Oxygen

Product NDC
66365-001
11-digit product format
663650001
Labeler code
66365
Product ID
66365-001_40aa5b41-8930-6e56-e063-6294a90a2210
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxygen
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
Medical Comfort Systems Inc
Application
NDA205849
Marketing category
NDA
Marketing start
2001-06-01
Substance
OXYGEN
Active strength
998 mL/L
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage66365-00166365-001-04DDiscontinued by firm2026-08-17
excluded packagepackage66365-00166365-001-06DDiscontinued by firm2026-08-17
excluded packagepackage66365-00166365-001-08DDiscontinued by firm2026-08-17
excluded packagepackage66365-00166365-001-10DDiscontinued 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 · 36 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0566365-001-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0566365-001-06d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0566365-001-04d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0566365-001-08d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2666365-001-04f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2666365-001-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2666365-001-08f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2666365-001-06f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3166365-001-042ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3166365-001-102ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3166365-001-082ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3166365-001-062ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2866365-001-04a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2866365-001-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2866365-001-08a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2866365-001-06a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2166365-001-04cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2166365-001-10cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2166365-001-08cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2166365-001-06cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1066365-001-04cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1066365-001-10cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1066365-001-08cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1066365-001-06cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3166365-001-04302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3166365-001-10302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3166365-001-08302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3166365-001-06302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2066365-001-04ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2066365-001-10ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2066365-001-08ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2066365-001-06ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1066365-001-040efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1066365-001-100efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1066365-001-080efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1066365-001-060efc9e666f02…f202fb6c5f17…

Source provenance: Browse the complete Orange Book source catalog.

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
9f9cb81e-1f28-4091-8a69-17eb6a3bc1c3Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66365-001-01Oxygen70 L in 1 CYLINDERGAS7013
66365-001-02Oxygen248 L in 1 CYLINDERGAS24813
66365-001-03Oxygen415 L in 1 CYLINDERGAS41513
66365-001-04Oxygen682 L in 1 CYLINDERGAS68213
66365-001-05Oxygen1724 L in 1 CYLINDERGAS172413
66365-001-06Oxygen3452 L in 1 CYLINDERGAS345213
66365-001-07Oxygen16750 L in 1 DEWARGAS1675013
66365-001-08Oxygen24950 L in 1 DEWARGAS2495013
66365-001-09Oxygen29069 L in 1 DEWARGAS2906913
66365-001-10Oxygen33500 L in 1 DEWARGAS3350013
66365-001-11Oxygen37619 L in 1 DEWARGAS3761913
66365-001-12Oxygen38300 L in 1 DEWARGAS3830013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66365-001OXYGEN GAS [MEDICAL COMFORT SYSTEMS INC]12Current NDC, Legacy NDC, 12 package rows20241204_9f9cb81e-1f28-4091-8a69-17eb6a3bc1c3.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 · 76 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Oxygen-Helium MixtureOXYGEN-HELIUM MIXTURERoberts Oxygen Company, Inc.2c3b1e14-622f-a6d2-e063-6394a90a0e6d2025-11-17Exact identifier
application applno (NDA): 205849
application number: NDA205849

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
348381oxygen 99.8 % Gas for InhalationPSN9f9cb81e-1f28-4091-8a69-17eb6a3bc1c313
348381oxygen 99.8 % Gas for InhalationSCD9f9cb81e-1f28-4091-8a69-17eb6a3bc1c313

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66365-001-016636500010170 L in 1 CYLINDER (66365-001-01) 70 l2001-06-010000-00-00NoNoCurrent
66365-001-0266365000102248 L in 1 CYLINDER (66365-001-02) 248 l2001-06-010000-00-00NoNoCurrent
66365-001-0366365000103415 L in 1 CYLINDER (66365-001-03) 415 l2001-06-010000-00-00NoNoCurrent
66365-001-0466365000104682 L in 1 CYLINDER (66365-001-04) 682 l2001-06-010000-00-00NoNoCurrent
66365-001-05663650001051724 L in 1 CYLINDER (66365-001-05) 1724 l2001-06-010000-00-00NoNoCurrent
66365-001-06663650001063452 L in 1 CYLINDER (66365-001-06) 3452 l2001-06-010000-00-00NoNoCurrent
66365-001-076636500010716750 L in 1 DEWAR (66365-001-07) 16750 l2001-06-010000-00-00NoNoCurrent
66365-001-086636500010824950 L in 1 DEWAR (66365-001-08) 24950 l2001-06-010000-00-00NoNoCurrent
66365-001-096636500010929069 L in 1 DEWAR (66365-001-09) 29069 l2001-06-010000-00-00NoNoCurrent
66365-001-106636500011033500 L in 1 DEWAR (66365-001-10) 33500 l2001-06-010000-00-00NoNoCurrent
66365-001-116636500011137619 L in 1 DEWAR (66365-001-11) 37619 l2001-06-010000-00-00NoNoCurrent
66365-001-126636500011238300 L in 1 DEWAR (66365-001-12) 38300 l2001-06-010000-00-00NoNoCurrent