FDA.reportPublic FDA data

Reconstituted Air

Product NDC
68877-009
11-digit product format
688770009
Labeler code
68877
Product ID
68877-009_40bda564-ab0e-fbaf-e063-6294a90ab1e0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Reconstituted Air
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
United States Cylinder Gas Corporation
Application
NDA205849
Marketing category
NDA
Marketing start
2025-10-01
Substance
OXYGEN
Active strength
210 mL/L
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Reconstituted Air
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYGEN210 mL/L

Harmonized Identifiers#

Field, Values table
FieldValues
UniiS88TT14065
Rxcui347856

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68877-009-01Reconstituted Air1133 L in 1 CYLINDERGAS11331
68877-009-02Reconstituted Air3069 L in 1 CYLINDERGAS30691
68877-009-03Reconstituted Air6139 L in 1 CYLINDERGAS61391
68877-009-04Reconstituted Air8145 L in 1 CYLINDERGAS81451

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
347856oxygen 21 % Gas for InhalationPSN40bda564-ab0d-fbaf-e063-6294a90ab1e01
347856oxygen 21 % Gas for InhalationSCD40bda564-ab0d-fbaf-e063-6294a90ab1e01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68877-009-01688770009011133 L in 1 CYLINDER (68877-009-01) 1133 l2025-10-01NoNoCurrent
68877-009-02688770009023069 L in 1 CYLINDER (68877-009-02) 3069 l2025-10-01NoNoCurrent
68877-009-03688770009036139 L in 1 CYLINDER (68877-009-03) 6139 l2025-10-01NoNoCurrent
68877-009-04688770009048145 L in 1 CYLINDER (68877-009-04) 8145 l2025-10-01NoNoCurrent