cefprozil

Generic: cefprozil

Labeler: northstar rx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cefprozil
Generic Name cefprozil
Labeler northstar rx llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cefprozil 500 mg/1

Manufacturer
NorthStar Rx LLC

Identifiers & Regulatory

Product NDC 16714-399
Product ID 16714-399_1fef82c2-7104-4649-bf85-6d7bef37262e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065340
Listing Expiration 2026-12-31
Marketing Start 2007-05-24

Pharmacologic Class

Established (EPC)
cephalosporin antibacterial [epc]
Chemical Structure
cephalosporins [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16714399
Hyphenated Format 16714-399

Supplemental Identifiers

RxCUI
197452 197453
UNII
4W0459ZA4V
NUI
N0000175488 M0003827

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name cefprozil (source: ndc)
Generic Name cefprozil (source: ndc)
Application Number ANDA065340 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 50 TABLET, FILM COATED in 1 BOTTLE (16714-399-01)
source: ndc

Packages (1)

16714-399-01 50 TABLET, FILM COATED in 1 BOTTLE (16714-399-01)

Ingredients (1)

cefprozil (500 mg/1)

Linked Drug Pages (1)

Cefprozil ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "1fef82c2-7104-4649-bf85-6d7bef37262e", "openfda": {"nui": ["N0000175488", "M0003827"], "unii": ["4W0459ZA4V"], "rxcui": ["197452", "197453"], "spl_set_id": ["6133611e-19c1-4df2-8c23-8573aaf63020"], "pharm_class_cs": ["Cephalosporins [CS]"], "pharm_class_epc": ["Cephalosporin Antibacterial [EPC]"], "manufacturer_name": ["NorthStar Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 TABLET, FILM COATED in 1 BOTTLE (16714-399-01)", "package_ndc": "16714-399-01", "marketing_start_date": "20070524"}], "brand_name": "Cefprozil", "product_id": "16714-399_1fef82c2-7104-4649-bf85-6d7bef37262e", "dosage_form": "TABLET, FILM COATED", "product_ndc": "16714-399", "generic_name": "Cefprozil", "labeler_name": "NorthStar Rx LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cefprozil", "active_ingredients": [{"name": "CEFPROZIL", "strength": "500 mg/1"}], "application_number": "ANDA065340", "marketing_category": "ANDA", "marketing_start_date": "20070524", "listing_expiration_date": "20261231"}