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United States · US · US:16714-403_3c3d4973-bfda-476f-b094-52ac4648d7f8

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 · 2

  • ndc11
    1671440301
    1 BOTTLE in 1 CARTON (16714-403-01) / 50 mL in 1 BOTTLE
  • ndc11
    1671440302
    1 BOTTLE in 1 CARTON (16714-403-02) / 100 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
2TB00A1Z7N
CEFPODOXIME PROXETIL
RxCUI 47835
Orange Book
A065409
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": "16714-403_3c3d4973-bfda-476f-b094-52ac4648d7f8",
  "productndc": "16714-403",
  "dosage_form": "GRANULE, FOR SUSPENSION",
  "orange_book": {
    "appl_no": "065409",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 50MG BASE/5ML",
        "product_no": "001",
        "approval_date": "Jun 8, 2007"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "EQ 100MG BASE/5ML",
        "product_no": "002",
        "approval_date": "Jun 8, 2007"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CEFPODOXIME PROXETIL",
  "proprietary_name": "Cefpodoxime Proxetil",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA065409",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cefpodoxime Proxetil",
  "start_marketing_date": "20070608",
  "active_numerator_strength": "100"
}

Related drugs

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