FDA.reportPublic FDA data

Carbogen

Product NDC
53440-008
Requested package NDC
53440-008-07
11-digit product format
534400008
Labeler code
53440
Product ID
53440-008_5dd2917c-df54-b8bc-e063-6394a90a463c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbogen
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
Westair Gases & Equipment, Inc.
Application
NDA205767
Marketing category
NDA
Marketing start
2000-01-01
Substance
OXYGEN
Active strength
950 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
Carbogen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYGEN950 mL/L

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53440-008-04Carbogen33984 L in 1 CYLINDERGAS3398410
53440-008-05Carbogen8496 L in 1 CYLINDERGAS849610
53440-008-06Carbogen5664 L in 1 CYLINDERGAS566410
53440-008-07Carbogen2832 L in 1 CYLINDERGAS283210
53440-008-08Carbogen2266 L in 1 CYLINDERGAS226610
53440-008-09Carbogen1416 L in 1 CYLINDERGAS141610
53440-008-10Carbogen708 L in 1 CYLINDERGAS70810
53440-008-11Carbogen425 L in 1 CYLINDERGAS42510
53440-008-12Carbogen255 L in 1 CYLINDERGAS25510
53440-008-13Carbogen170 L in 1 CYLINDERGAS17010
53440-008-14Carbogen113 L in 1 CYLINDERGAS11310
53440-008-15Carbogen57 L in 1 CYLINDERGAS5710

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53440-008CARBOGEN GAS [WESTAIR GASES & EQUIPMENT, INC.]9Current NDC, Legacy NDC, 12 package rows20241204_60e0fb73-0329-5e30-e053-2a91aa0ae779.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
53440-008-07534400008072832 L in 1 CYLINDER (53440-008-07) 2832 l2000-01-010000-00-00NoNoCurrent