FDA.reportPublic FDA data

Helium

Product NDC
14961-005
11-digit product format
149610005
Labeler code
14961
Product ID
14961-005_471b4709-87ae-bd9d-e063-6394a90a4933
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Helium
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
Haun Specialty Gases, Inc.
Application
NDA206826
Marketing category
NDA
Marketing start
2005-01-04
Substance
HELIUM
Active strength
990 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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HELIUM990 mL/L

Harmonized Identifiers#

Field, Values table
FieldValues
Unii206GF3GB41
Rxcui310693

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
14961-005-01Helium73 L in 1 CYLINDERGAS7315
14961-005-02Helium344 L in 1 CYLINDERGAS34415
14961-005-03Helium589 L in 1 CYLINDERGAS58915

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14961-005HELIUM GAS [HAUN SPECIALTY GASES, INC.]14Current NDC, Legacy NDC, 3 package rows20241027_5e036b6f-95cf-4c9b-883a-12675015d475.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310693helium 99 % Gas for InhalationPSN5e036b6f-95cf-4c9b-883a-12675015d47515
310693helium 99 % Gas for InhalationSCD5e036b6f-95cf-4c9b-883a-12675015d47515

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
14961-005-011496100050173 L in 1 CYLINDER (14961-005-01) 73 l2005-01-040000-00-00NoNoCurrent
14961-005-0214961000502344 L in 1 CYLINDER (14961-005-02) 344 l2005-01-040000-00-00NoNoCurrent
14961-005-0314961000503589 L in 1 CYLINDER (14961-005-03) 589 l2005-01-040000-00-00NoNoCurrent