FDA.reportPublic FDA data

Helium Oxygen Mix

Product NDC
48883-007
11-digit product format
488830007
Labeler code
48883
Product ID
48883-007_7f1be800-2f65-44ac-b6fa-df6904a1b0ec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Helium Oxygen Mix
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
Encompass Medical & Specialty Gases Ltd
Marketing category
UNAPPROVED MEDICAL GAS
Marketing start
2009-04-15
Marketing end
0000-00-00
Substance
HELIUM; OXYGEN
Active strength
500 mL/L; mL/L
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
48883-007-012019-11-13C16284748780-197449f38-d3af-f6ea-e053-dbdaa90aa703Helium Oxygen Mix Label
48883-007-022019-11-13C16284748780-197449f38-d3af-f6ea-e053-dbdaa90aa703Helium Oxygen Mix Label
48883-007-032019-11-13C16284748780-197449f38-d3af-f6ea-e053-dbdaa90aa703Helium Oxygen Mix Label
48883-007-042019-11-13C16284748780-197449f38-d3af-f6ea-e053-dbdaa90aa703Helium Oxygen Mix Label
48883-007-052019-11-13C16284748780-197449f38-d3af-f6ea-e053-dbdaa90aa703Helium Oxygen Mix Label
48883-007-062019-11-13C16284748780-197449f38-d3af-f6ea-e053-dbdaa90aa703Helium Oxygen Mix Label
48883-007-072019-11-13C16284748780-197449f38-d3af-f6ea-e053-dbdaa90aa703Helium Oxygen Mix Label
48883-007-082019-11-13C16284748780-197449f38-d3af-f6ea-e053-dbdaa90aa703Helium Oxygen Mix Label
48883-007-092019-11-13C16284748780-197449f38-d3af-f6ea-e053-dbdaa90aa703Helium Oxygen Mix Label
48883-007-102019-11-13C16284748780-197449f38-d3af-f6ea-e053-dbdaa90aa703Helium Oxygen Mix Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48883-007-01Helium Oxygen Mix617 L in 1 CYLINDERGAS6173
48883-007-02Helium Oxygen Mix623 L in 1 CYLINDERGAS6233
48883-007-03Helium Oxygen Mix629 L in 1 CYLINDERGAS6293
48883-007-04Helium Oxygen Mix640 L in 1 CYLINDERGAS6403
48883-007-05Helium Oxygen Mix654 L in 1 CYLINDERGAS6543
48883-007-06Helium Oxygen Mix5689 L in 1 CYLINDERGAS56893
48883-007-07Helium Oxygen Mix5743 L in 1 CYLINDERGAS57433
48883-007-08Helium Oxygen Mix5796 L in 1 CYLINDERGAS57963
48883-007-09Helium Oxygen Mix5904 L in 1 CYLINDERGAS59043
48883-007-10Helium Oxygen Mix6009 L in 1 CYLINDERGAS60093

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HeliumACTIVE INGREDIENT206GF3GB41HELIUM OXYGEN MIX GAS [ENCOMPASS MEDICAL & SPECIALTY GASES LTD]3
OxygenACTIVE INGREDIENTS88TT14065HELIUM OXYGEN MIX GAS [ENCOMPASS MEDICAL & SPECIALTY GASES LTD]3
HeliumACTIVE MOIETY206GF3GB41HELIUM OXYGEN MIX GAS [ENCOMPASS MEDICAL & SPECIALTY GASES LTD]3
OxygenACTIVE MOIETYS88TT14065HELIUM OXYGEN MIX GAS [ENCOMPASS MEDICAL & SPECIALTY GASES LTD]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48883-007HELIUM OXYGEN MIX GAS [ENCOMPASS MEDICAL & SPECIALTY GASES LTD]3Legacy NDC, 10 package rows20111230_298bce73-9e59-40e1-ad71-97b2db89b696.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
48883-007-0148883000701617 L in 1 CYLINDER617 lHistorical
48883-007-0248883000702623 L in 1 CYLINDER623 lHistorical
48883-007-0348883000703629 L in 1 CYLINDER629 lHistorical
48883-007-0448883000704640 L in 1 CYLINDER640 lHistorical
48883-007-0548883000705654 L in 1 CYLINDER654 lHistorical
48883-007-06488830007065689 L in 1 CYLINDER5689 lHistorical
48883-007-07488830007075743 L in 1 CYLINDER5743 lHistorical
48883-007-08488830007085796 L in 1 CYLINDER5796 lHistorical
48883-007-09488830007095904 L in 1 CYLINDER5904 lHistorical
48883-007-10488830007106009 L in 1 CYLINDER6009 lHistorical