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 POWDER, FOR SUSPENSION
Routes
ORAL
Active Ingredients

cefprozil 125 mg/5mL

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-099
Product ID 65862-099_3c7c4d11-bbf8-4861-add8-0772d41daef5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065381
Listing Expiration 2026-12-31
Marketing Start 2007-01-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65862099
Hyphenated Format 65862-099

Supplemental Identifiers

RxCUI
309080 309081
UPC
0365862099013 0365862100016
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 ANDA065381 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 125 mg/5mL
source: ndc
Packaging
  • 100 mL in 1 BOTTLE (65862-099-01)
  • 50 mL in 1 BOTTLE (65862-099-50)
  • 75 mL in 1 BOTTLE (65862-099-75)
source: ndc

Packages (3)

65862-099-01 100 mL in 1 BOTTLE (65862-099-01) 65862-099-50 50 mL in 1 BOTTLE (65862-099-50) 65862-099-75 75 mL in 1 BOTTLE (65862-099-75)

Ingredients (1)

cefprozil (125 mg/5mL)

Linked Drug Pages (1)

Cefprozil ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3c7c4d11-bbf8-4861-add8-0772d41daef5", "openfda": {"nui": ["N0000175488", "M0003827"], "upc": ["0365862099013", "0365862100016"], "unii": ["4W0459ZA4V"], "rxcui": ["309080", "309081"], "spl_set_id": ["97675251-70b8-43bc-93ea-f9ef6bb8cb68"], "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 mL in 1 BOTTLE (65862-099-01)", "package_ndc": "65862-099-01", "marketing_start_date": "20070130"}, {"sample": false, "description": "50 mL in 1 BOTTLE (65862-099-50)", "package_ndc": "65862-099-50", "marketing_start_date": "20070130"}, {"sample": false, "description": "75 mL in 1 BOTTLE (65862-099-75)", "package_ndc": "65862-099-75", "marketing_start_date": "20070130"}], "brand_name": "Cefprozil", "product_id": "65862-099_3c7c4d11-bbf8-4861-add8-0772d41daef5", "dosage_form": "POWDER, FOR SUSPENSION", "product_ndc": "65862-099", "generic_name": "Cefprozil", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cefprozil", "active_ingredients": [{"name": "CEFPROZIL", "strength": "125 mg/5mL"}], "application_number": "ANDA065381", "marketing_category": "ANDA", "marketing_start_date": "20070130", "listing_expiration_date": "20261231"}