FDA.reportPublic FDA data

HELIUM

Product NDC
10167-300
11-digit product format
101670300
Labeler code
10167
Product ID
10167-300_bbffc3c2-c49f-4215-8e74-0a2e7a92e3cd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HELIUM
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
Air Source Industries Inc
Application
NDA205843
Marketing category
NDA
Marketing start
1992-01-01
Substance
HELIUM
Active strength
99 L/100L
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
HELIUM99 L/100L

Harmonized Identifiers#

Field, Values table
FieldValues
Unii206GF3GB41
Rxcui310693

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10167-300-01HELIUM610 L in 1 CYLINDERGAS61012
10167-300-02HELIUM5800 L in 1 CYLINDERGAS580012
10167-300-03HELIUM6160 L in 1 CYLINDERGAS616012
10167-300-04HELIUM161 L in 1 CYLINDERGAS16112
10167-300-05HELIUM166 L in 1 CYLINDERGAS16612
10167-300-06HELIUM370 L in 1 CYLINDERGAS37012
10167-300-07HELIUM2780 L in 1 CYLINDERGAS278012
10167-300-08HELIUM1557 L in 1 CYLINDERGAS155712

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10167-300HELIUM GAS [AIR SOURCE INDUSTRIES INC]12Current NDC, Legacy NDC, 8 package rows20241008_7d1d5963-8b7f-4d8d-807a-6b9f896c7171.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310693helium 99 % Gas for InhalationPSN7d1d5963-8b7f-4d8d-807a-6b9f896c717112
310693helium 99 % Gas for InhalationSCD7d1d5963-8b7f-4d8d-807a-6b9f896c717112

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10167-300-0110167030001610 L in 1 CYLINDER (10167-300-01) 610 l1992-01-010000-00-00NoNoCurrent
10167-300-02101670300025800 L in 1 CYLINDER (10167-300-02) 5800 l1992-01-010000-00-00NoNoCurrent
10167-300-03101670300036160 L in 1 CYLINDER (10167-300-03) 6160 l1992-01-010000-00-00NoNoCurrent
10167-300-0410167030004161 L in 1 CYLINDER (10167-300-04) 161 l1992-01-010000-00-00NoNoCurrent
10167-300-0510167030005166 L in 1 CYLINDER (10167-300-05) 166 l1992-01-010000-00-00NoNoCurrent
10167-300-0610167030006370 L in 1 CYLINDER (10167-300-06) 370 l1992-01-010000-00-00NoNoCurrent
10167-300-07101670300072780 L in 1 CYLINDER (10167-300-07) 2780 l1992-01-010000-00-00NoNoCurrent
10167-300-08101670300081557 L in 1 CYLINDER (10167-300-08) 1557 l1992-01-010000-00-00NoNoCurrent