FDA.reportPublic FDA data

Oxygen

Product NDC
84228-001
11-digit product format
842280001
Labeler code
84228
Product ID
84228-001_42661a41-43e1-3b61-e063-6294a90a3b25
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxygen
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
Specialty Medical Products, Inc.
Marketing category
UNAPPROVED MEDICAL GAS
Marketing start
2024-04-02
Substance
OXYGEN
Active strength
99 L/100L
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Oxygen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYGEN99 L/100L

Harmonized Identifiers#

Field, Values table
FieldValues
UniiS88TT14065
Rxcui312172

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84228-001-01Oxygen164 L in 1 CYLINDERGAS1644
84228-001-02Oxygen425 L in 1 CYLINDERGAS4254
84228-001-03Oxygen680 L in 1 CYLINDERGAS6804

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84228-001OXYGEN GAS [SPECIALTY MEDICAL PRODUCTS, INC.]3Current NDC, 3 package rows20250330_150abd22-d570-86f6-e063-6294a90ae02e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312172oxygen 99 % Gas for InhalationPSN150abd22-d570-86f6-e063-6294a90ae02e4
312172oxygen 99 % Gas for InhalationSCD150abd22-d570-86f6-e063-6294a90ae02e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84228-001-0184228000101164 L in 1 CYLINDER164 lHistorical
84228-001-0284228000102425 L in 1 CYLINDER (84228-001-02) 425 l2024-04-02NoNoHistorical
84228-001-0384228000103680 L in 1 CYLINDER (84228-001-03) 680 l2024-04-02NoNoHistorical