alprostadil

Generic: alprostadil

Labeler: meitheal pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name alprostadil
Generic Name alprostadil
Labeler meitheal pharmaceuticals inc.
Dosage Form INJECTION, SOLUTION, CONCENTRATE
Routes
INTRAVASCULAR
Active Ingredients

alprostadil 500 ug/mL

Manufacturer
Meitheal Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 71288-206
Product ID 71288-206_7e1975e8-b348-400d-a3aa-9a3ac1cba3b0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075196
Listing Expiration 2026-12-31
Marketing Start 2024-09-15

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 71288206
Hyphenated Format 71288-206

Supplemental Identifiers

RxCUI
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 alprostadil (source: ndc)
Generic Name alprostadil (source: ndc)
Application Number ANDA075196 (source: ndc)
Routes
INTRAVASCULAR
source: ndc

Resolved Composition

Strengths
  • 500 ug/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-USE in 1 CARTON (71288-206-02) / 1 mL in 1 VIAL, SINGLE-USE (71288-206-01)
source: ndc

Packages (1)

71288-206-02 10 VIAL, SINGLE-USE in 1 CARTON (71288-206-02) / 1 mL in 1 VIAL, SINGLE-USE (71288-206-01)

Ingredients (1)

alprostadil (500 ug/mL)

Linked Drug Pages (1)

Alprostadil ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVASCULAR"], "spl_id": "7e1975e8-b348-400d-a3aa-9a3ac1cba3b0", "openfda": {"nui": ["N0000009059", "N0000175454", "N0000180189", "N0000000106", "M0017805", "N0000009911"], "unii": ["F5TD010360"], "rxcui": ["237212"], "spl_set_id": ["35d229e1-6947-435c-bf54-bfa09cca7e53"], "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": ["Meitheal Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-USE in 1 CARTON (71288-206-02)  / 1 mL in 1 VIAL, SINGLE-USE (71288-206-01)", "package_ndc": "71288-206-02", "marketing_start_date": "20240915"}], "brand_name": "Alprostadil", "product_id": "71288-206_7e1975e8-b348-400d-a3aa-9a3ac1cba3b0", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "pharm_class": ["Genitourinary Arterial Vasodilation [PE]", "Prostaglandin Analog [EPC]", "Prostaglandin E1 Agonist [EPC]", "Prostaglandin Receptor Agonists [MoA]", "Prostaglandins [CS]", "Venous Vasodilation [PE]"], "product_ndc": "71288-206", "generic_name": "Alprostadil", "labeler_name": "Meitheal Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Alprostadil", "active_ingredients": [{"name": "ALPROSTADIL", "strength": "500 ug/mL"}], "application_number": "ANDA075196", "marketing_category": "ANDA", "marketing_start_date": "20240915", "listing_expiration_date": "20261231"}