FDA.reportPublic FDA data

Helium

Product NDC
49575-200
11-digit product format
495750200
Labeler code
49575
Product ID
49575-200_44ff0133-984c-f57e-e063-6294a90a5c73
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Helium
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
Machine & Welding Supply Company dba Arc3 Gases South
Application
NDA211781
Marketing category
NDA
Marketing start
2022-02-01
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
49575-200-06Helium99.5 L in 1 CYLINDERGAS99.51
49575-200-07Helium144.4 L in 1 CYLINDERGAS144.41
49575-200-08Helium377 L in 1 CYLINDERGAS3771
49575-200-09Helium623 L in 1 CYLINDERGAS6231

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310693helium 99 % Gas for InhalationPSN44ff03e6-f79d-eb6c-e063-6294a90aba5b1
310693helium 99 % Gas for InhalationSCD44ff03e6-f79d-eb6c-e063-6294a90aba5b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
49575-200-064957502000699.5 L in 1 CYLINDER (49575-200-06) 99.5 l2022-02-01NoNoCurrent
49575-200-0749575020007144.4 L in 1 CYLINDER (49575-200-07) 144.4 l2022-02-01NoNoCurrent
49575-200-0849575020008377 L in 1 CYLINDER (49575-200-08) 377 l2022-02-01NoNoCurrent
49575-200-0949575020009623 L in 1 CYLINDER (49575-200-09) 623 l2022-02-01NoNoCurrent