FDA.reportPublic FDA data

Helium

Product NDC
84120-001
11-digit product format
841200001
Labeler code
84120
Product ID
84120-001_40a9f139-f16f-bb51-e063-6294a90a5536
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Helium
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
WSM SUPPLIER LLC.
Application
NDA205843
Marketing category
NDA
Marketing start
2024-05-07
Substance
HELIUM
Active strength
992 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
HELIUM992 mL/L

Harmonized Identifiers#

Field, Values table
FieldValues
Unii206GF3GB41
Rxcui997972

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84120-001-01Helium377 L in 1 CYLINDERGAS3773
84120-001-02Helium623 L in 1 CYLINDERGAS6233
84120-001-03Helium2143 L in 1 CYLINDERGAS21433
84120-001-04Helium2899 L in 1 CYLINDERGAS28993
84120-001-05Helium5689 L in 1 CYLINDERGAS56893
84120-001-06Helium6201 L in 1 CYLINDERGAS62013
84120-001-07Helium6338 L in 1 CYLINDERGAS63383
84120-001-08Helium6824 L in 1 CYLINDERGAS68243
84120-001-09Helium7481 L in 1 CYLINDERGAS74813
84120-001-10Helium8144 L in 1 CYLINDERGAS81443
84120-001-11Helium762 L in 1 CYLINDERGAS7623

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84120-001HELIUM GAS [WSM SUPPLIER LLC.]2Current NDC, 11 package rows20241204_153317bb-7f55-0964-e063-6394a90a2922.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
997972helium 99.2 % Gas for InhalationPSN153317bb-7f55-0964-e063-6394a90a29223
997972helium 99.2 % Gas for InhalationSCD153317bb-7f55-0964-e063-6394a90a29223

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84120-001-0184120000101377 L in 1 CYLINDER (84120-001-01) 377 l2024-05-07NoNoCurrent
84120-001-0284120000102623 L in 1 CYLINDER (84120-001-02) 623 l2024-05-07NoNoCurrent
84120-001-03841200001032143 L in 1 CYLINDER (84120-001-03) 2143 l2024-05-07NoNoCurrent
84120-001-04841200001042899 L in 1 CYLINDER (84120-001-04) 2899 l2024-05-07NoNoCurrent
84120-001-05841200001055689 L in 1 CYLINDER (84120-001-05) 5689 l2024-05-07NoNoCurrent
84120-001-06841200001066201 L in 1 CYLINDER (84120-001-06) 6201 l2024-05-07NoNoCurrent
84120-001-07841200001076338 L in 1 CYLINDER (84120-001-07) 6338 l2024-05-07NoNoCurrent
84120-001-08841200001086824 L in 1 CYLINDER (84120-001-08) 6824 l2024-05-07NoNoCurrent
84120-001-09841200001097481 L in 1 CYLINDER (84120-001-09) 7481 l2024-05-07NoNoCurrent
84120-001-10841200001108144 L in 1 CYLINDER (84120-001-10) 8144 l2024-05-07NoNoCurrent
84120-001-1184120000111762 L in 1 CYLINDER (84120-001-11) 762 l2024-05-07NoNoCurrent