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United States · US · US:0009-7686_c9c81920-1b63-4318-9cc1-38cc4d3fa601

Caverject

Orange BookUNIISPLATC G04BE01

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

Identification

ManufacturerPharmacia & Upjohn Company LLC
CountryUS (United States)
ATC codeG04BE01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0009768604
    6 VIAL, SINGLE-DOSE in 1 PACKAGE (0009-7686-04) / 1 mL in 1 VIAL, SINGLE-DOSE (0009-7686-01)

Annotations

UNII (FDA Substance ID)
F5TD010360
ALPROSTADIL
RxCUI 598
Orange Book
N020379
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": {
    "a295fc1e-d82c-4f44-bc2d-a552bf594c98": {
      "match": "brand_token",
      "title": "CAVERJECT (ALPROSTADIL) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PHARMACIA & UPJOHN COMPANY LLC]",
      "spl_version": "19",
      "published_date": "2024-05-17"
    }
  },
  "productid": "0009-7686_c9c81920-1b63-4318-9cc1-38cc4d3fa601",
  "productndc": "0009-7686",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "020379",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AP",
        "strength": "0.01MG/VIAL",
        "product_no": "001",
        "approval_date": "Jul 6, 1995"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "0.02MG/VIAL",
        "product_no": "002",
        "approval_date": "Jul 6, 1995"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "0.005MG/VIAL",
        "product_no": "003",
        "approval_date": "Jun 27, 1996"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "0.04MG/VIAL",
        "product_no": "004",
        "approval_date": "May 19, 1997"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ALPROSTADIL",
  "proprietary_name": "Caverject",
  "active_ingred_unit": "ug/mL",
  "application_number": "NDA020379",
  "marketing_category": "NDA",
  "nonproprietary_name": "Alprostadil",
  "start_marketing_date": "19950706",
  "active_numerator_strength": "41.1"
}

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