FDA.reportPublic FDA data

Oxygen Helium Mixture 30/70

Product NDC
17575-038
11-digit product format
175750038
Labeler code
17575
Product ID
17575-038_41c36c29-c24c-b53a-e063-6294a90a180a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxygen Helium Mixture 30/70
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
AGL Inhalation Therapy Co.
Application
NDA205767
Marketing category
NDA
Marketing start
1966-01-01
Substance
OXYGEN
Active strength
300 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.

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
Oxygen Helium Mixture 30/70
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYGEN300 mL/L

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
S88TT14065Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3c799e75-d974-4f9d-bd47-0ffbd05b8b98Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17575-038-012026-01-29C16284748780-149896155-a733-586f-e063-e6dba90add90oxygen helium 30/70
17575-038-022026-01-29C16284748780-149896155-a733-586f-e063-e6dba90add90oxygen helium 30/70
17575-038-032026-01-29C16284748780-149896155-a733-586f-e063-e6dba90add90oxygen helium 30/70

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17575-038-01Oxygen Helium Mixture 30/704690 L in 1 CYLINDERGAS469013
17575-038-02Oxygen Helium Mixture 30/70515 L in 1 CYLINDERGAS51513
17575-038-03Oxygen Helium Mixture 30/704910 L in 1 CYLINDERGAS491013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17575-038OXYGEN HELIUM MIXTURE 30/70 GAS [AGL INHALATION THERAPY CO.]12Current NDC, Legacy NDC, 3 package rows20241012_3c799e75-d974-4f9d-bd47-0ffbd05b8b98.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 5 of 5 · 82 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OXYGENOXYGENNoble Gas Solutions, Inc.13ce9fe8-ca43-4564-87b2-f8e97570dcfd2024-10-06Exact identifier
application applno (NDA): 205767
application number: NDA205767
OxygenOXYGENADF Welding & Medical, Inc.01efe36d-5281-4ede-bc30-9a1727a86a832024-10-02Exact identifier
application applno (NDA): 205767
application number: NDA205767

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17575-038-01175750038014690 L in 1 CYLINDER (17575-038-01) 4690 l1966-01-010000-00-00NoNoCurrent
17575-038-0217575003802515 L in 1 CYLINDER (17575-038-02) 515 l1966-01-010000-00-00NoNoCurrent
17575-038-03175750038034910 L in 1 CYLINDER (17575-038-03) 4910 l1966-01-010000-00-00NoNoCurrent