MedPath

Nitrogen

Nitrogen-003

Approved
Approval ID

273511c2-2b84-4373-a0e5-3961eb19af8c

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 16, 2023

Manufacturers
FDA

Roberts Oxygen Company, Inc

DUNS: 042646877

Products 1

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

Nitrogen

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code46123-003
Application NumberNDA205850
Product Classification
M
Marketing Category
C73594
G
Generic Name
Nitrogen
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateNovember 16, 2023
FDA Product Classification

INGREDIENTS (1)

NITROGENActive
Quantity: 990 mL in 1 L
Code: N762921K75
Classification: ACTIB

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Nitrogen - FDA Drug Approval Details