prostin vr pediatric

Generic: alprostadil

Labeler: pharmacia & upjohn company llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name prostin vr pediatric
Generic Name alprostadil
Labeler pharmacia & upjohn company llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVASCULAR INTRAVENOUS
Active Ingredients

alprostadil 500 ug/mL

Manufacturer
Pharmacia & Upjohn Company LLC

Identifiers & Regulatory

Product NDC 0009-3169
Product ID 0009-3169_94e421ca-da0e-40dc-bcaf-75f1988c5e55
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA018484
Listing Expiration 2027-12-31
Marketing Start 1981-10-16

Pharmacologic Class

Established (EPC)
prostaglandin analog [epc] prostaglandin e1 agonist [epc]
Mechanism of Action
prostaglandin receptor agonists [moa]
Chemical Structure
prostaglandins [cs]
Physiologic Effect
genitourinary arterial vasodilation [pe] venous vasodilation [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00093169
Hyphenated Format 0009-3169

Supplemental Identifiers

RxCUI
105467 237212
UNII
F5TD010360
NUI
N0000009059 N0000175454 N0000180189 N0000000106 M0017805 N0000009911

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name prostin vr pediatric (source: ndc)
Generic Name alprostadil (source: ndc)
Application Number NDA018484 (source: ndc)
Routes
INTRAVASCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 ug/mL
source: ndc
Packaging
  • 5 AMPULE in 1 PACKAGE (0009-3169-06) / 1 mL in 1 AMPULE (0009-3169-01)
source: ndc

Packages (1)

0009-3169-06 5 AMPULE in 1 PACKAGE (0009-3169-06) / 1 mL in 1 AMPULE (0009-3169-01)

Ingredients (1)

alprostadil (500 ug/mL)

Linked Drug Pages (1)

PROSTIN VR PEDIATRIC ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVASCULAR", "INTRAVENOUS"], "spl_id": "94e421ca-da0e-40dc-bcaf-75f1988c5e55", "openfda": {"nui": ["N0000009059", "N0000175454", "N0000180189", "N0000000106", "M0017805", "N0000009911"], "unii": ["F5TD010360"], "rxcui": ["105467", "237212"], "spl_set_id": ["dea460fa-d05e-4191-8461-f185a711ad89"], "pharm_class_cs": ["Prostaglandins [CS]"], "pharm_class_pe": ["Genitourinary Arterial Vasodilation [PE]", "Venous Vasodilation [PE]"], "pharm_class_epc": ["Prostaglandin Analog [EPC]", "Prostaglandin E1 Agonist [EPC]"], "pharm_class_moa": ["Prostaglandin Receptor Agonists [MoA]"], "manufacturer_name": ["Pharmacia & Upjohn Company LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 AMPULE in 1 PACKAGE (0009-3169-06)  / 1 mL in 1 AMPULE (0009-3169-01)", "package_ndc": "0009-3169-06", "marketing_start_date": "19811016"}], "brand_name": "PROSTIN VR PEDIATRIC", "product_id": "0009-3169_94e421ca-da0e-40dc-bcaf-75f1988c5e55", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Genitourinary Arterial Vasodilation [PE]", "Prostaglandin Analog [EPC]", "Prostaglandin E1 Agonist [EPC]", "Prostaglandin Receptor Agonists [MoA]", "Prostaglandins [CS]", "Venous Vasodilation [PE]"], "product_ndc": "0009-3169", "generic_name": "alprostadil", "labeler_name": "Pharmacia & Upjohn Company LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PROSTIN", "brand_name_suffix": "VR PEDIATRIC", "active_ingredients": [{"name": "ALPROSTADIL", "strength": "500 ug/mL"}], "application_number": "NDA018484", "marketing_category": "NDA", "marketing_start_date": "19811016", "listing_expiration_date": "20271231"}