FDA.reportPublic FDA data

RECONSTITUTED AIR

Product NDC
84078-004
11-digit product format
840780004
Labeler code
84078
Product ID
84078-004_497829cf-edda-eb06-e063-6394a90a80e4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
RECONSTITUTED AIR
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
WELDERS SUPPLY COMPANY OF LOUISVILLE, INC.
Application
NDA205889
Marketing category
NDA
Marketing start
2026-01-26
Substance
OXYGEN
Active strength
210 mL/L
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
RECONSTITUTED AIR
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYGEN210 mL/L

Harmonized Identifiers#

Field, Values table
FieldValues
UniiS88TT14065
Rxcui347123

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84078-004-01RECONSTITUTED AIR663 L in 1 CYLINDERGAS6631
84078-004-02RECONSTITUTED AIR6029 L in 1 CYLINDERGAS60291

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
347123nitrogen 79 % / oxygen 21 % Gas for InhalationPSN497829cf-edd9-eb06-e063-6394a90a80e41
347123nitrogen 79 % / oxygen 21 % Gas for InhalationSCD497829cf-edd9-eb06-e063-6394a90a80e41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84078-004-0184078000401663 L in 1 CYLINDER (84078-004-01) 663 l2026-01-26NoNoCurrent
84078-004-02840780004026029 L in 1 CYLINDER (84078-004-02) 6029 l2026-01-26NoNoCurrent