FDA.reportPublic FDA data

Helium

Product NDC
12213-710
11-digit product format
122130710
Labeler code
12213
Product ID
12213-710_4279510c-94a2-86a7-e063-6394a90ab2e6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Helium
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
NexAir, LLC
Application
NDA209033
Marketing category
NDA
Marketing start
1996-06-01
Substance
HELIUM
Active strength
999 mL/L
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Helium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HELIUM999 mL/L

Harmonized Identifiers#

Field, Values table
FieldValues
Unii206GF3GB41
Rxcui347675

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12213-710-12Helium6145 L in 1 CYLINDERGAS614585
12213-710-13Helium408 L in 1 CYLINDERGAS40885
12213-710-20Helium6201 L in 1 CYLINDERGAS620185
12213-710-21Helium8240 L in 1 CYLINDERGAS824085
12213-710-22Helium1019 L in 1 CYLINDERGAS101985
12213-710-40Helium425 L in 1 CYLINDERGAS42585
12213-710-50Helium2067 L in 1 CYLINDERGAS206785
12213-710-58Helium586 L in 1 CYLINDERGAS58685
12213-710-60Helium113 L in 1 CYLINDERGAS11385

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HeliumACTIVE INGREDIENT206GF3GB41HELIUM GAS [NEXAIR, LLC]7
HeliumACTIVE MOIETY206GF3GB41HELIUM GAS [NEXAIR, LLC]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12213-710HELIUM GAS [NEXAIR, LLC]20Current NDC, Legacy NDC, 9 package rows20241114_cb33fc07-e122-4f66-aa43-b659ee150150.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
347675helium 99.9 % Gas for InhalationPSNcb33fc07-e122-4f66-aa43-b659ee15015085
347675helium 99.9 % Gas for InhalationSCDcb33fc07-e122-4f66-aa43-b659ee15015085

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
12213-710-12122130710126145 L in 1 CYLINDER (12213-710-12) 6145 l1996-06-010000-00-00NoNoCurrent
12213-710-1312213071013408 L in 1 CYLINDER (12213-710-13) 408 l1996-06-010000-00-00NoNoCurrent
12213-710-20122130710206201 L in 1 CYLINDER (12213-710-20) 6201 l1996-06-010000-00-00NoNoCurrent
12213-710-21122130710218240 L in 1 CYLINDER (12213-710-21) 8240 l1996-06-010000-00-00NoNoCurrent
12213-710-22122130710221019 L in 1 CYLINDER (12213-710-22) 1019 l1996-06-010000-00-00NoNoCurrent
12213-710-4012213071040425 L in 1 CYLINDER (12213-710-40) 425 l1996-06-010000-00-00NoNoCurrent
12213-710-50122130710502067 L in 1 CYLINDER (12213-710-50) 2067 l1996-06-010000-00-00NoNoCurrent
12213-710-5812213071058586 L in 1 CYLINDER (12213-710-58) 586 l1996-06-010000-00-00NoNoCurrent
12213-710-6012213071060113 L in 1 CYLINDER (12213-710-60) 113 l1996-06-010000-00-00NoNoCurrent