FDA.reportPublic FDA data

OXYGEN

Product NDC
10218-001
11-digit product format
102180001
Labeler code
10218
Product ID
10218-001_4bae463f-cd7b-3ffd-e063-6294a90adb7a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OXYGEN
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
CEE-KAY SUPPLY, INC.
Application
NDA205767
Marketing category
NDA
Marketing start
1997-04-05
Substance
OXYGEN
Active strength
995 mL/L
NDC exclude flag
No
Listing certified through
2027-12-31
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
2027-12-31

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
7a4aa7ab-08a4-4e93-90d7-5329b0e1a61bAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10218-001-01OXYGEN8500 L in 1 CYLINDERGAS850017
10218-001-02OXYGEN6000 L in 1 CYLINDERGAS600017
10218-001-03OXYGEN3000 L in 1 CYLINDERGAS300017
10218-001-04OXYGEN2000 L in 1 CYLINDERGAS200017
10218-001-05OXYGEN1000 L in 1 CYLINDERGAS100017
10218-001-06OXYGEN650 L in 1 CYLINDERGAS65017
10218-001-07OXYGEN400 L in 1 CYLINDERGAS40017
10218-001-08OXYGEN177 L in 1 DEWARGAS17717
10218-001-09OXYGEN146 L in 1 DEWARGAS14617
10218-001-10OXYGEN196 L in 1 DEWARGAS19617

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXYGENACTIVE INGREDIENTS88TT14065OXYGEN GAS [CEE-KAY SUPPLY, INC.]5
OXYGENACTIVE MOIETYS88TT14065OXYGEN GAS [CEE-KAY SUPPLY, INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10218-001OXYGEN GAS [CEE-KAY SUPPLY, INC.]15Current NDC, Legacy NDC, 10 package rows20241023_7a4aa7ab-08a4-4e93-90d7-5329b0e1a61b.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 InhalationPSN7a4aa7ab-08a4-4e93-90d7-5329b0e1a61b17
312173oxygen 99.5 % Gas for InhalationSCD7a4aa7ab-08a4-4e93-90d7-5329b0e1a61b17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10218-001-01102180001018500 L in 1 CYLINDER (10218-001-01) 8500 l1997-04-050000-00-00NoNoCurrent
10218-001-02102180001026000 L in 1 CYLINDER (10218-001-02) 6000 l1997-04-050000-00-00NoNoCurrent
10218-001-03102180001033000 L in 1 CYLINDER (10218-001-03) 3000 l1997-04-050000-00-00NoNoCurrent
10218-001-04102180001042000 L in 1 CYLINDER (10218-001-04) 2000 l1997-04-050000-00-00NoNoCurrent
10218-001-05102180001051000 L in 1 CYLINDER (10218-001-05) 1000 l1997-04-050000-00-00NoNoCurrent
10218-001-0610218000106650 L in 1 CYLINDER (10218-001-06) 650 l1997-04-050000-00-00NoNoCurrent
10218-001-0710218000107400 L in 1 CYLINDER (10218-001-07) 400 l1997-04-050000-00-00NoNoCurrent
10218-001-0810218000108177 L in 1 DEWAR (10218-001-08) 177 l1997-04-050000-00-00NoNoCurrent
10218-001-0910218000109146 L in 1 DEWAR (10218-001-09) 146 l1997-04-050000-00-00NoNoCurrent
10218-001-1010218000110196 L in 1 DEWAR (10218-001-10) 196 l1997-04-05NoNoCurrent