ulspira

Generic: nitric oxide

Labeler: airgas therapeutics, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ulspira
Generic Name nitric oxide
Labeler airgas therapeutics, llc
Dosage Form GAS
Routes
RESPIRATORY (INHALATION)
Active Ingredients

nitric oxide .8 mL/100L

Manufacturer
Airgas Therapeutics, LLC

Identifiers & Regulatory

Product NDC 82605-008
Product ID 82605-008_42659119-4ca6-acf0-e063-6294a90a52ee
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203144
Listing Expiration 2026-12-31
Marketing Start 2023-08-04

Pharmacologic Class

Established (EPC)
vasodilator [epc]
Physiologic Effect
vasodilation [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82605008
Hyphenated Format 82605-008

Supplemental Identifiers

RxCUI
582608 2702871
UNII
31C4KY9ESH
NUI
N0000009909 N0000175940

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 ulspira (source: ndc)
Generic Name nitric oxide (source: ndc)
Application Number ANDA203144 (source: ndc)
Routes
RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • .8 mL/100L
source: ndc
Packaging
  • 2138 L in 1 CYLINDER (82605-008-01)
  • 362 L in 1 CYLINDER (82605-008-02)
source: ndc

Packages (2)

82605-008-01 2138 L in 1 CYLINDER (82605-008-01) 82605-008-02 362 L in 1 CYLINDER (82605-008-02)

Ingredients (1)

nitric oxide (.8 mL/100L)

Linked Drug Pages (1)

Ulspira ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["RESPIRATORY (INHALATION)"], "spl_id": "42659119-4ca6-acf0-e063-6294a90a52ee", "openfda": {"nui": ["N0000009909", "N0000175940"], "unii": ["31C4KY9ESH"], "rxcui": ["582608", "2702871"], "spl_set_id": ["2c605fc0-82be-09e0-e063-6394a90a63e9"], "pharm_class_pe": ["Vasodilation [PE]"], "pharm_class_epc": ["Vasodilator [EPC]"], "manufacturer_name": ["Airgas Therapeutics, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2138 L in 1 CYLINDER (82605-008-01)", "package_ndc": "82605-008-01", "marketing_start_date": "20230804"}, {"sample": false, "description": "362 L in 1 CYLINDER (82605-008-02)", "package_ndc": "82605-008-02", "marketing_start_date": "20230804"}], "brand_name": "Ulspira", "product_id": "82605-008_42659119-4ca6-acf0-e063-6294a90a52ee", "dosage_form": "GAS", "pharm_class": ["Vasodilation [PE]", "Vasodilator [EPC]"], "product_ndc": "82605-008", "generic_name": "Nitric Oxide", "labeler_name": "Airgas Therapeutics, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ulspira", "active_ingredients": [{"name": "NITRIC OXIDE", "strength": ".8 mL/100L"}], "application_number": "ANDA203144", "marketing_category": "ANDA", "marketing_start_date": "20230804", "listing_expiration_date": "20261231"}