Prescription drug · ANDA

Amoxicillin and Clavulanate Potassium NDC 68071-3807

Amoxicillin 200 mg/5mL; Clavulanate potassium 28.5 mg/5mL · Powder, For suspension · Oral · NuCare Pharmaceuticals, Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)68071-3807Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68071-3807Add 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
68071-3807-168071380701100 mL in 1 BOTTLE (68071-3807-1)Marketed from Mar 11, 2025

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 and Clavulanate Potassium
Generic name (nonproprietary)
amoxicillin and clavulanate potassium
Active ingredients
Amoxicillin — 200 mg/5mLClavulanate potassium — 28.5 mg/5mL
Dosage form
Powder, For suspension
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 201090
Marketing start
Listing expires
Other FDA classes
Penicillins (Chemical structure)beta Lactamase Inhibitors (Mechanism)
Identifiers
Product ID 68071-3807_30144cfc-0fb1-8d62-e063-6394a90acba4SPL ID 30144cfc-0fb1-8d62-e063-6394a90acba4SPL set ID 30144e2e-d336-8fa3-e063-6394a90a6068RxCUI 617423UNII 804826J2HU, Q42OMW3AT8UPC 0368071380712
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

N468071380701 followed by a unit qualifier and the quantity

Package 68071-3807-01. 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)

Amoxicillin and clavulanate potassium for oral suspension is 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 Kle…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 201090

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

FDA NDC Directory listings under ANDA 201090
ProductStrengthForm · routeLabelerProduct NDC
Amoxicillin/Clav Pot Oral SuspAmoxicillin 400 mg/5mL; Clavulanate potassium 57 mg/5mLPowder, For suspensionOralDirect_Rx72189-367
Amoxicillin and Clavulanate PotassiumAmoxicillin 200 mg/5mL; Clavulanate potassium 28.5 mg/5mLPowder, For suspensionOralHAWAII REPACK, INC.85534-0080
Amoxicillin and Clavulanate PotassiumAmoxicillin 400 mg/5mL; Clavulanate potassium 57 mg/5mLPowder, For suspensionOralA-S Medication Solutions50090-6694
Amoxicillin and Clavulanate PotassiumAmoxicillin 400 mg/5mL; Clavulanate potassium 57 mg/5mLPowder, For suspensionOralA-S Medication Solutions50090-5873
Amoxicillin and Clavulanate PotassiumAmoxicillin 200 mg/5mL; Clavulanate potassium 28.5 mg/5mLPowder, For suspensionOralA-S Medication Solutions50090-5932
Amoxicillin and Clavulanate PotassiumAmoxicillin 400 mg/5mL; Clavulanate potassium 57 mg/5mLPowder, For suspensionOralNuCare Pharmaceuticals,Inc.68071-2227
Amoxicillin and Clavulanate PotassiumAmoxicillin 400 mg/5mL; Clavulanate potassium 57 mg/5mLPowder, For suspensionOralA-S Medication Solutions50090-3309
Amoxicillin and Clavulanate PotassiumAmoxicillin 200 mg/5mL; Clavulanate potassium 28.5 mg/5mLPowder, For suspensionOralNorthStar Rx LLC16714-292
Amoxicillin and Clavulanate PotassiumAmoxicillin 400 mg/5mL; Clavulanate potassium 57 mg/5mLPowder, For suspensionOralNorthStar Rx LLC16714-293
Amoxicillin and Clavulanate PotassiumAmoxicillin 400 mg/5mL; Clavulanate potassium 57 mg/5mLPowder, For suspensionOralProficient Rx LP71205-462
Amoxicillin and Clavulanate PotassiumAmoxicillin 200 mg/5mL; Clavulanate potassium 28.5 mg/5mLPowder, For suspensionOralPreferred Pharmaceuticals Inc.68788-8306
Amoxicillin and Clavulanate PotassiumAmoxicillin 400 mg/5mL; Clavulanate potassium 57 mg/5mLPowder, For suspensionOralPreferred Pharmaceuticals Inc.68788-8318
Amoxicillin and Clavulanate PotassiumAmoxicillin 200 mg/5mL; Clavulanate potassium 28.5 mg/5mLPowder, For suspensionOralAurobindo Pharma Limited65862-533
Amoxicillin and Clavulanate PotassiumAmoxicillin 400 mg/5mL; Clavulanate potassium 57 mg/5mLPowder, For suspensionOralAurobindo Pharma Limited65862-534
Amoxicillin and Clavulanate PotassiumAmoxicillin 400 mg/5mL; Clavulanate potassium 57 mg/5mLPowder, For suspensionOralNuCare Pharmaceuticals,Inc.68071-2518
Amoxicillin and Clavulanate PotassiumAmoxicillin 200 mg/5mL; Clavulanate potassium 28.5 mg/5mLPowder, For suspensionOralAsclemed USA, Inc.76420-859
Amoxicillin and Clavulanate PotassiumAmoxicillin 400 mg/5mL; Clavulanate potassium 57 mg/5mLPowder, For suspensionOralAsclemed USA, Inc.76420-864
Amoxicillin and Clavulanate PotassiumAmoxicillin 200 mg/5mL; Clavulanate potassium 28.5 mg/5mLPowder, For suspensionOralA-S Medication Solutions50090-6222
Amoxicillin and Clavulanate PotassiumAmoxicillin 400 mg/5mL; Clavulanate potassium 57 mg/5mLPowder, For suspensionOralHAWAII REPACK, INC.85534-0041

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