cefprozil

Generic: cefprozil

Labeler: teva pharmaceuticals usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cefprozil
Generic Name cefprozil
Labeler teva pharmaceuticals usa, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cefprozil 500 mg/1

Manufacturer
Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 0093-1078
Product ID 0093-1078_c226712f-00c2-407f-8b40-5ed1be54dfb8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065208
Listing Expiration 2026-12-31
Marketing Start 2005-12-23

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00931078
Hyphenated Format 0093-1078

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 ANDA065208 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 50 TABLET, FILM COATED in 1 BOTTLE (0093-1078-53)
source: ndc

Packages (1)

0093-1078-53 50 TABLET, FILM COATED in 1 BOTTLE (0093-1078-53)

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": "c226712f-00c2-407f-8b40-5ed1be54dfb8", "openfda": {"nui": ["N0000175488", "M0003827"], "unii": ["4W0459ZA4V"], "rxcui": ["197452", "197453"], "spl_set_id": ["3391de8b-7bc9-4624-a5c4-836135b39d99"], "pharm_class_cs": ["Cephalosporins [CS]"], "pharm_class_epc": ["Cephalosporin Antibacterial [EPC]"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 TABLET, FILM COATED in 1 BOTTLE (0093-1078-53)", "package_ndc": "0093-1078-53", "marketing_start_date": "20051223"}], "brand_name": "Cefprozil", "product_id": "0093-1078_c226712f-00c2-407f-8b40-5ed1be54dfb8", "dosage_form": "TABLET, FILM COATED", "product_ndc": "0093-1078", "generic_name": "Cefprozil", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cefprozil", "active_ingredients": [{"name": "CEFPROZIL", "strength": "500 mg/1"}], "application_number": "ANDA065208", "marketing_category": "ANDA", "marketing_start_date": "20051223", "listing_expiration_date": "20261231"}