NITROUS OXIDE

Manufacturer
Praxair Mexico, S. de R.L. de C.V
Effective date
2021-11-09
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 20:38:18

Label at a glance#

ProductNITROUS OXIDE
Active ingredientNITROUS OXIDE
Label structure1 sections

Label contents#

Full prescribing information#

NITROUS OXIDE USP LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRAXAIR              Praxair Mexico S. de, R.L. de C.V.

                                Laboraicarlo de Costrel de Calidad de Producto

                                Plasia Toluca

                                Av Independence Ote No 300

                                CP 50070 Toluca Ede de Mexico

                                Tel          (722)2358800

Certificate of Analysis (COA)

Customer Name:              Praxair Distribution Inc.

Date:     March 23 th, 2018                            COA US 0928

Shipping Container:  63273

Product:                                               Nitrous Oxide USP Medical Gas

Pharmaceutical form:                    Medicinal gas    

Purity:                                                  99.0 cmol/ mol Min.       Expiration Date:               March 23 th, 2020

DUNS:                                                   8129539029                         FDA Establishment Identifier: 3012518051

Batch Number:                 TCM-N20-MED-002-18

This product described in this document meets the requirements of the United States Pharmacopeia 39th edition 2016, Mexican United States Pharmacopeia, 11th edition 2014, Praxair Mexico, S. de R.L. de C.V. and Praxair Distribution, Inc.

Component                        Specification                     Test Procedure                 Results

Nitrous Oxide Purity        Min. 99.0 cmol/moi         Gas Chromatograph        99.84 cmol/mol

Carbon Monoxide            Max. 5.0 µmol/mol          Detector tube                    < 5 µmol/mol

Carbon Dioxide                 Max. 300.0 µmol/mol     Detector tube                    < 300 µmol/mol

Nitric Oxide                        Max. 1.0 µmol/mol          Detector tube                    < 1 µmol/mol

Nitrogen Dioxide              Max. 1.0 µmol/mol          Detector tube                    < 1 µmol/mol

Ammonia                            Max. 25.0 µmol/mol       Detector tube                    < 25 µmol/mol

Halogens                                                                            

(Chlorine)                            Max. 1.0 µmol/mol          Detector tube                    < 1 µmol/mol

Moisture                             Max. 100.0 ppm               Detector tube                    < 100 ppm

Capacitance

Air                                          Max 1.0 cmol/mol            Gas Chromatograph        0.16 cmol/mol

Identity                                Positive                                Gas Chromatograph        Positive

La concentracion esto expresada en unidades del Sistoma Internaciona La unidad µmol/mol

Es equivalente a porm y cmol/ mol es equivalente a %mol/mol.

The concentration is expressed in units of the International System. The unit µmol/mol are equivalent to ppm and cmol/mol are equivalent to % mol/mol.

Compliance with requirements:                Yes _X_ No ___

                                                                                                                                Reviewer’s Signature:

                                                                                ____________________________________________

                                                                                                QI. MYRNA VEONICA CRUZ MARTINEZ

                                                                                                Quality Control Responsible.

IMPORTANT The information here contained it has been prepared by expert personnel of Praxair Mexico by way of orientation toward the user. The suggested analytic Techniques have demonstrated a high dependability I their results, however, the use that is given to the information it is completely user user’s exclusive responsibility. This report cannot be reportability. This report cannot be reproduced without authorization of the Laboratory of Coontrol of Quality of Product of Praxair Mexidom, S. de, R.L. de C.V., Toluca Plants.

QQ/r-08-019/1 – P0270

Nitrous oxideNitrous oxide

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
312022nitrous oxide 99 % Gas for InhalationPSN5
312022nitrous oxide 99 % Gas for InhalationSCD5

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72223-001-012023-01-30C16284748780-1f386c649-daad-0266-e053-dadaa90a7c1aNitrous Oxide

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72223-001-01NITROUS OXIDE7064200 L in 1 CONTAINERGAS70642005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72223-001NITROUS OXIDE GAS [PRAXAIR MEXICO, S. DE R.L. DE C.V]5Legacy NDC, 1 package rows20211110_707ad554-2531-4457-bc80-7b835a48329c.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 1 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72223-00172223-001-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
NITROUS OXIDEK50XQU1029ACTIB

Source Document#

Source XML · Source PDF

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
97b2b0d9-a1f3-46b5-a0a4-ef68e66dcd6b707ad554-2531-4457-bc80-7b835a48329c2021-11-09Exact identifier
spl id: 97b2b0d9-a1f3-46b5-a0a4-ef68e66dcd6b
spl set id: 707ad554-2531-4457-bc80-7b835a48329c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.