Prescription drug · ANDA

Amoxicillin and Clavulanate Potassium NDC 16714-294

Amoxicillin 600 mg/5mL; Clavulanate potassium 42.9 mg/5mL · Powder, For suspension · Oral · NorthStar Rx LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)16714-294Labeler and product segments. Claims need a package NDC.
Product NDC at billing width16714-0294Add 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
16714-294-011671402940175 mL in 1 BOTTLE (16714-294-01)Marketed from Dec 20, 2011
16714-294-0216714029402125 mL in 1 BOTTLE (16714-294-02)Marketed from Dec 20, 2011
16714-294-0316714029403200 mL in 1 BOTTLE (16714-294-03)Marketed from Dec 20, 2011

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 and Clavulanate Potassium
Generic name (nonproprietary)
amoxicillin and clavulanate potassium
Active ingredients
Amoxicillin — 600 mg/5mLClavulanate potassium — 42.9 mg/5mL
Dosage form
Powder, For suspension
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 201091
Marketing start
Listing expires
Other FDA classes
Penicillins (Chemical structure)beta Lactamase Inhibitors (Mechanism)
Identifiers
Product ID 16714-294_04e2b9cd-a5cb-4762-86f9-1afbd53b4bc6SPL ID 04e2b9cd-a5cb-4762-86f9-1afbd53b4bc6SPL set ID df4136c0-9efd-42c3-a487-e728e8b91275RxCUI 617993UNII 804826J2HU, Q42OMW3AT8
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

N416714029401 followed by a unit qualifier and the quantity

Package 16714-0294-01. 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 pediatric patients aged 3 months to 12 years weighing less than or equal to 40 kg with: Recurrent or persistent acute otitis media due to S. pneumoniae (penicillin MICs less than or equal to 2 mcg/mL), H. influenzae (including beta-lactamase-producing strains), or M. catarrhalis (including beta-lactamase-producing strains) characterized by the following risk factors: - Antibacterial drug exposure for acute otitis media within the preceding 3 months, and either of the following: 1) age 2 years, or younger or 2) day care attendance [see Microbiology (12.4) ] . Limitations of Use Amoxicillin and clavulan…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 201091

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

FDA NDC Directory listings under ANDA 201091
ProductStrengthForm · routeLabelerProduct NDC
Amoxicillin and Clavulanate PotassiumAmoxicillin 600 mg/5mL; Clavulanate potassium 42.9 mg/5mLPowder, For suspensionOralNuCare Pharmaceuticals,Inc.68071-5144
Amoxicillin and Clavulanate PotassiumAmoxicillin 600 mg/5mL; Clavulanate potassium 42.9 mg/5mLPowder, For suspensionOralA-S Medication Solutions50090-1857
Amoxicillin and Clavulanate PotassiumAmoxicillin 600 mg/5mL; Clavulanate potassium 42.9 mg/5mLPowder, For suspensionOralProficient Rx LP71205-036
Amoxicillin and Clavulanate PotassiumAmoxicillin 600 mg/5mL; Clavulanate potassium 42.9 mg/5mLPowder, For suspensionOralPreferred Pharmaceuticals, Inc.68788-0483
Amoxicillin and Clavulanate PotassiumAmoxicillin 600 mg/5mL; Clavulanate potassium 42.9 mg/5mLPowder, For suspensionOralNuCare Pharmaceuticals,Inc.68071-5207
Amoxicillin and Clavulanate PotassiumAmoxicillin 600 mg/5mL; Clavulanate potassium 42.9 mg/5mLPowder, For suspensionOralNuCare Pharmaceuticals,Inc.68071-2355
Amoxicillin and Clavulanate PotassiumAmoxicillin 600 mg/5mL; Clavulanate potassium 42.9 mg/5mLPowder, For suspensionOralA-S Medication Solutions50090-2219
Amoxicillin and Clavulanate PotassiumAmoxicillin 600 mg/5mL; Clavulanate potassium 42.9 mg/5mLPowder, For suspensionOralRedpharm Drug67296-2234
Amoxicillin and Clavulanate PotassiumAmoxicillin 600 mg/5mL; Clavulanate potassium 42.9 mg/5mLPowder, For suspensionOralProficient Rx LP82804-017
Amoxicillin and Clavulanate PotassiumAmoxicillin 600 mg/5mL; Clavulanate potassium 42.9 mg/5mLPowder, For suspensionOralAurobindo Pharma Limited65862-535
Amoxicillin and Clavulanate PotassiumAmoxicillin 600 mg/5mL; Clavulanate potassium 42.9 mg/5mLPowder, For suspensionOralNuCare Pharmaceuticals,Inc.68071-2852

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