Home NDC 84078-001-04 Nitrogen
Product NDC 84078-001
Requested package NDC 84078-001-04
11-digit product format 840780001
Labeler code 84078
Product ID 84078-001_50871b9d-735b-0673-e063-6294a90a560d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Nitrogen
Dosage form GAS
Route RESPIRATORY (INHALATION)
Labeler WELDERS SUPPLY COMPANY OF LOUISVILLE, INC.
Application NDA205891
Marketing category NDA
Marketing start 2024-01-29
Substance NITROGEN
Active strength 992 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 Nitrogen
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NITROGEN 992 mL/L
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination N762921K75 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 348624 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 84078-001 NITROGEN GAS [WELDERS SUPPLY COMPANY OF LOUISVILLE, INC.] 2 Current NDC, 12 package rows 20241204_1017e562-498d-9554-e063-6394a90ab566.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 1 · 12 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 84078-001-04 84078000104 651 L in 1 CYLINDER (84078-001-04) 651 l 2024-01-29 No No Current