FDA.reportPublic FDA data

Helium

Product NDC
17575-005
11-digit product format
175750005
Labeler code
17575
Product ID
17575-005_4cc19ab7-134d-fce9-e063-6294a90ac0f5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Helium
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
AGL Inhalation Therapy Co.
Application
NDA205819
Marketing category
NDA
Marketing start
1966-01-01
Substance
HELIUM
Active strength
990 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
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
b309a459-c8bc-4ac3-a4e2-3989a63be8a9Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
17575-005-01helium
17575-005-01helium
17575-005-02helium
17575-005-02helium
17575-005-03helium
17575-005-03helium
17575-005-04helium
17575-005-04helium

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17575-005-01Helium7986 L in 1 CYLINDERGAS798616
17575-005-02Helium589 L in 1 CYLINDERGAS58916
17575-005-03Helium352 L in 1 CYLINDERGAS35216
17575-005-04Helium196 L in 1 CYLINDERGAS19616
17575-005-05Helium4554 L in 1 CYLINDERGAS455416
17575-005-06Helium4690 L in 1 CYLINDERGAS469016

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HeliumACTIVE INGREDIENT206GF3GB41HELIUM GAS [AGL INHALATION THERAPY CO.]1
HeliumACTIVE MOIETY206GF3GB41HELIUM GAS [AGL INHALATION THERAPY CO.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17575-005HELIUM GAS [AGL INHALATION THERAPY CO.]14Current NDC, Legacy NDC, 6 package rows20241012_b309a459-c8bc-4ac3-a4e2-3989a63be8a9.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
HeliumHELIUMAGL Inhalation Therapy Co.b309a459-c8bc-4ac3-a4e2-3989a63be8a92026-03-02Exact identifier
application applno (NDA): 205819
application number: NDA205819
ndc (product): 17575-005
HELIUMHELIUMNorco, Inc.e1d2805c-1ede-4de5-b06e-f5cffc3ffd3c2025-08-31Exact identifier
application applno (NDA): 205819
application number: NDA205819

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310693helium 99 % Gas for InhalationPSNb309a459-c8bc-4ac3-a4e2-3989a63be8a916
310693helium 99 % Gas for InhalationSCDb309a459-c8bc-4ac3-a4e2-3989a63be8a916

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17575-005-01175750005017986 L in 1 CYLINDER (17575-005-01) 7986 l1966-01-010000-00-00NoNoCurrent
17575-005-0217575000502589 L in 1 CYLINDER (17575-005-02) 589 l1966-01-010000-00-00NoNoCurrent
17575-005-0317575000503352 L in 1 CYLINDER (17575-005-03) 352 l1966-01-010000-00-00NoNoCurrent
17575-005-0417575000504196 L in 1 CYLINDER (17575-005-04) 196 l1966-01-010000-00-00NoNoCurrent
17575-005-05175750005054554 L in 1 CYLINDER (17575-005-05) 4554 l1966-01-01NoNoCurrent
17575-005-06175750005064690 L in 1 CYLINDER (17575-005-06) 4690 l1966-01-01NoNoCurrent