Home NDC 84120-005-05 RECONSTITUTED AIR
Product NDC 84120-005
Requested package NDC 84120-005-05
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 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 2026-12-31 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# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84120-005 RECONSTITUTED AIR GAS [WSM SUPPLIER LLC.] 2 Current NDC, 14 package rows 20241204_17e3afd9-e900-1d44-e063-6294a90a0472.zip
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 84120-005-05 84120000505 3030 L in 1 CYLINDER (84120-005-05) 3030 l 2024-05-07 No No Current