FDA.reportPublic FDA data

HELIUM

Product NDC
42602-002
11-digit product format
426020002
Labeler code
42602
Product ID
42602-002_98d996ba-6551-4cf7-b28d-088a76dcbccf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HELIUM
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
Norco, Inc.
Application
NDA205819
Marketing category
NDA
Marketing start
2008-09-01
Substance
HELIUM
Active strength
99 L/100L
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
HELIUM99 L/100L

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
e1d2805c-1ede-4de5-b06e-f5cffc3ffd3cAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42602-002-01HELIUM595 L in 1 CYLINDERGAS5958
42602-002-02HELIUM6202 L in 1 CYLINDERGAS62028
42602-002-03HELIUM368 L in 1 CYLINDERGAS3688
42602-002-04HELIUM142 L in 1 CYLINDERGAS1428
42602-002-05HELIUM1530 L in 1 CYLINDERGAS15308

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HELIUMACTIVE INGREDIENT206GF3GB41HELIUM GAS [NORCO, INC.]3
HELIUMACTIVE MOIETY206GF3GB41HELIUM GAS [NORCO, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42602-002HELIUM GAS [NORCO, INC.]7Current NDC, Legacy NDC, 5 package rows20240517_e1d2805c-1ede-4de5-b06e-f5cffc3ffd3c.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
HELIUMHELIUMNorco, Inc.e1d2805c-1ede-4de5-b06e-f5cffc3ffd3c2025-08-31Exact identifier
application applno (NDA): 205819
application number: NDA205819
ndc (product): 42602-002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310693helium 99 % Gas for InhalationPSNe1d2805c-1ede-4de5-b06e-f5cffc3ffd3c8
310693helium 99 % Gas for InhalationSCDe1d2805c-1ede-4de5-b06e-f5cffc3ffd3c8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42602-002-0142602000201595 L in 1 CYLINDER (42602-002-01) 595 l2008-09-010000-00-00NoNoCurrent
42602-002-02426020002026202 L in 1 CYLINDER (42602-002-02) 6202 l2008-09-010000-00-00NoNoCurrent
42602-002-0342602000203368 L in 1 CYLINDER (42602-002-03) 368 l2008-09-010000-00-00NoNoCurrent
42602-002-0442602000204142 L in 1 CYLINDER (42602-002-04) 142 l2008-09-010000-00-00NoNoCurrent
42602-002-05426020002051530 L in 1 CYLINDER (42602-002-05) 1530 l2008-09-01NoNoCurrent