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United States · US · US:71288-206_7e1975e8-b348-400d-a3aa-9a3ac1cba3b0

Alprostadil

Orange BookUNIISPLATC G04BE01

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

Identification

ManufacturerMeitheal Pharmaceuticals Inc.
CountryUS (United States)
ATC codeG04BE01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7128820602
    10 VIAL, SINGLE-USE in 1 CARTON (71288-206-02) / 1 mL in 1 VIAL, SINGLE-USE (71288-206-01)

Annotations

UNII (FDA Substance ID)
F5TD010360
ALPROSTADIL
RxCUI 598
Orange Book
A075196
AP
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": "INTRAVASCULAR",
  "spl_meta": {
    "35d229e1-6947-435c-bf54-bfa09cca7e53": {
      "match": "brand_token",
      "title": "ALPROSTADIL INJECTION, SOLUTION, CONCENTRATE [MEITHEAL PHARMACEUTICALS INC.]",
      "spl_version": "1",
      "published_date": "2024-09-16"
    }
  },
  "productid": "71288-206_7e1975e8-b348-400d-a3aa-9a3ac1cba3b0",
  "productndc": "71288-206",
  "dosage_form": "INJECTION, SOLUTION, CONCENTRATE",
  "orange_book": {
    "appl_no": "075196",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "0.5MG/ML",
        "product_no": "001",
        "approval_date": "Apr 30, 1999"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ALPROSTADIL",
  "proprietary_name": "Alprostadil",
  "active_ingred_unit": "ug/mL",
  "application_number": "ANDA075196",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Alprostadil",
  "start_marketing_date": "20240915",
  "active_numerator_strength": "500"
}

Related drugs

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