cefprozil

Generic: cefprozil

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cefprozil
Generic Name cefprozil
Labeler rising pharma holdings, inc.
Dosage Form POWDER, FOR SUSPENSION
Routes
ORAL
Active Ingredients

cefprozil 125 mg/5mL

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 57237-034
Product ID 57237-034_2288a04a-b86b-4c3b-8e12-e61531cf5b43
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 57237034
Hyphenated Format 57237-034

Supplemental Identifiers

RxCUI
309080 309081
UPC
0357237035504
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 (57237-034-01)
  • 50 mL in 1 BOTTLE (57237-034-50)
  • 75 mL in 1 BOTTLE (57237-034-75)
source: ndc

Packages (3)

57237-034-01 100 mL in 1 BOTTLE (57237-034-01) 57237-034-50 50 mL in 1 BOTTLE (57237-034-50) 57237-034-75 75 mL in 1 BOTTLE (57237-034-75)

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": "2288a04a-b86b-4c3b-8e12-e61531cf5b43", "openfda": {"nui": ["N0000175488", "M0003827"], "upc": ["0357237035504"], "unii": ["4W0459ZA4V"], "rxcui": ["309080", "309081"], "spl_set_id": ["d7fac9cc-30e1-4762-a01b-04f1bd3b2a56"], "pharm_class_cs": ["Cephalosporins [CS]"], "pharm_class_epc": ["Cephalosporin Antibacterial [EPC]"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 mL in 1 BOTTLE (57237-034-01)", "package_ndc": "57237-034-01", "marketing_start_date": "20070130"}, {"sample": false, "description": "50 mL in 1 BOTTLE (57237-034-50)", "package_ndc": "57237-034-50", "marketing_start_date": "20070130"}, {"sample": false, "description": "75 mL in 1 BOTTLE (57237-034-75)", "package_ndc": "57237-034-75", "marketing_start_date": "20070130"}], "brand_name": "Cefprozil", "product_id": "57237-034_2288a04a-b86b-4c3b-8e12-e61531cf5b43", "dosage_form": "POWDER, FOR SUSPENSION", "product_ndc": "57237-034", "generic_name": "Cefprozil", "labeler_name": "Rising Pharma Holdings, Inc.", "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"}