PODOFILOX

In shortageOrange BookUNIISPLATC D06BB04

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerPadagis US LLC

CountryUS (United States)

ATC codeD06BB04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0574061105
1 BOTTLE, GLASS in 1 CARTON (0574-0611-05) / 3.5 mL in 1 BOTTLE, GLASS

Annotations

UNII (FDA Substance ID)

L36H50F353

PODOFILOX

RxCUI 8463

Orange Book

A075600

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Podofilox Topical Gel

Raw payload (JSON)

{
  "unii": {
    "unii": "L36H50F353",
    "rxcui": "8463",
    "inchikey": "YJGVMLPVUAXIQN-XVVDYKMHSA-N",
    "display_name": "PODOFILOX",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "TOPICAL",
  "spl_meta": {
    "6af07697-5203-43e0-ba35-83683af851c3": {
      "match": "brand_token",
      "title": "PODOFILOX SOLUTION [PADAGIS US LLC]",
      "spl_version": "9",
      "published_date": "2024-03-12"
    }
  },
  "productid": "0574-0611_e75d3f9f-dd11-4c3e-9e6e-3d9af2cd76da",
  "productndc": "0574-0611",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "075600",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "0.5%",
        "product_no": "001",
        "approval_date": "Jan 29, 2002"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PODOFILOX",
  "shortage_reason": "Podofilox Topical Gel",
  "shortage_status": "current",
  "proprietary_name": "PODOFILOX",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA075600",
  "marketing_category": "ANDA",
  "nonproprietary_name": "PODOFILOX",
  "start_marketing_date": "20020129",
  "active_numerator_strength": "5"
}

Related drugs

Other records sharing ATC code D06BB04.

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