FDA.reportPublic FDA data

Oxygen

Product NDC
49653-003
11-digit product format
496530003
Labeler code
49653
Product ID
49653-003_4393d423-9f92-ef10-e063-6294a90acf11
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxygen
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
Superior Welding Supply Co
Application
NDA205767
Marketing category
NDA
Marketing start
1980-03-21
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
IngredientStrength
OXYGEN990 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
312172Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8eae8423-fe05-46e1-9db9-d18d721bffdeAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49653-003-01Oxygen200 L in 1 CYLINDERGAS2007
49653-003-02Oxygen340 L in 1 CYLINDERGAS3407
49653-003-03Oxygen400 L in 1 PACKAGEGAS4007
49653-003-04Oxygen636 L in 1 CYLINDERGAS6367
49653-003-05Oxygen660 L in 1 CYLINDERGAS6607
49653-003-06Oxygen3240 L in 1 CYLINDERGAS32407
49653-003-07Oxygen7100 L in 1 CYLINDERGAS71007
49653-003-08Oxygen127305 L in 1 CONTAINERGAS1273057

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49653-003OXYGEN GAS [SUPERIOR WELDING SUPPLY CO]6Current NDC, Legacy NDC, 8 package rows20241012_8eae8423-fe05-46e1-9db9-d18d721bffde.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
312172oxygen 99 % Gas for InhalationPSN8eae8423-fe05-46e1-9db9-d18d721bffde7
312172oxygen 99 % Gas for InhalationSCD8eae8423-fe05-46e1-9db9-d18d721bffde7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49653-003-0149653000301200 L in 1 CYLINDER (49653-003-01) 200 l1980-03-210000-00-00NoNoCurrent
49653-003-0249653000302340 L in 1 CYLINDER (49653-003-02) 340 l1980-03-210000-00-00NoNoCurrent
49653-003-0349653000303400 L in 1 PACKAGE (49653-003-03) 400 l1980-03-210000-00-00NoNoCurrent
49653-003-0449653000304636 L in 1 CYLINDER (49653-003-04) 636 l1980-03-210000-00-00NoNoCurrent
49653-003-0549653000305660 L in 1 CYLINDER (49653-003-05) 660 l1980-03-210000-00-00NoNoCurrent
49653-003-06496530003063240 L in 1 CYLINDER (49653-003-06) 3240 l1980-03-210000-00-00NoNoCurrent
49653-003-07496530003077100 L in 1 CYLINDER (49653-003-07) 7100 l1980-03-210000-00-00NoNoCurrent
49653-003-0849653000308127305 L in 1 CONTAINER (49653-003-08) 127305 l1980-03-210000-00-00NoNoCurrent