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United States · US · US:16714-396_f8a7ccea-370c-4afe-92f2-2f4bcc925669

Cefprozil

Orange BookUNIISPLATC J01DC

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerNorthStar Rx LLC
CountryUS (United States)
ATC codeJ01DC
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    1671439602
    75 mL in 1 BOTTLE (16714-396-02)
  • ndc11
    1671439603
    100 mL in 1 BOTTLE (16714-396-03)

Annotations

UNII (FDA Substance ID)
4W0459ZA4V
CEFPROZIL
RxCUI 19552
Orange Book
A065381
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "4W0459ZA4V",
    "rxcui": "19552",
    "inchikey": null,
    "display_name": "CEFPROZIL",
    "substance_type": "mixture",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "800a2ec0-4798-4423-9613-d03024cf1f0e": {
      "match": "brand_token",
      "title": "CEFPROZIL POWDER, FOR SUSPENSION [LUPIN PHARMACEUTICALS, INC.]",
      "spl_version": "1",
      "published_date": "2026-05-06"
    }
  },
  "productid": "16714-396_f8a7ccea-370c-4afe-92f2-2f4bcc925669",
  "productndc": "16714-396",
  "dosage_form": "POWDER, FOR SUSPENSION",
  "orange_book": {
    "appl_no": "065381",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "125MG/5ML",
        "product_no": "001",
        "approval_date": "Jan 30, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG/5ML",
        "product_no": "002",
        "approval_date": "Jan 30, 2007"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CEFPROZIL",
  "proprietary_name": "Cefprozil",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA065381",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cefprozil",
  "start_marketing_date": "20070130",
  "active_numerator_strength": "125"
}

Related drugs

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