MedPath

HELIOX

Approved
Approval ID

f0fd422f-ddbc-4259-90da-8822028210c7

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 27, 2011

Manufacturers
FDA

Acetylene Oxygen Company

DUNS: 008110181

Products 3

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

HELIOX

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code10006-011
Product Classification
G
Generic Name
HELIOX
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateApril 27, 2011
FDA Product Classification

INGREDIENTS (2)

HELIUMInactive
Quantity: 70 L in 100 L
Code: 206GF3GB41
Classification: IACT
OXYGENActive
Quantity: 30 L in 100 L
Code: S88TT14065
Classification: ACTIB

HELIOX

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code10006-009
Product Classification
G
Generic Name
HELIOX
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateApril 27, 2011
FDA Product Classification

INGREDIENTS (2)

OXYGENActive
Quantity: 20 L in 100 L
Code: S88TT14065
Classification: ACTIB
HELIUMInactive
Quantity: 80 L in 100 L
Code: 206GF3GB41
Classification: IACT

HELIOX

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code10006-010
Product Classification
G
Generic Name
HELIOX
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateApril 27, 2011
FDA Product Classification

INGREDIENTS (2)

OXYGENActive
Quantity: 25 L in 100 L
Code: S88TT14065
Classification: ACTIB
HELIUMInactive
Quantity: 75 L in 100 L
Code: 206GF3GB41
Classification: IACT

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HELIOX - FDA Drug Approval Details