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Nitrogen

Nitrogen

Approved
Approval ID

da044445-31cc-477e-92f8-88d6e3ec5eff

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 31, 2024

Manufacturers
FDA

American Welding & Gas

DUNS: 068181965

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 Code44076-006
Application NumberNDA205839
Product Classification
M
Marketing Category
C73594
G
Generic Name
Nitrogen
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateJanuary 31, 2024
FDA Product Classification

INGREDIENTS (1)

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

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 1/31/2024

NITROGEN, COMPRESSED NF

UN1066

CONTENTS

CYLINDER TYPE CU. FT. LITERS CYLINDER TYPE CU. FT. LITERS

T 275 7801 G 34 957

K 207 5863 E 23 643

M 107 303

MEDICAL NITROGEN, NF

WARNING: Rx only. Administration of Nitrogen may be hazardous or contraindicated. For use only by or under the supervision of a licensed practitioner who is experienced in the use and administration of Nitrogen and is familiar with the indications, effects, dosages, methods, and frequency, and duration of administration, and with the hazards, contraindications and side effects, and the precautions to be taken.

WARNING: CONTAINS GAS UNDER PRESSURE; MAY EXPLODE IF HEATED. MAY DISPLACE OXYGEN AND CAUSE RAPID SUFFOCATION. Do not handle until all safety precautions have been read and understood. Use and store only outdoors or in a well- ventilated place. Protect from sunlight when ambient temperature exceeds 52 C (125 F). Use a back flow preventive device in the piping. Close after each use and when empty. Use only with equipment rated for cylinder pressure. Do not open valve until connected to equipment prepared for use. Read and follow the Safety Data Sheet (SDS) before use.

FIRST AID: IF INHALED: Remove person to fresh air and keep comfortable for breathing. Get medical advice/attention.

CAS: 7727-37-9

DO NOT REMOVE THIS PRODUCT LABEL.

AWG

American Welding & Gas, Inc.

4900 Falls of Neuse Road, Suite 150

Raleigh, NC 27609

800-967-6874 nitrogen two louisville ky

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