ulspira

Generic: ulspira

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

Drug Facts

Product Profile

Brand Name ulspira
Generic Name ulspira
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 82605-006
Product ID 82605-006_3a136eac-7cc3-31ea-e063-6294a90afb91
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 82605006
Hyphenated Format 82605-006

Supplemental Identifiers

RxCUI
582608
UPC
0082605006021 0082605006014
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 ulspira (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 (82605-006-01)
  • 362 L in 1 CYLINDER (82605-006-02)
source: ndc

Packages (2)

82605-006-01 2138 L in 1 CYLINDER (82605-006-01) 82605-006-02 362 L in 1 CYLINDER (82605-006-02)

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": "3a136eac-7cc3-31ea-e063-6294a90afb91", "openfda": {"nui": ["N0000009909", "N0000175940"], "upc": ["0082605006021", "0082605006014"], "unii": ["31C4KY9ESH"], "rxcui": ["582608"], "spl_set_id": ["026e4541-63fa-aebc-e063-6294a90abaea"], "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 (82605-006-01)", "package_ndc": "82605-006-01", "marketing_start_date": "20230804"}, {"sample": false, "description": "362 L in 1 CYLINDER (82605-006-02)", "package_ndc": "82605-006-02", "marketing_start_date": "20230804"}], "brand_name": "Ulspira", "product_id": "82605-006_3a136eac-7cc3-31ea-e063-6294a90afb91", "dosage_form": "GAS", "pharm_class": ["Vasodilation [PE]", "Vasodilator [EPC]"], "product_ndc": "82605-006", "generic_name": "Ulspira", "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"}