Home NDC 34057-001-01 Oxygen
Product NDC 34057-001
Requested package NDC 34057-001-01
11-digit product format 340570001
Labeler code 34057
Product ID 34057-001_4475d7e1-086c-87da-e063-6294a90a4a1c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Oxygen
Dosage form GAS
Route RESPIRATORY (INHALATION)
Labeler Oxarc, LLC
Application NDA205849
Marketing category NDA
Marketing start 1977-01-01
Substance OXYGEN
Active strength 990 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 Oxygen
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OXYGEN 990 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 312172 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 34057-001 OXYGEN GAS [OXARC, LLC] 19 Current NDC, Legacy NDC, 33 package rows 20250331_23eabc18-eded-466a-9524-6d0f0e483157.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 4 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 34057-001-01 34057000101 113 L in 1 CYLINDER (34057-001-01) 113 l 1977-01-01 0000-00-00 No No Current