FDA.reportPublic FDA data

Oxygen

Product NDC
68540-001
11-digit product format
685400001
Labeler code
68540
Product ID
68540-001_eb3d8a19-7bdc-dd8c-e053-2995a90ae3b3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxygen
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
Price Rite Medical Equipment, Inc.
Application
NDA205820
Marketing category
NDA
Marketing start
2002-01-01
Marketing end
0000-00-00
Substance
OXYGEN
Active strength
990 mL/L
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68540-001DDiscontinued by firm2026-08-17
excluded packagepackage68540-00168540-001-01DDiscontinued by firm2026-08-17
excluded packagepackage68540-00168540-001-02DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct68540-001DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68540-00168540-001-02DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68540-00168540-001-01DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

Source provenance: Browse the complete Orange Book source catalog.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OxygenACTIVE INGREDIENTS88TT14065OXYGEN GAS [PRICE RITE MEDICAL EQUIPMENT, INC.]2
OxygenACTIVE MOIETYS88TT14065OXYGEN GAS [PRICE RITE MEDICAL EQUIPMENT, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68540-001OXYGEN GAS [PRICE RITE MEDICAL EQUIPMENT, INC.]11Legacy NDC20241114_f8634c09-dad0-4399-a965-3c41c1c24e44.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OXYGENOXYGENNorco, Inc.f47d15a8-f534-4ef2-bc3d-26a05d5412202025-12-12Exact identifier
application applno (NDA): 205820
application number: NDA205820
MEDICAL AIROXYGENNorco, Inc.b54cea1e-2c36-455b-b1a2-a5472d8737262025-08-31Exact identifier
application applno (NDA): 205820
application number: NDA205820
OXYGENOXYGENLogan Healthd87e6283-9639-42ae-acba-9d000086b4662025-02-19Exact identifier
application applno (NDA): 205820
application number: NDA205820

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68540-001-016854000010146 L in 1 CAN (68540-001-01) 46 l2002-01-010000-00-00NoNoCurrent
68540-001-026854000010223 L in 1 CYLINDER (68540-001-02) 23 l2002-01-010000-00-00NoNoCurrent