Back to search
🇺🇸

United States · US · US:65862-068_6397ff45-3c37-40c3-a924-d036bb896b3b

Cefprozil

Orange BookUNIISPLATC J01DC

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

Identification

ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeJ01DC
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    6586206801
    100 TABLET, FILM COATED in 1 BOTTLE (65862-068-01)
  • ndc11
    6586206805
    500 TABLET, FILM COATED in 1 BOTTLE (65862-068-05)
  • ndc11
    6586206830
    30 TABLET, FILM COATED in 1 BOTTLE (65862-068-30)
  • ndc11
    6586206850
    50 TABLET, FILM COATED in 1 BOTTLE (65862-068-50)

Annotations

UNII (FDA Substance ID)
4W0459ZA4V
CEFPROZIL
RxCUI 19552
Orange Book
A065340
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": "65862-068_6397ff45-3c37-40c3-a924-d036bb896b3b",
  "productndc": "65862-068",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "065340",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "001",
        "approval_date": "May 24, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "500MG",
        "product_no": "002",
        "approval_date": "May 24, 2007"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CEFPROZIL",
  "proprietary_name": "Cefprozil",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA065340",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cefprozil",
  "start_marketing_date": "20070524",
  "active_numerator_strength": "250"
}

Related drugs

Other records sharing ATC code J01DC.

Access this data programmatically

Query Cefprozil and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.