Home NDC 82457-004-02 Oxygen
Product NDC 82457-004
Requested package NDC 82457-004-02
11-digit product format 824570004
Labeler code 82457
Product ID 82457-004_4252daaf-7156-9025-e063-6394a90ab479
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Oxygen
Dosage form GAS
Route RESPIRATORY (INHALATION)
Labeler Toll Company
Application NDA205849
Marketing category NDA
Marketing start 2021-12-17
Substance OXYGEN
Active strength 995 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 995 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 312173 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 82457-004 OXYGEN GAS [TOLL COMPANY] 2 Current NDC, 7 package rows 20241122_07dccf95-bc1f-69a4-e063-6394a90a922b.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 Sample Exclude flag Status 82457-004-02 82457000402 8495 L in 1 CYLINDER (82457-004-02) 8495 l 2021-12-17 No No Current