Helium

Helium

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

Company

Encompass Medical & Specialty Gases, Ltd.

DUNS: 963344143

Effective Date

December 20, 2010

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Helium(990 mL in 1 L)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Labeler

Encompass Medical & Specialty Gases, Ltd.

DUNS Number

963718361

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

NDC Product Code

48883-006

Route of Administration

RESPIRATORY (INHALATION)

Effective Date

December 6, 2010

Ingredients

Code: 206GF3GB41Class: ACTIBQuantity: 990 mL in 1 L