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United States · US · US:69292-516_157c18ee-7809-4e05-8caa-0359ef50142e

Cefpodoxime Proxetil

Orange BookUNIISPLATC J01DD

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

Identification

ManufacturerAmici Pharmaceuticals, LLC.
CountryUS (United States)
ATC codeJ01DD
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6929251601
    100 TABLET, FILM COATED in 1 BOTTLE (69292-516-01)
  • ndc11
    6929251650
    500 TABLET, FILM COATED in 1 BOTTLE (69292-516-50)

Annotations

UNII (FDA Substance ID)
2TB00A1Z7N
CEFPODOXIME PROXETIL
RxCUI 47835
Orange Book
A210568
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": "69292-516_157c18ee-7809-4e05-8caa-0359ef50142e",
  "productndc": "69292-516",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "210568",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 100MG BASE",
        "product_no": "001",
        "approval_date": "May 18, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 200MG BASE",
        "product_no": "002",
        "approval_date": "May 18, 2022"
      }
    ],
    "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": "ANDA210568",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cefpodoxime Proxetil",
  "start_marketing_date": "20221221",
  "active_numerator_strength": "200"
}

Related drugs

Other records sharing ATC code J01DD.

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