Cefadroxil NDC 57237-097

NDC codes

FDA NDC Directory

Product NDC (as listed)57237-097Labeler and product segments. Claims need a package NDC.

Product NDC at billing width57237-0097Add 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 NDC	11-digit (billing)	Package	Copy
57237-097-01	57237009701	100 mL in 1 BOTTLE (57237-097-01)Marketed from Apr 25, 2013
57237-097-50	57237009750	50 mL in 1 BOTTLE (57237-097-50)Marketed from Apr 25, 2013

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): Cefadroxil
Generic name (nonproprietary): cefadroxil
Active ingredients: Cefadroxil — 250 mg/5mL
Dosage form: Powder, For suspension
Route: Oral
Labeler: Rising Pharma Holdings, Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 065349
Marketing start: Apr 25, 2013
Listing expires: Dec 31, 2026
Other FDA classes: Cephalosporins (Chemical structure)
Identifiers: Product ID 57237-097_59b4c983-458c-4363-b2e6-4253a2bc7992SPL ID 59b4c983-458c-4363-b2e6-4253a2bc7992SPL set ID 6e4111d3-f11b-403c-b340-b216022709dfRxCUI 105171, 309048UNII 280111G160
Pharmacologic class: Cephalosporin Antibacterial

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

N457237009701 followed by a unit qualifier and the quantity

Package 57237-0097-01. 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 Feb 9, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE Cefadroxil is indicated for the treatment of patients with infection caused by susceptible strains of the designated organisms in the following diseases: Urinary tract infections caused by E. coli, P. mirabilis, and Klebsiella species. Skin and skin structure infections caused by staphylococci and/or streptococci. Pharyngitis and/or tonsillitis caused by Streptococcus pyogenes (Group A beta-hemolytic streptococci). Note: Only penicillin by the intramuscular route of administration has been shown to be effective in the prophylaxis of rheumatic fever. Cefadroxil is generally effective in the eradication of streptococci from the oropharynx. However, data establishing the e…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 065349

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

FDA NDC Directory listings under ANDA 065349
Product	Strength	Form · route	Labeler	Product NDC
Cefadroxil	Cefadroxil 250 mg/5mL	Powder, For suspensionOral	NorthStar Rx LLC	16714-389
Cefadroxil	Cefadroxil 500 mg/5mL	Powder, For suspensionOral	Rising Pharma Holdings, Inc.	57237-098
Cefadroxil	Cefadroxil 500 mg/5mL	Powder, For suspensionOral	NorthStar Rx LLC	16714-390
Cefadroxil	Cefadroxil 500 mg/5mL	Powder, For suspensionOral	Aurobindo Pharma Limited	65862-084
Cefadroxil	Cefadroxil 250 mg/5mL	Powder, For suspensionOral	Aurobindo Pharma Limited	65862-083