cefprozil

Generic: cefprozil

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cefprozil
Generic Name cefprozil
Labeler aurobindo pharma limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cefprozil 500 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-069
Product ID 65862-069_6397ff45-3c37-40c3-a924-d036bb896b3b
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 65862069
Hyphenated Format 65862-069

Supplemental Identifiers

RxCUI
197452 197453
UPC
0365862069016
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
  • 100 TABLET, FILM COATED in 1 BOTTLE (65862-069-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (65862-069-05)
  • 30 TABLET, FILM COATED in 1 BOTTLE (65862-069-30)
  • 50 TABLET, FILM COATED in 1 BOTTLE (65862-069-50)
source: ndc

Packages (4)

65862-069-01 100 TABLET, FILM COATED in 1 BOTTLE (65862-069-01) 65862-069-05 500 TABLET, FILM COATED in 1 BOTTLE (65862-069-05) 65862-069-30 30 TABLET, FILM COATED in 1 BOTTLE (65862-069-30) 65862-069-50 50 TABLET, FILM COATED in 1 BOTTLE (65862-069-50)

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": "6397ff45-3c37-40c3-a924-d036bb896b3b", "openfda": {"nui": ["N0000175488", "M0003827"], "upc": ["0365862069016"], "unii": ["4W0459ZA4V"], "rxcui": ["197452", "197453"], "spl_set_id": ["b9111a81-07c4-4458-b994-a4ad504986d8"], "pharm_class_cs": ["Cephalosporins [CS]"], "pharm_class_epc": ["Cephalosporin Antibacterial [EPC]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (65862-069-01)", "package_ndc": "65862-069-01", "marketing_start_date": "20070524"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (65862-069-05)", "package_ndc": "65862-069-05", "marketing_start_date": "20070524"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (65862-069-30)", "package_ndc": "65862-069-30", "marketing_start_date": "20070524"}, {"sample": false, "description": "50 TABLET, FILM COATED in 1 BOTTLE (65862-069-50)", "package_ndc": "65862-069-50", "marketing_start_date": "20070524"}], "brand_name": "Cefprozil", "product_id": "65862-069_6397ff45-3c37-40c3-a924-d036bb896b3b", "dosage_form": "TABLET, FILM COATED", "product_ndc": "65862-069", "generic_name": "Cefprozil", "labeler_name": "Aurobindo Pharma Limited", "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"}