PROSTIN
Prostin VR Pediatric alprostadil injection, USP
Approved
Approval ID
dea460fa-d05e-4191-8461-f185a711ad89
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 8, 2020
Manufacturers
FDA
Pharmacia and Upjohn Company LLC
DUNS: 618054084
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
alprostadil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0009-3169
Application NumberNDA018484
Product Classification
M
Marketing Category
C73594
G
Generic Name
alprostadil
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAVASCULAR
Effective DateMay 8, 2020
FDA Product Classification
INGREDIENTS (2)
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
ALPROSTADILActive
Quantity: 500 ug in 1 mL
Code: F5TD010360
Classification: ACTIB