FDA.reportPublic FDA data

Oxygen

Product NDC
83746-002
11-digit product format
837460002
Labeler code
83746
Product ID
83746-002_4573753d-1179-a6f2-e063-6394a90ae2f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxygen
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
Gas and Supply Carolinas, LLC
Application
NDA205767
Marketing category
NDA
Marketing start
2023-10-16
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
IngredientStrength
OXYGEN995 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
312173Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
05a73ef4-f9ba-f4fc-e063-6294a90a8321Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83746-002-01Oxygen198 L in 1 CYLINDERGAS1983
83746-002-02Oxygen420 L in 1 CYLINDERGAS4203
83746-002-03Oxygen707 L in 1 CYLINDERGAS7073
83746-002-04Oxygen3160 L in 1 CYLINDERGAS31603
83746-002-05Oxygen3470 L in 1 CYLINDERGAS34703
83746-002-06Oxygen6456 L in 1 CYLINDERGAS64563
83746-002-07Oxygen7107 L in 1 CYLINDERGAS71073
83746-002-08Oxygen7249 L in 1 CYLINDERGAS72493
83746-002-09Oxygen7957 L in 1 CYLINDERGAS79573
83746-002-10Oxygen8510 L in 1 CYLINDERGAS85103
83746-002-11Oxygen9340 L in 1 CYLINDERGAS93403
83746-002-12Oxygen180 L in 1 DEWARGAS1803
83746-002-13Oxygen200 L in 1 DEWARGAS2003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83746-002OXYGEN GAS [GAS AND SUPPLY CAROLINAS, LLC]2Current NDC, 13 package rows20241030_05a73ef4-f9ba-f4fc-e063-6294a90a8321.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
312173oxygen 99.5 % Gas for InhalationPSN05a73ef4-f9ba-f4fc-e063-6294a90a83213
312173oxygen 99.5 % Gas for InhalationSCD05a73ef4-f9ba-f4fc-e063-6294a90a83213

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83746-002-0183746000201198 L in 1 CYLINDER (83746-002-01) 198 l2023-10-16NoNoCurrent
83746-002-0283746000202420 L in 1 CYLINDER (83746-002-02) 420 l2023-10-16NoNoCurrent
83746-002-0383746000203707 L in 1 CYLINDER (83746-002-03) 707 l2023-10-16NoNoCurrent
83746-002-04837460002043160 L in 1 CYLINDER (83746-002-04) 3160 l2023-10-16NoNoCurrent
83746-002-05837460002053470 L in 1 CYLINDER (83746-002-05) 3470 l2023-10-16NoNoCurrent
83746-002-06837460002066456 L in 1 CYLINDER (83746-002-06) 6456 l2023-10-16NoNoCurrent
83746-002-07837460002077107 L in 1 CYLINDER (83746-002-07) 7107 l2023-10-16NoNoCurrent
83746-002-08837460002087249 L in 1 CYLINDER (83746-002-08) 7249 l2023-10-16NoNoCurrent
83746-002-09837460002097957 L in 1 CYLINDER (83746-002-09) 7957 l2023-10-16NoNoCurrent
83746-002-10837460002108510 L in 1 CYLINDER (83746-002-10) 8510 l2023-10-16NoNoCurrent
83746-002-11837460002119340 L in 1 CYLINDER (83746-002-11) 9340 l2023-10-16NoNoCurrent
83746-002-1283746000212180 L in 1 DEWAR (83746-002-12) 180 l2023-10-16NoNoCurrent
83746-002-1383746000213200 L in 1 DEWAR (83746-002-13) 200 l2023-10-16NoNoCurrent