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United States · US · US:0009-5182_eeb7c131-8178-44e1-b266-6306dc162a9b

Caverject Impulse

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
    0009518201
    2 SYRINGE in 1 CARTON (0009-5182-01) / .5 mL in 1 SYRINGE (0009-5182-11)

Annotations

UNII (FDA Substance ID)
F5TD010360
ALPROSTADIL
RxCUI 598
Orange Book
N021212
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": "0009-5182_eeb7c131-8178-44e1-b266-6306dc162a9b",
  "productndc": "0009-5182",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "021212",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "0.01MG/VIAL",
        "product_no": "001",
        "approval_date": "Jun 11, 2002"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "0.02MG/VIAL",
        "product_no": "002",
        "approval_date": "Jun 11, 2002"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ALPROSTADIL",
  "proprietary_name": "Caverject Impulse",
  "active_ingred_unit": "ug/.5mL",
  "application_number": "NDA021212",
  "marketing_category": "NDA",
  "nonproprietary_name": "Alprostadil",
  "start_marketing_date": "20020611",
  "active_numerator_strength": "20"
}

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