Helium

Helium

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

Company

DUNS: 004532065

Effective Date

October 17, 2023

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

Aero All Gas Company

DUNS Number

004532065

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

NDC Product Code

10014-004

Application Number

NDA206826

Marketing Category

NDA (C73594)

Route of Administration

RESPIRATORY (INHALATION)

Effective Date

October 17, 2023

Ingredients

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