FDA.reportPublic FDA data

Helium

Product NDC
51486-020
11-digit product format
514860020
Labeler code
51486
Product ID
51486-020_424c9c8a-5805-0b5d-e063-6294a90ad8d2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Helium
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
ILMO Products Company
Application
NDA213990
Marketing category
NDA
Marketing start
2019-09-02
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
9aefb755-268a-1d8b-e053-2a95a90a1df7Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51486-020-01Helium144.4 L in 1 CYLINDERGAS144.49
51486-020-02Helium623 L in 1 CYLINDERGAS6239
51486-020-03Helium3201.39 L in 1 CYLINDERGAS3201.399
51486-020-04Helium957 L in 1 CYLINDERGAS9579
51486-020-05Helium5689 L in 1 CYLINDERGAS56899

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51486-020HELIUM GAS [ILMO PRODUCTS COMPANY]8Current NDC, Legacy NDC, 5 package rows20250406_9aefb755-268a-1d8b-e053-2a95a90a1df7.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
HeliumHELIUMILMO Products Company9aefb755-268a-1d8b-e053-2a95a90a1df72025-10-29Exact identifier
application applno (NDA): 213990
application number: NDA213990
ndc (product): 51486-020

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310693helium 99 % Gas for InhalationPSN9aefb755-268a-1d8b-e053-2a95a90a1df79
310693helium 99 % Gas for InhalationSCD9aefb755-268a-1d8b-e053-2a95a90a1df79

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51486-020-0151486002001144.4 L in 1 CYLINDER (51486-020-01) 144.4 l2019-09-020000-00-00NoNoCurrent
51486-020-0251486002002623 L in 1 CYLINDER (51486-020-02) 623 l2019-09-020000-00-00NoNoCurrent
51486-020-03514860020033201.39 L in 1 CYLINDER (51486-020-03) 3201.39 l2019-09-020000-00-00NoNoCurrent
51486-020-0451486002004957 L in 1 CYLINDER (51486-020-04) 957 l2019-09-020000-00-00NoNoCurrent
51486-020-05514860020055689 L in 1 CYLINDER (51486-020-05) 5689 l2019-09-02NoNoCurrent