FDA.reportPublic FDA data

Helium

Product NDC
12213-710
11-digit product format
122130710
Labeler code
12213
Product ID
12213-710_4279510c-94a2-86a7-e063-6394a90ab2e6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Helium
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
NexAir, LLC
Application
NDA209033
Marketing category
NDA
Marketing start
1996-06-01
Substance
HELIUM
Active strength
999 mL/L
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog.

Additional Listing Data#

Finished product
Yes
Brand name base
Helium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HELIUM999 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
347675Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
cb33fc07-e122-4f66-aa43-b659ee150150Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12213-710-12Helium6145 L in 1 CYLINDERGAS614585
12213-710-13Helium408 L in 1 CYLINDERGAS40885
12213-710-20Helium6201 L in 1 CYLINDERGAS620185
12213-710-21Helium8240 L in 1 CYLINDERGAS824085
12213-710-22Helium1019 L in 1 CYLINDERGAS101985
12213-710-40Helium425 L in 1 CYLINDERGAS42585
12213-710-50Helium2067 L in 1 CYLINDERGAS206785
12213-710-58Helium586 L in 1 CYLINDERGAS58685
12213-710-60Helium113 L in 1 CYLINDERGAS11385

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HeliumACTIVE INGREDIENT206GF3GB41HELIUM GAS [NEXAIR, LLC]7
HeliumACTIVE MOIETY206GF3GB41HELIUM GAS [NEXAIR, LLC]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12213-710HELIUM GAS [NEXAIR, LLC]20Current NDC, Legacy NDC, 9 package rows20241114_cb33fc07-e122-4f66-aa43-b659ee150150.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
HeliumHELIUMNexAir, LLCcb33fc07-e122-4f66-aa43-b659ee1501502026-05-22Exact identifier
application applno (NDA): 209033
application number: NDA209033
ndc (product): 12213-710

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
347675helium 99.9 % Gas for InhalationPSNcb33fc07-e122-4f66-aa43-b659ee15015085
347675helium 99.9 % Gas for InhalationSCDcb33fc07-e122-4f66-aa43-b659ee15015085

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
12213-710-12122130710126145 L in 1 CYLINDER (12213-710-12) 6145 l1996-06-010000-00-00NoNoCurrent
12213-710-1312213071013408 L in 1 CYLINDER (12213-710-13) 408 l1996-06-010000-00-00NoNoCurrent
12213-710-20122130710206201 L in 1 CYLINDER (12213-710-20) 6201 l1996-06-010000-00-00NoNoCurrent
12213-710-21122130710218240 L in 1 CYLINDER (12213-710-21) 8240 l1996-06-010000-00-00NoNoCurrent
12213-710-22122130710221019 L in 1 CYLINDER (12213-710-22) 1019 l1996-06-010000-00-00NoNoCurrent
12213-710-4012213071040425 L in 1 CYLINDER (12213-710-40) 425 l1996-06-010000-00-00NoNoCurrent
12213-710-50122130710502067 L in 1 CYLINDER (12213-710-50) 2067 l1996-06-010000-00-00NoNoCurrent
12213-710-5812213071058586 L in 1 CYLINDER (12213-710-58) 586 l1996-06-010000-00-00NoNoCurrent
12213-710-6012213071060113 L in 1 CYLINDER (12213-710-60) 113 l1996-06-010000-00-00NoNoCurrent