RECONSTITUTED AIR

Product NDC
84078-004
Requested package NDC
84078-004-01
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

Source provenance: Browse the complete Orange Book source catalog.

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
347123Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
497829cf-edd9-eb06-e063-6394a90a80e4Available on FDA.report

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

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 1 of 3 · 49 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OxygenOXYGENWELDERS SUPPLY COMPANY OF LOUISVILLE, INC.1017fba9-0472-88cf-e063-6294a90afe1c2026-04-28Exact identifier
application applno (NDA): 205889
application number: NDA205889
OxygenOXYGENMITCHELL WELDING SUPPLY DBA Meritus Texas704755e8-239d-18d6-e053-2991aa0ab7d22026-03-24Exact identifier
application applno (NDA): 205889
application number: NDA205889
OxygenOXYGENMatheson Tri-Gas, Inc.d7c5336e-3afe-2763-e053-2a95a90ae78f2026-03-13Exact identifier
application applno (NDA): 205889
application number: NDA205889
RECONSTITUTED AIRRECONSTITUTED AIRWELDERS SUPPLY COMPANY OF LOUISVILLE, INC.497829cf-edd9-eb06-e063-6394a90a80e42026-01-28Exact identifier
application applno (NDA): 205889
application number: NDA205889
ndc (package): 84078-004-01
ndc (product): 84078-004
ndc11 (package): 84078000401
OXYGENOXYGENCorrigan Propane LLC dba Blue Water Industrial Productseed9ed38-3eba-4aac-b2e8-fbfaa4549dba2026-01-25Exact identifier
application applno (NDA): 205889
application number: NDA205889
OxygenOXYGENPlains Welding Supply, Inc.0bfa29ff-cac6-40b5-880d-6cbf13a50c512025-12-28Exact identifier
application applno (NDA): 205889
application number: NDA205889
OxygenOXYGENHelget Gas Productsf791c94b-7fba-3857-e053-6294a90ac6be2025-12-19Exact identifier
application applno (NDA): 205889
application number: NDA205889
AirAIRSYOXSA, Inc.0087ce2c-2c34-4a37-83e1-e0cabb87fc7c2025-12-12Exact identifier
application applno (NDA): 205889
application number: NDA205889
OxygenOXYGENT J Nowak Supply Co Inc94540cd6-3795-ac60-e053-2995a90afcbd2025-12-10Exact identifier
application applno (NDA): 205889
application number: NDA205889
OxygenOXYGENTIMS SOUTH TEXAS LLCbd23d80b-7ca3-4cf6-bd90-6b6ec7a1bbf92025-12-09Exact identifier
application applno (NDA): 205889
application number: NDA205889
OxygenOXYGENHELGET, INC.fc4d37c6-d6a1-24ef-e053-6394a90a8b0f2025-12-09Exact identifier
application applno (NDA): 205889
application number: NDA205889
OxygenOXYGENRotech Healthcare Inc28a03918-92a5-1bd0-e063-6394a90ab6722025-12-08Exact identifier
application applno (NDA): 205889
application number: NDA205889
Reconstituted AirRECONSTITUTED AIRHelget Gas Products436c1132-5ac9-b396-e063-6394a90adec42025-12-05Exact identifier
application applno (NDA): 205889
application number: NDA205889
Oxygen/Nitrogen 38/62OXYGEN/NITROGEN 38/62MATHESON TRI-GAS, INC.f5260a57-c389-3e7a-e053-2995a90a30f72025-12-02Exact identifier
application applno (NDA): 205889
application number: NDA205889
Oxygen/Nitrogen 25/75OXYGEN/NITROGEN 25/75MATHESON TRI-GAS, INC.f5260aa2-6da8-25c6-e053-2995a90aca972025-12-02Exact identifier
application applno (NDA): 205889
application number: NDA205889
Oxygen/Nitrogen 9.7/90.3OXYGEN/NITROGEN 9.7/90.3MATHESON TRI-GAS, INC.f52684b1-76fb-2184-e053-2a95a90adca42025-12-02Exact identifier
application applno (NDA): 205889
application number: NDA205889
Oxygen/Nitrogen 10/90OXYGEN/NITROGEN 10/90MATHESON TRI-GAS, INC.f5254763-fef1-1b64-e053-2a95a90aa47e2025-12-02Exact identifier
application applno (NDA): 205889
application number: NDA205889
Oxygen/Helium 25/75OXYGEN/HELIUM 25/75MATHESON TRI-GAS, INC.10bcb7de-ec3a-ee58-e063-6294a90a4a152025-12-02Exact identifier
application applno (NDA): 205889
application number: NDA205889
Oxygen/Nitrogen 15/85OXYGEN/NITROGEN 15/85MATHESON TRI-GAS, INC.f525e843-6efa-25c4-e053-2995a90a9cdd2025-12-02Exact identifier
application applno (NDA): 205889
application number: NDA205889
Oxygen/Nitrogen 26/74OXYGEN/NITROGEN 26/74MATHESON TRI-GAS, INC.f5261ce4-6850-6212-e053-2995a90a42762025-12-02Exact identifier
application applno (NDA): 205889
application number: NDA205889

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