Home NDC 12213-801-12 Helium/Oxygen Mix
Product NDC 12213-801
Requested package NDC 12213-801-12
11-digit product format 122130801
Labeler code 12213
Product ID 12213-801_4279490a-a12b-05d4-e063-6394a90afa67
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Helium/Oxygen Mix
Dosage form GAS
Route RESPIRATORY (INHALATION)
Labeler NEXAIR, LLC
Application NDA205849
Marketing category NDA
Marketing start 1996-06-01
Substance OXYGEN
Active strength 200 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 Helium/Oxygen Mix
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OXYGEN 200 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 413101 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 12213-801 HELIUM/OXYGEN MIX GAS [NEXAIR, LLC] 9 Current NDC, Legacy NDC, 9 package rows 20241114_60dd4f4b-7132-385e-e053-2a91aa0ad5d6.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 4 · 77 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 12213-801-12 12213080112 5663 L in 1 CYLINDER (12213-801-12) 5663 l 1996-06-01 0000-00-00 No No Current