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United States · US · US:0781-5438_6878b572-5711-43a8-9972-1410927f1f14

Cefpodoxime Proxetil

Orange BookUNIISPLATC J01DD

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

Identification

ManufacturerSandoz Inc
CountryUS (United States)
ATC codeJ01DD
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0781543801
    100 TABLET, FILM COATED in 1 BOTTLE (0781-5438-01)
  • ndc11
    0781543820
    20 TABLET, FILM COATED in 1 BOTTLE (0781-5438-20)

Annotations

UNII (FDA Substance ID)
2TB00A1Z7N
CEFPODOXIME PROXETIL
RxCUI 47835
Orange Book
A065462
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "2TB00A1Z7N",
    "rxcui": "47835",
    "inchikey": "LTINZAODLRIQIX-FBXRGJNPSA-N",
    "display_name": "CEFPODOXIME PROXETIL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "ca125f98-0ea7-43c3-9861-9dada1efef45": {
      "match": "brand_token",
      "title": "CEFPODOXIME PROXETIL POWDER [AX PHARMACEUTICAL CORP]",
      "spl_version": "5",
      "published_date": "2026-05-11"
    }
  },
  "productid": "0781-5438_6878b572-5711-43a8-9972-1410927f1f14",
  "productndc": "0781-5438",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "065462",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 100MG BASE",
        "product_no": "001",
        "approval_date": "May 28, 2008"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 200MG BASE",
        "product_no": "002",
        "approval_date": "May 28, 2008"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CEFPODOXIME PROXETIL",
  "proprietary_name": "Cefpodoxime Proxetil",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA065462",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cefpodoxime Proxetil",
  "start_marketing_date": "20080528",
  "active_numerator_strength": "100"
}

Related drugs

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