FDA.reportPublic FDA data

Oxygen

Product NDC
63961-100
Requested package NDC
63961-100-16
11-digit product format
639610100
Labeler code
63961
Product ID
63961-100_eb3d2f64-b389-400a-e053-2a95a90a0b51
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxygen
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
Middlesex Gases and Technologies, Inc.
Application
NDA205849
Marketing category
NDA
Marketing start
1997-07-28
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63961-10063961-100-16IInactivated by FDA2026-10-05

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.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63961-100-11Oxygen424 L in 1 CYLINDERGAS42412
63961-100-12Oxygen707 L in 1 CYLINDERGAS70712
63961-100-13Oxygen3539 L in 1 CYLINDERGAS353912
63961-100-14Oxygen7107 L in 1 CYLINDERGAS710712
63961-100-15Oxygen167918 L in 1 CYLINDERGAS16791812
63961-100-16Oxygen144302 L in 1 CYLINDERGAS14430212
63961-100-17Oxygen1282753 L in 1 CYLINDERGAS128275312
63961-100-18Oxygen176810 L in 1 CYLINDERGAS17681012
63961-100-19Oxygen9542 L in 1 CYLINDERGAS954212

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OxygenACTIVE INGREDIENTS88TT14065OXYGEN GAS [MIDDLESEX GASES AND TECHNOLOGIES, INC.]1
OxygenACTIVE MOIETYS88TT14065OXYGEN GAS [MIDDLESEX GASES AND TECHNOLOGIES, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63961-100OXYGEN GAS [MIDDLESEX GASES AND TECHNOLOGIES, INC.]12Legacy NDC, 9 package rows20241109_a0c7053b-5692-402e-b5d0-6de2b189deff.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OXYGENOXYGENChildrens Hospital of Philadelphia36b3f07a-d7f9-4d52-b40a-73d65e4f83ba2026-08-26Exact identifier
application applno (NDA): 205849
application number: NDA205849
OxygenOXYGENEmpresas De Soldaduras6f57cec9-9132-4ba4-a033-538c3a39ff9c2026-07-27Exact identifier
application applno (NDA): 205849
application number: NDA205849
OxygenOXYGENAdvantage Respiratory Services972755ee-f07f-485c-ba34-8e601f4685122026-06-18Exact identifier
application applno (NDA): 205849
application number: NDA205849
OxygenOXYGENNexAir, LLCaba44023-4919-4711-992c-aa59dfe366a92026-05-21Exact identifier
application applno (NDA): 205849
application number: NDA205849
OxygenOXYGENLinde Gas & Equipment Inc.a5bcde43-c0e8-4db8-bd4f-6f3af00b9b172026-04-20Exact identifier
application applno (NDA): 205849
application number: NDA205849
OxygenOXYGENAlbright Welding Supply Co., Inc.80c05bc5-4918-4998-b5eb-4ca8b59bf7162026-01-08Exact identifier
application applno (NDA): 205849
application number: NDA205849
NitrogenNITROGENLinde Puerto Rico B.V.4e5df6ce-06ef-498f-b064-b2b6e15219512025-12-31Exact identifier
application applno (NDA): 205849
application number: NDA205849
OxygenOXYGENLinde Inc.58ca942f-16ba-49fe-a1aa-d62dddeaca6b2025-12-30Exact identifier
application applno (NDA): 205849
application number: NDA205849
Carbon Dioxide Oxygen MixCARBON DIOXIDE OXYGEN MIXLinde Gas & Equipment Inc.b5f6d869-6875-4c82-9311-98a148790c0b2025-12-19Exact identifier
application applno (NDA): 205849
application number: NDA205849
AirAIRGeneral Air Service & Supply Co60df0f08-6622-6cb5-e053-2a91aa0a77602025-11-26Exact identifier
application applno (NDA): 205849
application number: NDA205849
Carbon Dioxide Oxygen MixtureCARBON DIOXIDE OXYGEN MIXTUREGeneral Air Service & Supply Co620d348d-75e6-3d1a-e053-2991aa0a855f2025-11-26Exact identifier
application applno (NDA): 205849
application number: NDA205849
Oxygen Nitrogen MixtureOXYGEN NITROGEN MIXTUREGeneral Air Service & Supply Co.c7f7500c-b521-4d93-a567-898ca4f778f42025-11-26Exact identifier
application applno (NDA): 205849
application number: NDA205849
Helium/Oxygen Mixture 80/20HELIUM/OXYGEN MIXTURE 80/20General Air Service & Supply Co.60df34a1-e3fa-6959-e053-2a91aa0a47602025-11-26Exact identifier
application applno (NDA): 205849
application number: NDA205849
Helium/Oxygen Mixture 70/30HELIUM/OXYGEN MIXTURE 70/30General Air Service & Supply Co620d5fe1-f7f1-8de7-e053-2a91aa0a86642025-11-26Exact identifier
application applno (NDA): 205849
application number: NDA205849
OxygenOXYGENGeneral Air Service & Supply Co60399781-bcf4-4675-afb9-6d8b2670efa02025-11-26Exact identifier
application applno (NDA): 205849
application number: NDA205849
OxygenOXYGENOxarc, LLC23eabc18-eded-466a-9524-6d0f0e4831572025-11-25Exact identifier
application applno (NDA): 205849
application number: NDA205849
OxygenOXYGENGeneral Cryogenic Technologies LLCc071ca0b-a330-4579-a1b8-d4b4c5824a092025-11-21Exact identifier
application applno (NDA): 205849
application number: NDA205849
OxygenOXYGENT.W. Smith Corp.35835f7d-2f1e-0e11-e063-6294a90ad5262025-11-19Exact identifier
application applno (NDA): 205849
application number: NDA205849
Oxygen-Helium MixtureOXYGEN-HELIUM MIXTURERoberts Oxygen Company, Inc.2c3b2f64-cf21-d203-e063-6394a90a52de2025-11-17Exact identifier
application applno (NDA): 205849
application number: NDA205849
Oxygen-Nitrogen MixtureOXYGEN-NITROGEN MIXTURERoberts Oxygen Company, Inc.2bed8d10-0a93-3c8a-e063-6294a90a91002025-11-17Exact identifier
application applno (NDA): 205849
application number: NDA205849

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312172oxygen 99 % Gas for InhalationPSNa0c7053b-5692-402e-b5d0-6de2b189deff12
312172oxygen 99 % Gas for InhalationSCDa0c7053b-5692-402e-b5d0-6de2b189deff12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63961-100-1663961010016144302 L in 1 CYLINDER (63961-100-16) 144302 l1997-07-280000-00-00NoNoCurrent