FDA.reportPublic FDA data

Helium Oxygen mixture

Product NDC
11054-032
11-digit product format
110540032
Labeler code
11054
Product ID
11054-032_bb74f93c-30bd-4d5c-9663-cc4c840b9dbf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Helium Oxygen mixture
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
Airgas Usa, LLC
Application
NDA205843
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2012-01-03
Substance
HELIUM; OXYGEN
Active strength
700; 300 mL/L; mL/L
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Helium Oxygen mixture
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HELIUM700 mL/L
OXYGEN300 mL/L

Harmonized Identifiers#

Field, Values table
FieldValues
Unii206GF3GB41, S88TT14065
Rxcui347048

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11054-032-01Helium Oxygen mixture3539 L in 1 CYLINDERGAS35398
11054-032-02Helium Oxygen mixture5663 L in 1 CYLINDERGAS56638

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11054-032HELIUM OXYGEN MIXTURE GAS [AIRGAS USA, LLC]8Current NDC, Legacy NDC, 2 package rows20241004_df74ce02-cbf4-49b3-8456-dc4fa7ddc9be.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
347048helium 70 % / oxygen 30 % Gas for InhalationPSNdf74ce02-cbf4-49b3-8456-dc4fa7ddc9be8
347048helium 70 % / oxygen 30 % Gas for InhalationSCDdf74ce02-cbf4-49b3-8456-dc4fa7ddc9be8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11054-032-01110540032013539 L in 1 CYLINDER (11054-032-01) 3539 l2012-01-030000-00-00NoNoCurrent
11054-032-02110540032025663 L in 1 CYLINDER (11054-032-02) 5663 l2012-01-030000-00-00NoNoCurrent