FDA.reportPublic FDA data

Nitrogen

Product NDC
53452-002
11-digit product format
534520002
Labeler code
53452
Product ID
53452-002_4472221c-8211-58a6-e063-6394a90a8293
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Nitrogen
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
Dale Oxygen And Acetylene Service, Inc
Application
NDA205766
Marketing category
NDA
Marketing start
1963-01-01
Substance
NITROGEN
Active strength
990 mL/L
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog.

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Nitrogen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NITROGEN990 mL/L

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
N762921K75Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
311998Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b4d03108-9837-495b-bf0d-2bb929cb7e39Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53452-002-01Nitrogen850 L in 1 CYLINDERGAS85012
53452-002-02Nitrogen6453 L in 1 CYLINDERGAS645312
53452-002-03Nitrogen643 L in 1 CYLINDERGAS64312
53452-002-04Nitrogen1699 L in 1 CYLINDERGAS169912
53452-002-05Nitrogen160 L in 1 DEWARGAS16012
53452-002-06Nitrogen120 L in 1 DEWARGAS12012
53452-002-07Nitrogen80 L in 1 DEWARGAS8012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53452-002NITROGEN GAS [DALE OXYGEN AND ACETYLENE SERVICE, INC]11Current NDC, Legacy NDC, 7 package rows20241023_b4d03108-9837-495b-bf0d-2bb929cb7e39.zip

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 3 of 3 · 41 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NITROGENNITROGENADF Welding & Medical, Inc.174cb8ea-66fb-4d0b-920f-01fba9537ee92024-10-02Exact identifier
application applno (NDA): 205766
application number: NDA205766

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311998nitrogen 99 % Gas for InhalationPSNb4d03108-9837-495b-bf0d-2bb929cb7e3912
311998nitrogen 99 % Gas for InhalationSCDb4d03108-9837-495b-bf0d-2bb929cb7e3912

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53452-002-0153452000201850 L in 1 CYLINDER (53452-002-01) 850 l1963-01-010000-00-00NoNoCurrent
53452-002-02534520002026453 L in 1 CYLINDER (53452-002-02) 6453 l1963-01-010000-00-00NoNoCurrent
53452-002-0353452000203643 L in 1 CYLINDER (53452-002-03) 643 l1963-01-010000-00-00NoNoCurrent
53452-002-04534520002041699 L in 1 CYLINDER (53452-002-04) 1699 l1963-01-010000-00-00NoNoCurrent
53452-002-0553452000205160 L in 1 DEWAR (53452-002-05) 160 l1963-01-010000-00-00NoNoCurrent
53452-002-0653452000206120 L in 1 DEWAR (53452-002-06) 120 l1963-01-010000-00-00NoNoCurrent
53452-002-075345200020780 L in 1 DEWAR (53452-002-07) 80 l1963-01-010000-00-00NoNoCurrent