FDA.reportPublic FDA data

Helium/Oxygen Mix

Product NDC
12213-801
11-digit product format
122130801
Labeler code
12213
Product ID
12213-801_4279490a-a12b-05d4-e063-6394a90afa67
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Helium/Oxygen Mix
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
NEXAIR, LLC
Application
NDA205849
Marketing category
NDA
Marketing start
1996-06-01
Substance
OXYGEN
Active strength
200 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 Mix
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYGEN200 mL/L

Harmonized Identifiers#

Field, Values table
FieldValues
UniiS88TT14065
Rxcui413101

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12213-801-01Helium/Oxygen Mix5987.5 L in 1 CYLINDERGAS5987.510
12213-801-02Helium/Oxygen Mix5774 L in 1 CYLINDERGAS577410
12213-801-03Helium/Oxygen Mix6201 L in 1 CYLINDERGAS620110
12213-801-04Helium/Oxygen Mix586 L in 1 CYLINDERGAS58610
12213-801-05Helium/Oxygen Mix5856 L in 1 CYLINDERGAS585610
12213-801-06Helium/Oxygen Mix5938 L in 1 CYLINDERGAS593810
12213-801-12Helium/Oxygen Mix5663 L in 1 CYLINDERGAS566310
12213-801-13Helium/Oxygen Mix382 L in 1 CYLINDERGAS38210
12213-801-28Helium/Oxygen Mix561 L in 1 CYLINDERGAS56110

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12213-801HELIUM/OXYGEN MIX GAS [NEXAIR, LLC]9Current NDC, Legacy NDC, 9 package rows20241114_60dd4f4b-7132-385e-e053-2a91aa0ad5d6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
413101oxygen 20 % Gas for InhalationPSN60dd4f4b-7132-385e-e053-2a91aa0ad5d610
413101oxygen 20 % Gas for InhalationSCD60dd4f4b-7132-385e-e053-2a91aa0ad5d610
413101nitrogen (inactive) 80 % / oxygen 20 % Gas for InhalationSY60dd4f4b-7132-385e-e053-2a91aa0ad5d610

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
12213-801-01122130801015987.5 L in 1 CYLINDER (12213-801-01) 5987.5 l1996-06-010000-00-00NoNoCurrent
12213-801-02122130801025774 L in 1 CYLINDER (12213-801-02) 5774 l1996-06-010000-00-00NoNoCurrent
12213-801-03122130801036201 L in 1 CYLINDER (12213-801-03) 6201 l1996-06-010000-00-00NoNoCurrent
12213-801-0412213080104586 L in 1 CYLINDER (12213-801-04) 586 l1996-06-010000-00-00NoNoCurrent
12213-801-05122130801055856 L in 1 CYLINDER (12213-801-05) 5856 l1996-06-010000-00-00NoNoCurrent
12213-801-06122130801065938 L in 1 CYLINDER (12213-801-06) 5938 l1996-06-010000-00-00NoNoCurrent
12213-801-12122130801125663 L in 1 CYLINDER (12213-801-12) 5663 l1996-06-010000-00-00NoNoCurrent
12213-801-1312213080113382 L in 1 CYLINDER (12213-801-13) 382 l1996-06-010000-00-00NoNoCurrent
12213-801-2812213080128561 L in 1 CYLINDER (12213-801-28) 561 l1996-06-010000-00-00NoNoCurrent