Prescription drug · ANDA

Amoxicillin NDC 0143-9889

Amoxicillin 250 mg/5mL · Powder, For suspension · Oral · Hikma Pharmaceuticals USA Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)0143-9889Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00143-9889Add 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
0143-9889-010014398890100143988901100 mL in 1 BOTTLE (0143-9889-01)Marketed from Jun 19, 2006
0143-9889-150014398891500143988915150 mL in 1 BOTTLE (0143-9889-15)Marketed from Jun 19, 2006
0143-9889-80001439889800014398898080 mL in 1 BOTTLE (0143-9889-80)Marketed from Jun 19, 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 — 250 mg/5mL
Dosage form
Powder, For suspension
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 065322
Marketing start
Listing expires
Other FDA classes
Penicillins (Chemical structure)
Identifiers
Product ID 0143-9889_c2fa2c99-c735-4834-a8a5-04a30da8a002SPL ID c2fa2c99-c735-4834-a8a5-04a30da8a002SPL set ID 077f4a65-3cfb-4cb1-99f2-e27ffc5939c0RxCUI 239191, 313797UNII 804826J2HUUPC 0301439888017, 0301439889014

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

N400143988901 followed by a unit qualifier and the quantity

Package 00143-9889-01. 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 for oral suspension is 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 for oral suspension is 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 for oral suspension is indicated in the …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0143-9889

What is NDC 0143-9889?
0143-9889 is the product NDC for Amoxicillin, Amoxicillin 250 mg/5mL powder, for suspension, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 3 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 065322

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

FDA NDC Directory listings under ANDA 065322
ProductStrengthForm · routeLabelerProduct NDC
AmoxicillinAmoxicillin 250 mg/5mLPowder, For suspensionOralProficient Rx LP63187-029
AmoxicillinAmoxicillin 125 mg/5mLPowder, For suspensionOralA-S Medication Solutions50090-0406
AmoxicillinAmoxicillin 125 mg/5mLPowder, For suspensionOralA-S Medication Solutions50090-0404
AmoxicillinAmoxicillin 250 mg/5mLPowder, For suspensionOralA-S Medication Solutions50090-0405
AmoxicillinAmoxicillin 250 mg/5mLPowder, For suspensionOralA-S Medication Solutions50090-0411
AmoxicillinAmoxicillin 250 mg/5mLPowder, For suspensionOralA-S Medication Solutions50090-0407
AmoxicillinAmoxicillin 250 mg/5mLPowder, For suspensionOralPreferred Pharmaceuticals Inc.68788-8759
AmoxicillinAmoxicillin 125 mg/5mLPowder, For suspensionOralNuCare Pharmaceuticals,Inc.68071-1761
AmoxicillinAmoxicillin 125 mg/5mLPowder, For suspensionOralNuCare Pharmaceuticals,Inc.68071-1760
AmoxicillinAmoxicillin 125 mg/5mLPowder, For suspensionOralHikma Pharmaceuticals USA Inc.0143-9888
AmoxicillinAmoxicillin 250 mg/5mLPowder, For suspensionOralNuCare Pharmaceuticals,Inc.66267-993
AmoxicillinAmoxicillin 125 mg/5mLPowder, For suspensionOralProficient Rx LP63187-295
AmoxicillinAmoxicillin 250 mg/5mLPowder, For suspensionOralA-S Medication Solutions50090-2251
AmoxicillinAmoxicillin 125 mg/5mLPowder, For suspensionOralPreferred Pharmaceuticals Inc.68788-4024
AmoxicillinAmoxicillin 250 mg/5mLPowder, For suspensionOralNuCare Pharmaceuticals Inc.68071-3678
AmoxicillinAmoxicillin 250 mg/5mLPowder, For suspensionOralNuCare Pharmaceuticals,Inc.68071-2364

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