FDA.reportPublic FDA data

Helium

Product NDC
48273-011
11-digit product format
482730011
Labeler code
48273
Product ID
48273-011_43d18b7d-8b63-0f0a-e063-6294a90ad520
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Helium
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
Keen Compressed Gas Co. Inc.
Application
NDA206826
Marketing category
NDA
Marketing start
2019-06-11
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
8bb1e27a-6855-a7c1-e053-2995a90a261eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48273-011-01Helium424.75 L in 1 CYLINDERGAS424.759
48273-011-02Helium707.92 L in 1 CYLINDERGAS707.929
48273-011-03Helium6201.39 L in 1 CYLINDERGAS6201.399
48273-011-04Helium5663.37 L in 1 CYLINDERGAS5663.379
48273-011-05Helium226 L in 1 CYLINDERGAS2269

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48273-011HELIUM GAS [KEEN COMPRESSED GAS CO. INC.]8Current NDC, Legacy NDC, 5 package rows20241012_8bb1e27a-6855-a7c1-e053-2995a90a261e.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HeliumHELIUMHaun Specialty Gases, Inc.5e036b6f-95cf-4c9b-883a-12675015d4752025-12-29Exact identifier
application applno (NDA): 206826
application number: NDA206826
HeliumHELIUMKeen Compressed Gas Co. Inc.8bb1e27a-6855-a7c1-e053-2995a90a261e2025-11-17Exact identifier
application applno (NDA): 206826
application number: NDA206826
ndc (product): 48273-011

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310693helium 99 % Gas for InhalationPSN8bb1e27a-6855-a7c1-e053-2995a90a261e9
310693helium 99 % Gas for InhalationSCD8bb1e27a-6855-a7c1-e053-2995a90a261e9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
48273-011-0148273001101424.75 L in 1 CYLINDER (48273-011-01) 424.75 l2019-06-110000-00-00NoNoCurrent
48273-011-0248273001102707.92 L in 1 CYLINDER (48273-011-02) 707.92 l2019-06-110000-00-00NoNoCurrent
48273-011-03482730011036201.39 L in 1 CYLINDER (48273-011-03) 6201.39 l2019-06-110000-00-00NoNoCurrent
48273-011-04482730011045663.37 L in 1 CYLINDER (48273-011-04) 5663.37 l2019-06-110000-00-00NoNoCurrent
48273-011-0548273001105226 L in 1 CYLINDER (48273-011-05) 226 l2019-06-110000-00-00NoNoCurrent