FDA.reportPublic FDA data

RECONSTITUTED AIR

Product NDC
84120-005
11-digit product format
841200005
Labeler code
84120
Product ID
84120-005_40d3cfb2-9110-7949-e063-6394a90af65b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
RECONSTITUTED AIR
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
WSM SUPPLIER LLC.
Application
NDA205889
Marketing category
NDA
Marketing start
2024-05-07
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
Rxcui347123

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84120-005-01RECONSTITUTED AIR408 L in 1 CYLINDERGAS4083
84120-005-02RECONSTITUTED AIR665 L in 1 CYLINDERGAS6653
84120-005-03RECONSTITUTED AIR2305 L in 1 CYLINDERGAS23053
84120-005-04RECONSTITUTED AIR2608 L in 1 CYLINDERGAS26083
84120-005-05RECONSTITUTED AIR3030 L in 1 CYLINDERGAS30303
84120-005-06RECONSTITUTED AIR3092.2 L in 1 CYLINDERGAS3092.23
84120-005-07RECONSTITUTED AIR5376 L in 1 CYLINDERGAS53763
84120-005-08RECONSTITUTED AIR5912 L in 1 CYLINDERGAS59123
84120-005-09RECONSTITUTED AIR6032 L in 1 CYLINDERGAS60323
84120-005-10RECONSTITUTED AIR6598 L in 1 CYLINDERGAS65983
84120-005-11RECONSTITUTED AIR6739 L in 1 CYLINDERGAS67393
84120-005-12RECONSTITUTED AIR7334 L in 1 CYLINDERGAS73343
84120-005-13RECONSTITUTED AIR8070 L in 1 CYLINDERGAS80703
84120-005-14RECONSTITUTED AIR8807 L in 1 CYLINDERGAS88073

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84120-005RECONSTITUTED AIR GAS [WSM SUPPLIER LLC.]2Current NDC, 14 package rows20241204_17e3afd9-e900-1d44-e063-6294a90a0472.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
347123nitrogen 79 % / oxygen 21 % Gas for InhalationPSN17e3afd9-e900-1d44-e063-6294a90a04723
347123nitrogen 79 % / oxygen 21 % Gas for InhalationSCD17e3afd9-e900-1d44-e063-6294a90a04723

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84120-005-0184120000501408 L in 1 CYLINDER (84120-005-01) 408 l2024-05-07NoNoCurrent
84120-005-0284120000502665 L in 1 CYLINDER (84120-005-02) 665 l2024-05-07NoNoCurrent
84120-005-03841200005032305 L in 1 CYLINDER (84120-005-03) 2305 l2024-05-07NoNoCurrent
84120-005-04841200005042608 L in 1 CYLINDER (84120-005-04) 2608 l2024-05-07NoNoCurrent
84120-005-05841200005053030 L in 1 CYLINDER (84120-005-05) 3030 l2024-05-07NoNoCurrent
84120-005-06841200005063092.2 L in 1 CYLINDER (84120-005-06) 3092.2 l2024-05-07NoNoCurrent
84120-005-07841200005075376 L in 1 CYLINDER (84120-005-07) 5376 l2024-05-07NoNoCurrent
84120-005-08841200005085912 L in 1 CYLINDER (84120-005-08) 5912 l2024-05-07NoNoCurrent
84120-005-09841200005096032 L in 1 CYLINDER (84120-005-09) 6032 l2024-05-07NoNoCurrent
84120-005-10841200005106598 L in 1 CYLINDER (84120-005-10) 6598 l2024-05-07NoNoCurrent
84120-005-11841200005116739 L in 1 CYLINDER (84120-005-11) 6739 l2024-05-07NoNoCurrent
84120-005-12841200005127334 L in 1 CYLINDER (84120-005-12) 7334 l2024-05-07NoNoCurrent
84120-005-13841200005138070 L in 1 CYLINDER (84120-005-13) 8070 l2024-05-07NoNoCurrent
84120-005-14841200005148807 L in 1 CYLINDER (84120-005-14) 8807 l2024-05-07NoNoCurrent