FDA.reportPublic FDA data

Helium

Product NDC
59579-005
Requested package NDC
59579-005-18
11-digit product format
595790005
Labeler code
59579
Product ID
59579-005_730acade-2aba-489a-a393-752220f3bb0f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Helium
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
Linde Gas & Equipment Inc.
Application
NDA205912
Marketing category
NDA
Marketing start
2007-12-01
Substance
HELIUM
Active strength
990 mL/L
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
206GF3GB41Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310693Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
bf6e56a4-0193-4436-ae0d-cb0f0f65c2fcAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59579-005-01Helium14696 L in 1 CYLINDERGAS1469611
59579-005-02Helium12233 L in 1 CYLINDERGAS1223311
59579-005-03Helium9430 L in 1 CYLINDERGAS943011
59579-005-04Helium8240 L in 1 CYLINDERGAS824011
59579-005-05Helium6909 L in 1 CYLINDERGAS690911
59579-005-06Helium6173 L in 1 CYLINDERGAS617311
59579-005-07Helium3823 L in 1 CYLINDERGAS382311
59579-005-08Helium3087 L in 1 CYLINDERGAS308711
59579-005-09Helium2067 L in 1 CYLINDERGAS206711
59579-005-10Helium1048 L in 1 CYLINDERGAS104811
59579-005-11Helium623 L in 1 CYLINDERGAS62311
59579-005-12Helium510 L in 1 CYLINDERGAS51011
59579-005-13Helium538 L in 1 CYLINDERGAS53811
59579-005-14Helium142 L in 1 CYLINDERGAS14211
59579-005-15Helium368 L in 1 CYLINDERGAS36811
59579-005-16Helium113 L in 1 CYLINDERGAS11311
59579-005-17Helium170 L in 1 CYLINDERGAS17011
59579-005-18Helium6768 L in 1 CYLINDERGAS676811
59579-005-19Helium2209 L in 1 CYLINDERGAS220911
59579-005-20Helium821 L in 1 CYLINDERGAS82111
59579-005-21Helium99 L in 1 CYLINDERGAS9911
59579-005-22Helium99 L in 1 CYLINDERGAS9911
59579-005-23Helium57 L in 1 CYLINDERGAS5711
59579-005-24Helium3820 L in 1 CYLINDERGAS382011
59579-005-25Helium396 L in 1 CYLINDERGAS39611
59579-005-26Helium1444 L in 1 CYLINDERGAS144411

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HeliumACTIVE INGREDIENT206GF3GB41HELIUM GAS [PRAXAIR DISTRIBUTION, INC.]3
HeliumACTIVE MOIETY206GF3GB41HELIUM GAS [PRAXAIR DISTRIBUTION, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59579-005HELIUM GAS [LINDE GAS & EQUIPMENT INC.]11Current NDC, Legacy NDC, 26 package rows20250130_bf6e56a4-0193-4436-ae0d-cb0f0f65c2fc.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HeliumHELIUMLinde Gas & Equipment Inc.bf6e56a4-0193-4436-ae0d-cb0f0f65c2fc2025-01-15Exact identifier
application applno (NDA): 205912
application number: NDA205912
ndc (package): 59579-005-18
ndc (product): 59579-005
ndc11 (package): 59579000518

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310693helium 99 % Gas for InhalationPSNbf6e56a4-0193-4436-ae0d-cb0f0f65c2fc11
310693helium 99 % Gas for InhalationSCDbf6e56a4-0193-4436-ae0d-cb0f0f65c2fc11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59579-005-18595790005186768 L in 1 CYLINDER (59579-005-18) 6768 l2007-12-010000-00-00NoNoCurrent