Nitrogen

Product NDC: 71408-003
Requested package NDC: 71408-003-01
11-digit product format: 714080003
Labeler code: 71408
Product ID: 71408-003_6ba04b65-16ed-479e-b28b-973e61faf4e5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nitrogen
Dosage form: GAS
Route: RESPIRATORY (INHALATION)
Labeler: Ineos Pigments ASU LLC
Application: NDA211737
Marketing category: NDA
Marketing start: 2017-12-27
Substance: NITROGEN
Active strength: 99 L/100L
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
Ingredient	Strength
NITROGEN	99 L/100L

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
N762921K75	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
e2b7e83b-e1ba-446b-aff9-ff7050839eff	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71408-003-01	Nitrogen	10000 L in 1 TANK	GAS	10000		8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71408-003	NITROGEN GAS [INEOS PIGMENTS ASU LLC]	8	Current NDC, Legacy NDC, 1 package rows	20241029_e2b7e83b-e1ba-446b-aff9-ff7050839eff.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nitrogen	NITROGEN	Ineos Pigments ASU LLC	e2b7e83b-e1ba-446b-aff9-ff7050839eff	2024-10-27		Exact identifier application applno (NDA): 211737 application number: NDA211737 ndc (package): 71408-003-01 ndc (product): 71408-003 ndc11 (package): 71408000301

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
N762921K75	NITROGEN	7727-37-9	NITROGEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
311998	nitrogen 99 % Gas for Inhalation	PSN	e2b7e83b-e1ba-446b-aff9-ff7050839eff	8
311998	nitrogen 99 % Gas for Inhalation	SCD	e2b7e83b-e1ba-446b-aff9-ff7050839eff	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71408-003-01	71408000301	10000 L in 1 TANK (71408-003-01)	10000 l	2017-12-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nitrogen - Ineos Pigments ASU LLC	Ineos Pigments ASU LLC	2024-10-27	HUMAN PRESCRIPTION DRUG LABEL	8