Home NDC 84078-004 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 Ingredient Strength OXYGEN 210 mL/L
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination S88TT14065 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 347123 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 84078-004-01 RECONSTITUTED AIR 663 L in 1 CYLINDER GAS 663 1 84078-004-02 RECONSTITUTED AIR 6029 L in 1 CYLINDER GAS 6029 1
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 2 · 25 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 84078-004-01 84078000401 663 L in 1 CYLINDER (84078-004-01) 663 l 2026-01-26 No No Current 84078-004-02 84078000402 6029 L in 1 CYLINDER (84078-004-02) 6029 l 2026-01-26 No No Current