40% Oxygen/Nitrogen Mix

Product NDC
12213-200
11-digit product format
122130200
Labeler code
12213
Product ID
12213-200_42793f6c-11ff-0d90-e063-6294a90ad705
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
40% Oxygen/Nitrogen Mix
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
NexAir LLC
Application
NDA205865
Marketing category
NDA
Marketing start
2020-04-09
Substance
OXYGEN
Active strength
400 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
40% Oxygen/Nitrogen Mix
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYGEN400 mL/L

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
S88TT14065Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
348544Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a2e01d9b-4728-6893-e053-2995a90ab8e5Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12213-200-0140% Oxygen/Nitrogen Mix5984 L in 1 CYLINDERGAS59847

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12213-20040% OXYGEN/NITROGEN MIX GAS [NEXAIR LLC]6Current NDC, Legacy NDC, 1 package rows20241114_a2e01d9b-4728-6893-e053-2995a90ab8e5.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 2 of 2 · 31 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OxygenOXYGENVirtAir Inc.beaf65dd-337d-4696-87c7-3237c7eec8fe2025-10-27Exact identifier
application applno (NDA): 205865
application number: NDA205865
OXYGENOXYGENRegional Home Care, Inc.7e5fe6ed-ddfa-4735-a65a-2d26cdc532ba2025-10-24Exact identifier
application applno (NDA): 205865
application number: NDA205865
OxygenOXYGENDepke Welding Supplies, Inc.e81305b1-798d-4e16-8144-f96be15bdaf02025-10-21Exact identifier
application applno (NDA): 205865
application number: NDA205865
OxygenOXYGENCONROE WELDING SUPPLY, INC.eb00b701-1d4b-39a7-e053-2a95a90af1c32025-10-09Exact identifier
application applno (NDA): 205865
application number: NDA205865
OxygenOXYGENGallup Welders Supply, Inc.d3b0a4c1-dd5e-4176-8560-09f392cb4b062025-10-06Exact identifier
application applno (NDA): 205865
application number: NDA205865
OxygenOXYGENEarlbeck Welding Suppliesc627c7c7-7a20-4413-bcb8-179fcfa2f2f02025-10-06Exact identifier
application applno (NDA): 205865
application number: NDA205865
OXYGENOXYGENRespiratory Care Partners, Incdc8d38dc-06de-4434-9f9c-8d7e76f815db2024-10-28Exact identifier
application applno (NDA): 205865
application number: NDA205865
OXYGENOXYGENAtlas Welding Supply Co Inc82baf417-8417-4df8-89d3-9d9f0e6382f22024-10-11Exact identifier
application applno (NDA): 205865
application number: NDA205865
AIR COMPRESSEDAIR COMPRESSEDAir Source Industriesf99447d4-50a3-437c-9754-f0945ede368a2024-10-06Exact identifier
application applno (NDA): 205865
application number: NDA205865
OXYGEN0XYGENAir Source Industries Incdbec9c5c-4656-4238-861a-986e8bd10e532024-10-06Exact identifier
application applno (NDA): 205865
application number: NDA205865
OxygenOXYGENAir Products and Chemicals, Inc.3d0d7bdd-28d9-43d4-827c-4f6f4df6a8bc2016-08-11Exact identifier
application applno (NDA): 205865
application number: NDA205865

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
348544nitrogen 60 % / oxygen 40 % Gas for InhalationPSNa2e01d9b-4728-6893-e053-2995a90ab8e57
348544nitrogen 60 % / oxygen 40 % Gas for InhalationSCDa2e01d9b-4728-6893-e053-2995a90ab8e57

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
12213-200-01122130200015984 L in 1 CYLINDER (12213-200-01) 5984 l2020-04-090000-00-00NoNoCurrent