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United States · US · US:69043-007_36f0759f-b50b-4a49-869b-d73f5ad7d8cf

CEFPODOXIME PROXETIL

Orange BookUNIISPLATC J01DD

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

Identification

ManufacturerCronus Pharma LLC
CountryUS (United States)
ATC codeJ01DD
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6904300701
    100 TABLET, FILM COATED in 1 BOTTLE (69043-007-01)
  • ndc11
    6904300725
    250 TABLET, FILM COATED in 1 BOTTLE (69043-007-25)

Annotations

UNII (FDA Substance ID)
2TB00A1Z7N
CEFPODOXIME PROXETIL
RxCUI 47835
Orange Book
A065370
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": "69043-007_36f0759f-b50b-4a49-869b-d73f5ad7d8cf",
  "productndc": "69043-007",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "065370",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 100MG BASE",
        "product_no": "001",
        "approval_date": "Jun 11, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 200MG BASE",
        "product_no": "002",
        "approval_date": "Jun 11, 2007"
      }
    ],
    "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": "ANDA065370",
  "marketing_category": "ANDA",
  "nonproprietary_name": "CEFPODOXIME PROXETIL",
  "start_marketing_date": "20070611",
  "active_numerator_strength": "200"
}

Related drugs

Other records sharing ATC code J01DD.

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