FDA.reportPublic FDA data

Helium

Product NDC
21220-200
11-digit product format
212200200
Labeler code
21220
Product ID
21220-200_44876bc6-87c9-bdd7-e063-6394a90a30e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Helium
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
General Air Service & Supply Co
Application
NDA216307
Marketing category
NDA
Marketing start
1958-01-01
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.

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
eb561a7a-9c50-3660-e053-2a95a90a97e9Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21220-200-01Helium6201 L in 1 CYLINDERGAS62015
21220-200-02Helium250 L in 1 CYLINDERGAS2505
21220-200-03Helium623 L in 1 CYLINDERGAS6235

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21220-200HELIUM GAS [GENERAL AIR SERVICE & SUPPLY CO]4Current NDC, Legacy NDC, 3 package rows20241030_eb561a7a-9c50-3660-e053-2a95a90a97e9.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
HeliumHELIUMGeneral Air Service & Supply Coeb561a7a-9c50-3660-e053-2a95a90a97e92025-11-26Exact identifier
application applno (NDA): 216307
application number: NDA216307
ndc (product): 21220-200

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310693helium 99 % Gas for InhalationPSNeb561a7a-9c50-3660-e053-2a95a90a97e95
310693helium 99 % Gas for InhalationSCDeb561a7a-9c50-3660-e053-2a95a90a97e95

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21220-200-01212200200016201 L in 1 CYLINDER (21220-200-01) 6201 l1958-01-010000-00-00NoNoCurrent
21220-200-0221220020002250 L in 1 CYLINDER (21220-200-02) 250 l1958-01-010000-00-00NoNoCurrent
21220-200-0321220020003623 L in 1 CYLINDER (21220-200-03) 623 l1958-01-01NoNoCurrent