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United States · US · US:16714-394_518e9779-a683-436e-a032-c6a0df0a0de2

CEFPODOXIME PROXETIL

Orange BookUNIISPLATC J01DD

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

Identification

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

Packs · 1

  • ndc11
    1671439401
    20 TABLET, FILM COATED in 1 BOTTLE (16714-394-01)

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": "16714-394_518e9779-a683-436e-a032-c6a0df0a0de2",
  "productndc": "16714-394",
  "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": "100"
}

Related drugs

Other records sharing ATC code J01DD.

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