiumAmoxicillin 500 mg/1; Clavulanate potassium 125 mg/1Tablet, Film coatedOralDevatis, Inc.73043-00773043-0007-20

All 201 Amoxicillin and Clavulanate Potassium NDCs

Other NDCs under ANDA 203824

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

FDA NDC Directory listings under ANDA 203824
ProductStrengthForm · routeLabelerProduct NDC
Amoxicillin and Clavulanate PotassiumAmoxicillin 875 mg/1; Clavulanate potassium 125 mg/1TabletOralProficient Rx LP82804-177
Amoxicillin and Clavulanate PotassiumAmoxicillin 875 mg/1; Clavulanate potassium 125 mg/1TabletOralREMEDYREPACK INC.70518-4148
Amoxicillin and Clavulanate PotassiumAmoxicillin 875 mg/1; Clavulanate potassium 125 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-4967
Amoxicillin and Clavulanate PotassiumAmoxicillin 875 mg/1; Clavulanate potassium 125 mg/1TabletOralA-S Medication Solutions50090-3179
Amoxicillin and Clavulanate PotassiumAmoxicillin 875 mg/1; Clavulanate potassium 125 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-5026
Amoxicillin and Clavulanate PotassiumAmoxicillin 875 mg/1; Clavulanate potassium 125 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.72789-147
Amoxicillin and Clavulanate PotassiumAmoxicillin 875 mg/1; Clavulanate potassium 125 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.72789-421
Amoxicillin and Clavulanate PotassiumAmoxicillin 875 mg/1; Clavulanate potassium 125 mg/1TabletOralNuCare Pharmaceuticals,Inc.68071-5057
Amoxicillin and Clavulanate PotassiumAmoxicillin 875 mg/1; Clavulanate potassium 125 mg/1TabletOralA-S Medication Solutions50090-7415
Amoxicillin and Clavulanate PotassiumAmoxicillin 875 mg/1; Clavulanate potassium 125 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.72789-253

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