FDA.reportPublic FDA data

Oxygen

Product NDC
81681-001
11-digit product format
816810001
Labeler code
81681
Product ID
81681-001_4586f85c-0193-5cca-e063-6294a90ae078
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxygen
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
WEST PENN LACO, INC.
Application
NDA205767
Marketing category
NDA
Marketing start
2021-03-09
Substance
OXYGEN
Active strength
998 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
IngredientStrength
OXYGEN998 mL/L

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
S88TT14065Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
348381Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
bd2023e7-da7d-7777-e053-2995a90aa64fAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81681-001-01Oxygen424.75 L in 1 CYLINDERGAS424.759
81681-001-02Oxygen622.97 L in 1 CYLINDERGAS622.979
81681-001-03Oxygen3539.61 L in 1 CYLINDERGAS3539.619
81681-001-04Oxygen7101.53 L in 1 CYLINDERGAS7101.539
81681-001-05Oxygen3539.61 L in 1 CYLINDERGAS3539.619
81681-001-06Oxygen254.85 L in 1 CYLINDERGAS254.859

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81681-001OXYGEN GAS [WEST PENN LACO, INC.]8Current NDC, Legacy NDC, 6 package rows20241204_bd2023e7-da7d-7777-e053-2995a90aa64f.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 5 of 5 · 82 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OXYGENOXYGENNoble Gas Solutions, Inc.13ce9fe8-ca43-4564-87b2-f8e97570dcfd2024-10-06Exact identifier
application applno (NDA): 205767
application number: NDA205767
OxygenOXYGENADF Welding & Medical, Inc.01efe36d-5281-4ede-bc30-9a1727a86a832024-10-02Exact identifier
application applno (NDA): 205767
application number: NDA205767

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
348381oxygen 99.8 % Gas for InhalationPSNbd2023e7-da7d-7777-e053-2995a90aa64f9
348381oxygen 99.8 % Gas for InhalationSCDbd2023e7-da7d-7777-e053-2995a90aa64f9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81681-001-0181681000101424.75 L in 1 CYLINDER (81681-001-01) 424.75 l2021-03-090000-00-00NoNoCurrent
81681-001-0281681000102622.97 L in 1 CYLINDER (81681-001-02) 622.97 l2021-03-090000-00-00NoNoCurrent
81681-001-03816810001033539.61 L in 1 CYLINDER (81681-001-03) 3539.61 l2021-03-090000-00-00NoNoCurrent
81681-001-04816810001047101.53 L in 1 CYLINDER (81681-001-04) 7101.53 l2021-03-090000-00-00NoNoCurrent
81681-001-05816810001053539.61 L in 1 CYLINDER (81681-001-05) 3539.61 l2021-03-090000-00-00NoNoCurrent
81681-001-0681681000106254.85 L in 1 CYLINDER (81681-001-06) 254.85 l2021-03-09NoNoCurrent