Prescription drug · ANDA

Amoxicillin NDC 57237-032

Amoxicillin 200 mg/5mL · Powder, For suspension · Oral · Rising Pharma Holdings, Inc.

NDC codes

FDA NDC Directory
Product NDC (as listed)57237-032Labeler and product segments. Claims need a package NDC.
Product NDC at billing width57237-0032Add 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
57237-032-0157237003201100 mL in 1 BOTTLE (57237-032-01)Marketed from Dec 28, 2006
57237-032-505723700325050 mL in 1 BOTTLE (57237-032-50)Marketed from Dec 28, 2006
57237-032-755723700327575 mL in 1 BOTTLE (57237-032-75)Marketed from Dec 28, 2006

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
Generic name (nonproprietary)
amoxicillin
Active ingredients
Amoxicillin — 200 mg/5mL
Dosage form
Powder, For suspension
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 065334
Marketing start
Listing expires
Other FDA classes
Penicillins (Chemical structure)
Identifiers
Product ID 57237-032_62bfc65c-04fe-43b5-b659-d37067b280c0SPL ID 62bfc65c-04fe-43b5-b659-d37067b280c0SPL set ID 554239db-69fe-405a-910a-d9f9e3f8b6edRxCUI 308189, 313850UNII 804826J2HU

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

N457237003201 followed by a unit qualifier and the quantity

Package 57237-0032-01. 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)

Other NDCs under ANDA 065334

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

FDA NDC Directory listings under ANDA 065334
ProductStrengthForm · routeLabelerProduct NDC
AmoxicillinAmoxicillin 400 mg/5mLPowder, For suspensionOralA-S Medication Solutions50090-6355
AmoxicillinAmoxicillin 400 mg/5mLPowder, For suspensionOralNuCare Pharmaceuticals,Inc.68071-5109
AmoxicillinAmoxicillin 400 mg/5mLPowder, For suspensionOralProficient Rx LP63187-262
AmoxicillinAmoxicillin 400 mg/5mLPowder, For suspensionOralProficient Rx LP63187-335
AmoxicillinAmoxicillin 400 mg/5mLPowder, For suspensionOralREMEDYREPACK INC.70518-4522
AmoxicillinAmoxicillin 400 mg/5mLPowder, For suspensionOralDIRECT RX61919-401
AmoxicillinAmoxicillin 400 mg/5mLPowder, For suspensionOralRising Pharma Holdings, Inc.57237-033
AmoxicillinAmoxicillin 400 mg/5mLPowder, For suspensionOralPreferred Pharmaceuticals Inc.68788-8325
AmoxicillinAmoxicillin 200 mg/5mLPowder, For suspensionOralPreferred Pharmaceuticals Inc.68788-8324
AmoxicillinAmoxicillin 400 mg/5mLPowder, For suspensionOralDirectRx72189-285
AmoxicillinAmoxicillin 200 mg/5mLPowder, For suspensionOralProficient Rx LP71205-775
AmoxicillinAmoxicillin 400 mg/5mLPowder, For suspensionOralAurobindo Pharma Limited65862-071
AmoxicillinAmoxicillin 200 mg/5mLPowder, For suspensionOralAurobindo Pharma Limited65862-070
AmoxicillinAmoxicillin 400 mg/5mLPowder, For suspensionOralA-S Medication Solutions50090-6323
AmoxicillinAmoxicillin 400 mg/5mLPowder, For suspensionOralA-S Medication Solutions50090-6680

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