FDA.reportPublic FDA data

Helium

Product NDC
46123-800
11-digit product format
461230800
Labeler code
46123
Product ID
46123-800_43cecff0-1ded-dece-e063-6394a90a8c6e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Helium
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
Roberts Oxygen Company, Inc.
Application
NDA213609
Marketing category
NDA
Marketing start
1967-01-01
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
46123-800-01Helium102 L in 1 CYLINDERGAS1027
46123-800-02Helium374 L in 1 CYLINDERGAS3747
46123-800-03Helium623 L in 1 CYLINDERGAS6237
46123-800-04Helium3880 L in 1 CYLINDERGAS38807
46123-800-05Helium5436 L in 1 CYLINDERGAS54367
46123-800-06Helium6910 L in 1 CYLINDERGAS69107
46123-800-07Helium8241 L in 1 CYLINDERGAS82417

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HeliumACTIVE INGREDIENT206GF3GB41HELIUM GAS [ROBERTS OXYGEN COMPANY, INC.]1
HeliumACTIVE MOIETY206GF3GB41HELIUM GAS [ROBERTS OXYGEN COMPANY, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46123-800HELIUM GAS [ROBERTS OXYGEN COMPANY, INC.]6Current NDC, 7 package rows20250122_554faa48-7fc2-4d1a-b223-82cf107b144f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310693helium 99 % Gas for InhalationPSN554faa48-7fc2-4d1a-b223-82cf107b144f7
310693helium 99 % Gas for InhalationSCD554faa48-7fc2-4d1a-b223-82cf107b144f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
46123-800-0146123080001102 L in 1 CYLINDER (46123-800-01) 102 l1967-01-01NoNoCurrent
46123-800-0246123080002374 L in 1 CYLINDER (46123-800-02) 374 l1967-01-01NoNoCurrent
46123-800-0346123080003623 L in 1 CYLINDER (46123-800-03) 623 l1967-01-01NoNoCurrent
46123-800-04461230800043880 L in 1 CYLINDER (46123-800-04) 3880 l1967-01-01NoNoCurrent
46123-800-05461230800055436 L in 1 CYLINDER (46123-800-05) 5436 l1967-01-01NoNoCurrent
46123-800-06461230800066910 L in 1 CYLINDER (46123-800-06) 6910 l1967-01-01NoNoCurrent
46123-800-07461230800078241 L in 1 CYLINDER (46123-800-07) 8241 l1967-01-01NoNoCurrent