Home NDC 48546-0003 NITROGEN
Product NDC 48546-0003
11-digit product format 485460003
Labeler code 48546
Product ID 48546-0003_ef4df6dd-530d-402f-bd73-42d5b79244d3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name NITROGEN
Dosage form GAS
Route RESPIRATORY (INHALATION)
Labeler Indiana Oxygen Company Inc
Application NDA205766
Marketing category NDA
Marketing start 1975-01-01
Substance NITROGEN
Active strength 99 L/100L
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 NITROGEN
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NITROGEN 99 L/100L
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 311998 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 48546-0003 NITROGEN GAS [INDIANA OXYGEN COMPANY INC] 13 Current NDC, Legacy NDC, 9 package rows 20241025_68349b39-b874-4df5-813a-8633c12787ce.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 3 of 3 · 41 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 48546-0003-1 48546000301 6400 L in 1 CYLINDER (48546-0003-1) 6400 l 1975-01-01 0000-00-00 No No Current 48546-0003-2 48546000302 4220 L in 1 DEWAR (48546-0003-2) 4220 l 1975-01-01 0000-00-00 No No Current 48546-0003-3 48546000303 1140 L in 1 CYLINDER (48546-0003-3) 1140 l 1975-01-01 0000-00-00 No No Current 48546-0003-4 48546000304 2280 L in 1 CYLINDER (48546-0003-4) 2280 l 1975-01-01 0000-00-00 No No Current 48546-0003-5 48546000305 3190 L in 1 CYLINDER (48546-0003-5) 3190 l 1975-01-01 0000-00-00 No No Current 48546-0003-6 48546000306 4890 L in 1 CYLINDER (48546-0003-6) 4890 l 1975-01-01 0000-00-00 No No Current 48546-0003-7 48546000307 6340 L in 1 CYLINDER (48546-0003-7) 6340 l 1975-01-01 0000-00-00 No No Current 48546-0003-8 48546000308 8420 L in 1 CYLINDER (48546-0003-8) 8420 l 1975-01-01 0000-00-00 No No Current 48546-0003-9 48546000309 119935 L in 1 DEWAR (48546-0003-9) 119935 l 1975-01-01 0000-00-00 No No Current