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United States · US · US:68180-402_45d1a412-407b-48d4-be64-b9c7ec3c5205

CEFPROZIL

Orange BookUNIISPLATC J01DC

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

Identification

ManufacturerLupin Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeJ01DC
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    6818040201
    50 mL in 1 BOTTLE (68180-402-01)
  • ndc11
    6818040202
    75 mL in 1 BOTTLE (68180-402-02)
  • ndc11
    6818040203
    100 mL in 1 BOTTLE (68180-402-03)

Annotations

UNII (FDA Substance ID)
4W0459ZA4V
CEFPROZIL
RxCUI 19552
Orange Book
A065261
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": "68180-402_45d1a412-407b-48d4-be64-b9c7ec3c5205",
  "productndc": "68180-402",
  "dosage_form": "POWDER, FOR SUSPENSION",
  "orange_book": {
    "appl_no": "065261",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "125MG/5ML",
        "product_no": "001",
        "approval_date": "Dec 19, 2005"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG/5ML",
        "product_no": "002",
        "approval_date": "Dec 19, 2005"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CEFPROZIL",
  "proprietary_name": "CEFPROZIL",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA065261",
  "marketing_category": "ANDA",
  "nonproprietary_name": "CEFPROZIL",
  "start_marketing_date": "20051201",
  "active_numerator_strength": "250"
}

Related drugs

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