caverject impulse

Generic: alprostadil

Labeler: u.s. pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name caverject impulse
Generic Name alprostadil
Labeler u.s. pharmaceuticals
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRACAVERNOUS
Active Ingredients

alprostadil 20 ug/.5mL

Manufacturer
U.S. Pharmaceuticals

Identifiers & Regulatory

Product NDC 63539-221
Product ID 63539-221_e742118b-48b5-4262-9efb-dbc4bd08aec8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021212
Listing Expiration 2026-12-31
Marketing Start 2014-05-04

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 63539221
Hyphenated Format 63539-221

Supplemental Identifiers

RxCUI
763470 763472 763473 763474
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 caverject impulse (source: ndc)
Generic Name alprostadil (source: ndc)
Application Number NDA021212 (source: ndc)
Routes
INTRACAVERNOUS
source: ndc

Resolved Composition

Strengths
  • 20 ug/.5mL
source: ndc
Packaging
  • 2 SYRINGE in 1 CARTON (63539-221-21) / .5 mL in 1 SYRINGE (63539-221-20)
source: ndc

Packages (1)

63539-221-21 2 SYRINGE in 1 CARTON (63539-221-21) / .5 mL in 1 SYRINGE (63539-221-20)

Ingredients (1)

alprostadil (20 ug/.5mL)

Linked Drug Pages (1)

Caverject Impulse ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRACAVERNOUS"], "spl_id": "e742118b-48b5-4262-9efb-dbc4bd08aec8", "openfda": {"nui": ["N0000009059", "N0000175454", "N0000180189", "N0000000106", "M0017805", "N0000009911"], "unii": ["F5TD010360"], "rxcui": ["763470", "763472", "763473", "763474"], "spl_set_id": ["d8f85a7e-becb-4e15-9829-40e8f359140a"], "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": ["U.S. Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 SYRINGE in 1 CARTON (63539-221-21)  / .5 mL in 1 SYRINGE (63539-221-20)", "package_ndc": "63539-221-21", "marketing_start_date": "20140504"}], "brand_name": "Caverject Impulse", "product_id": "63539-221_e742118b-48b5-4262-9efb-dbc4bd08aec8", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR 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": "63539-221", "generic_name": "Alprostadil", "labeler_name": "U.S. Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Caverject Impulse", "active_ingredients": [{"name": "ALPROSTADIL", "strength": "20 ug/.5mL"}], "application_number": "NDA021212", "marketing_category": "NDA", "marketing_start_date": "20140504", "listing_expiration_date": "20261231"}