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 POWDER, FOR SUSPENSION
Routes
ORAL
Active Ingredients

cefprozil 250 mg/5mL

Manufacturer
NorthStar Rx LLC

Identifiers & Regulatory

Product NDC 16714-397
Product ID 16714-397_f8a7ccea-370c-4afe-92f2-2f4bcc925669
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 16714397
Hyphenated Format 16714-397

Supplemental Identifiers

RxCUI
309080 309081
UPC
0316714396019 0316714397016
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
  • 250 mg/5mL
source: ndc
Packaging
  • 50 mL in 1 BOTTLE (16714-397-01)
  • 75 mL in 1 BOTTLE (16714-397-02)
  • 100 mL in 1 BOTTLE (16714-397-03)
source: ndc

Packages (3)

16714-397-01 50 mL in 1 BOTTLE (16714-397-01) 16714-397-02 75 mL in 1 BOTTLE (16714-397-02) 16714-397-03 100 mL in 1 BOTTLE (16714-397-03)

Ingredients (1)

cefprozil (250 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": "f8a7ccea-370c-4afe-92f2-2f4bcc925669", "openfda": {"nui": ["N0000175488", "M0003827"], "upc": ["0316714396019", "0316714397016"], "unii": ["4W0459ZA4V"], "rxcui": ["309080", "309081"], "spl_set_id": ["8e3943b5-8c30-4c81-bcfa-aeaaa1d75fb4"], "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 mL in 1 BOTTLE (16714-397-01)", "package_ndc": "16714-397-01", "marketing_start_date": "20070130"}, {"sample": false, "description": "75 mL in 1 BOTTLE (16714-397-02)", "package_ndc": "16714-397-02", "marketing_start_date": "20070130"}, {"sample": false, "description": "100 mL in 1 BOTTLE (16714-397-03)", "package_ndc": "16714-397-03", "marketing_start_date": "20070130"}], "brand_name": "Cefprozil", "product_id": "16714-397_f8a7ccea-370c-4afe-92f2-2f4bcc925669", "dosage_form": "POWDER, FOR SUSPENSION", "product_ndc": "16714-397", "generic_name": "Cefprozil", "labeler_name": "NorthStar Rx LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cefprozil", "active_ingredients": [{"name": "CEFPROZIL", "strength": "250 mg/5mL"}], "application_number": "ANDA065381", "marketing_category": "ANDA", "marketing_start_date": "20070130", "listing_expiration_date": "20261231"}