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

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
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 2 of 3 · 49 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oxygen/Nitrogen 12/88OXYGEN/NITROGEN 12/88MATHESON TRI-GAS, INC.f525d24f-5008-93aa-e053-2a95a90acbcb2025-12-02Exact identifier
application applno (NDA): 205889
application number: NDA205889
Oxygen/Nitrogen 30/70OXYGEN/NITROGEN 30/70MATHESON TRI-GAS, INC.f5262a2b-6bd4-4615-e053-2995a90aaf582025-12-02Exact identifier
application applno (NDA): 205889
application number: NDA205889
Oxygen/Nitrogen 52/48OXYGEN/NITROGEN 52/48MATHESON TRI-GAS, INC.f5266e8f-60fb-cd73-e053-2995a90a021d2025-12-02Exact identifier
application applno (NDA): 205889
application number: NDA205889
Oxygen/Nitrogen 50/50OXYGEN/NITROGEN 50/50MATHESON TRI-GAS, INC.f5266223-b40d-6c48-e053-2995a90a39122025-12-02Exact identifier
application applno (NDA): 205889
application number: NDA205889
Oxygen/Nitrogen 40/60OXYGEN/NITROGEN 40/60MATHESON TRI-GAS, INC.f52647f0-aba5-501d-e053-2995a90a94642025-12-02Exact identifier
application applno (NDA): 205889
application number: NDA205889
Oxygen/Helium 40/60OXYGEN/HELIUM 40/60MATHESON TRI-GAS, INC.10bcc7cd-ce72-5e9d-e063-6394a90a17e22025-12-02Exact identifier
application applno (NDA): 205889
application number: NDA205889
Oxygen/Nitrogen 5/95OXYGEN/NITROGEN 5/95MATHESON TRI-GAS, INC.f526545f-712a-6c4a-e053-2995a90abab02025-12-02Exact identifier
application applno (NDA): 205889
application number: NDA205889
Oxygen/Nitrogen 75/25OXYGEN/NITROGEN 75/25MATHESON TRI-GAS, INC.f526707a-f4cd-37af-e053-2995a90a85242025-12-02Exact identifier
application applno (NDA): 205889
application number: NDA205889
Carbon Dioxide/Oxygen 5/95CARBON DIOXIDE/OXYGEN 5/95MATHESON TRI-GAS, INC.10bcb4be-21f8-0683-e063-6294a90a50362025-12-02Exact identifier
application applno (NDA): 205889
application number: NDA205889
Oxygen/Helium 20/80OXYGEN/HELIUM 20/80MATHESON TRI-GAS, INC.10bcb79f-9346-5b4c-e063-6394a90a0c262025-12-02Exact identifier
application applno (NDA): 205889
application number: NDA205889
Carbon Dioxide OxygenCARBON DIOXIDE OXYGENMATHESON TRI-GAS, INC.10bca54e-777c-03f5-e063-6294a90aed2c2025-12-02Exact identifier
application applno (NDA): 205889
application number: NDA205889
Oxygen/Helium 50/50OXYGEN/HELIUM 50/50MATHESON TRI-GAS, INC.10bcc7cd-ce75-5e9d-e063-6394a90a17e22025-12-02Exact identifier
application applno (NDA): 205889
application number: NDA205889
Oxygen/Nitrogen 21/79OXYGEN/NITROGEN 21/79MATHESON TRI-GAS, INC.f5255f85-970d-43c7-e053-2995a90ac4362025-12-02Exact identifier
application applno (NDA): 205889
application number: NDA205889
Oxygen/Helium 30/70OXYGEN/HELIUM 30/70MATHESON TRI-GAS, INC.10bcca0f-1f2b-1163-e063-6294a90af1862025-12-02Exact identifier
application applno (NDA): 205889
application number: NDA205889
OXYGENOXYGENVolunteer Welding Supply Inc2e9baf05-c0d3-4361-82c3-e18a5bca8cd12025-11-26Exact identifier
application applno (NDA): 205889
application number: NDA205889
OxygenOXYGENIsland Supply Welding Co Inc9a84e50c-504a-4e7d-8595-ebce7d78d1272025-11-21Exact identifier
application applno (NDA): 205889
application number: NDA205889
OxygenOXYGENMAVERICK OXYGEN & RESPIRATORY EQUIPMENT, LLC82316046-e3e0-7b8d-e053-2a91aa0aa69b2025-11-18Exact identifier
application applno (NDA): 205889
application number: NDA205889
AirAIRGeneral Distributing Company60cf6286-12d5-24a1-e053-2991aa0a9d742025-11-14Exact identifier
application applno (NDA): 205889
application number: NDA205889
OxygenOXYGENGeneral Distributing Co.ffa52347-b223-4ff8-acaa-1462f2dfb5282025-11-14Exact identifier
application applno (NDA): 205889
application number: NDA205889
OxygenOXYGENModern Supply Company, Inc.4a1cddbc-27f1-4a7c-b2de-5158bddf3efd2025-10-30Exact 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
84078-004-02840780004026029 L in 1 CYLINDER (84078-004-02) 6029 l2026-01-26NoNoCurrent