Edex

Orange BookUNIISPLATC G04BE01

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

Identification

ManufacturerEndo USA, Inc.

CountryUS (United States)

ATC codeG04BE01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
5224401002
2 BLISTER PACK in 1 CARTON (52244-010-02) / 1 CARTRIDGE in 1 BLISTER PACK / 1 mL in 1 CARTRIDGE (52244-010-01)
ndc11
5224401006
6 BLISTER PACK in 1 CARTON (52244-010-06) / 1 CARTRIDGE in 1 BLISTER PACK / 1 mL in 1 CARTRIDGE (52244-010-01)

Annotations

UNII (FDA Substance ID)

F5TD010360

ALPROSTADIL

RxCUI 598

Orange Book

N020649

APAPAP

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "F5TD010360",
    "rxcui": "598",
    "inchikey": "GMVPRGQOIOIIMI-DWKJAMRDSA-N",
    "display_name": "ALPROSTADIL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRACAVERNOUS",
  "spl_meta": {
    "e8b8ec8d-1318-43e4-a182-446e9f9579de": {
      "match": "brand_token",
      "title": "EDEX (ALPROSTADIL) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ENDO USA, INC.]",
      "spl_version": "16",
      "published_date": "2026-05-21"
    }
  },
  "productid": "52244-010_66cf008c-1361-4fd1-8e5c-3e95981f8a76",
  "productndc": "52244-010",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "020649",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "0.005MG/VIAL",
        "product_no": "001",
        "approval_date": "Jun 12, 1997"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AP",
        "strength": "0.01MG/VIAL",
        "product_no": "002",
        "approval_date": "Jun 12, 1997"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AP",
        "strength": "0.02MG/VIAL",
        "product_no": "003",
        "approval_date": "Jun 12, 1997"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "0.04MG/VIAL",
        "product_no": "004",
        "approval_date": "Jun 12, 1997"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.01MG/VIAL",
        "product_no": "005",
        "approval_date": "Jul 30, 1998"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.02MG/VIAL",
        "product_no": "006",
        "approval_date": "Jul 30, 1998"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.04MG/VIAL",
        "product_no": "007",
        "approval_date": "Jul 30, 1998"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ALPROSTADIL",
  "proprietary_name": "Edex",
  "active_ingred_unit": "ug/mL",
  "application_number": "NDA020649",
  "marketing_category": "NDA",
  "nonproprietary_name": "alprostadil",
  "start_marketing_date": "20120415",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code G04BE01.

Access this data programmatically

Query Edex and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs