Cefprozil NDC 57237-035

NDC codes

FDA NDC Directory

Product NDC (as listed)57237-035Labeler and product segments. Claims need a package NDC.

Product NDC at billing width57237-0035Add 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
57237-035-01	57237003501	100 mL in 1 BOTTLE (57237-035-01)Marketed from Jan 30, 2007
57237-035-50	57237003550	50 mL in 1 BOTTLE (57237-035-50)Marketed from Jan 30, 2007
57237-035-75	57237003575	75 mL in 1 BOTTLE (57237-035-75)Marketed from Jan 30, 2007

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): Cefprozil
Generic name (nonproprietary): cefprozil
Active ingredients: Cefprozil — 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 065381
Marketing start: Jan 30, 2007
Listing expires: Dec 31, 2026
Identifiers: Product ID 57237-035_2288a04a-b86b-4c3b-8e12-e61531cf5b43SPL ID 2288a04a-b86b-4c3b-8e12-e61531cf5b43SPL set ID d7fac9cc-30e1-4762-a01b-04f1bd3b2a56RxCUI 309080, 309081UNII 4W0459ZA4VUPC 0357237035504

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

N457237003501 followed by a unit qualifier and the quantity

Package 57237-0035-01. 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 May 18, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefprozil and other antibacterial drugs, cefprozil should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Cefprozil for oral suspension is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designat…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 065381

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

FDA NDC Directory listings under ANDA 065381
Product	Strength	Form · route	Labeler	Product NDC
Cefprozil	Cefprozil 125 mg/5mL	Powder, For suspensionOral	Aurobindo Pharma Limited	65862-099
Cefprozil	Cefprozil 250 mg/5mL	Powder, For suspensionOral	Aurobindo Pharma Limited	65862-100
Cefprozil	Cefprozil 250 mg/5mL	Powder, For suspensionOral	A-S Medication Solutions	50090-3226
Cefprozil	Cefprozil 125 mg/5mL	Powder, For suspensionOral	Rising Pharma Holdings, Inc.	57237-034
Cefprozil	Cefprozil 125 mg/5mL	Powder, For suspensionOral	NorthStar Rx LLC	16714-396
Cefprozil	Cefprozil 250 mg/5mL	Powder, For suspensionOral	NorthStar Rx LLC	16714-397