Cefprozil NDC 16714-399

NDC codes

FDA NDC Directory

Product NDC (as listed)16714-399Labeler and product segments. Claims need a package NDC.

Product NDC at billing width16714-0399Add 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
16714-399-01	16714039901	50 TABLET, FILM COATED in 1 BOTTLE (16714-399-01)Marketed from May 24, 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 — 500 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: NorthStar Rx LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 065340
Marketing start: May 24, 2007
Listing expires: Dec 31, 2026
Identifiers: Product ID 16714-399_1fef82c2-7104-4649-bf85-6d7bef37262eSPL ID 1fef82c2-7104-4649-bf85-6d7bef37262eSPL set ID 6133611e-19c1-4df2-8c23-8573aaf63020RxCUI 197452, 197453UNII 4W0459ZA4V

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

N416714039901 followed by a unit qualifier and the quantity

Package 16714-0399-01. 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 5, 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 tablets are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorg…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 065340

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

FDA NDC Directory listings under ANDA 065340
Product	Strength	Form · route	Labeler	Product NDC
Cefprozil	Cefprozil 500 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-1710
Cefprozil	Cefprozil 250 mg/1	Tablet, Film coatedOral	Rising Pharma Holdings, Inc.	57237-036
Cefprozil	Cefprozil 500 mg/1	Tablet, Film coatedOral	Rising Pharma Holdings, Inc.	57237-037
Cefprozil	Cefprozil 250 mg/1	Tablet, Film coatedOral	NorthStar Rx LLC	16714-398
Cefprozil	Cefprozil 250 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	65862-068
Cefprozil	Cefprozil 500 mg/1	Tablet, Film coatedOral	Aurobindo Pharma Limited	65862-069