🇺🇸
United States · US · US:0009-0215_86df82a7-5bba-4292-b34c-032daa818e45
PROSTIN
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
- ndc1100090215055 AMPULE in 1 PACKAGE (0009-0215-05) / 1 mL in 1 AMPULE (0009-0215-01)
Annotations
UNII (FDA Substance ID)
F5TD010360
ALPROSTADIL
RxCUI 598
Orange Book
N018484
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; INTRAVENOUS",
"spl_meta": {
"dea460fa-d05e-4191-8461-f185a711ad89": {
"match": "brand_token",
"title": "PROSTIN VR PEDIATRIC (ALPROSTADIL) INJECTION, SOLUTION [PHARMACIA & UPJOHN COMPANY LLC]",
"spl_version": "11",
"published_date": "2026-05-21"
}
},
"productid": "0009-0215_86df82a7-5bba-4292-b34c-032daa818e45",
"productndc": "0009-0215",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "018484",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AP",
"strength": "0.5MG/ML",
"product_no": "001",
"approval_date": "Approved Prior to Jan 1, 1982"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "ALPROSTADIL",
"proprietary_name": "PROSTIN",
"active_ingred_unit": "ug/mL",
"application_number": "NDA018484",
"marketing_category": "NDA",
"nonproprietary_name": "alprostadil",
"start_marketing_date": "20221003",
"active_numerator_strength": "500"
}Related drugs
Other records sharing ATC code G04BE01.
- NOAlprostadil2care4 ApS
- 🇺🇸AlprostadilMeitheal Pharmaceuticals Inc.
- DKAlprostadil "2care4"2care4 ApS
- GBAlprostadil 10microgram powder and solvent for solution for injection vialsPfizer Ltd
- GBAlprostadil 20microgram powder and solvent for solution for injection vialsPfizer Ltd
- 🇪🇸ALPROSTADIL ALTAN 20 MICROGRAMOS POLVO PARA SOLUCION PARA PERFUSION EFGAltan Pharmaceuticals S.A.
- 🇫🇷ALPROSTADIL INTSEL CHIMOS 0,5 mg/ml, solution injectableINTSEL CHIMOS
- 🇪🇸ALPROSTADIL PFIZER 0,5 mg/ml SOLUCION INYECTABLEPfizer S.L.
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