Ulspira

Product NDC
82605-006
11-digit product format
826050006
Labeler code
82605
Product ID
82605-006_3a136eac-7cc3-31ea-e063-6294a90afb91
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ulspira
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
Airgas Therapeutics, LLC
Application
ANDA203144
Marketing category
ANDA
Marketing start
2023-08-04
Substance
NITRIC OXIDE
Active strength
.8 mL/100L
Pharmacologic classes
Vasodilation [PE], Vasodilator [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ulspira
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NITRIC OXIDE.8 mL/100L

Harmonized Identifiers#

Field, Values table
FieldValues
Unii31C4KY9ESH
Rxcui582608

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
46e64ad7-7dca-4816-a2a4-8cdff2136105Product name220240828

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82605-006-01Ulspira2138 L in 1 CYLINDERGAS213832
82605-006-02Ulspira362 L in 1 CYLINDERGAS36232

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
582608nitric oxide 800 PPM Gas for InhalationPSN026e4541-63fa-aebc-e063-6294a90abaea32
582608nitric oxide 0.08 % / nitrogen 99.92 % Gas for InhalationSCD026e4541-63fa-aebc-e063-6294a90abaea32
582608nitric oxide 800 PPM Gas for InhalationSY026e4541-63fa-aebc-e063-6294a90abaea32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82605-006-01826050006012138 L in 1 CYLINDER (82605-006-01) 2138 l2023-08-04NoNoCurrent
82605-006-0282605000602362 L in 1 CYLINDER (82605-006-02) 362 l2023-08-04NoNoCurrent