Nitrogen

Product NDC: 81681-002
11-digit product format: 816810002
Labeler code: 81681
Product ID: 81681-002_4586f7f4-0c31-5b31-e063-6294a90acd33
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nitrogen
Dosage form: GAS
Route: RESPIRATORY (INHALATION)
Labeler: WEST PENN LACO, INC.
Application: NDA205766
Marketing category: NDA
Marketing start: 2021-03-09
Substance: NITROGEN
Active strength: 999 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
Ingredient	Strength
NITROGEN	999 mL/L

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
348987	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
bd201f32-444c-304d-e053-2a95a90ad940	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
81681-002-01	Nitrogen	6512.9 L in 1 CYLINDER	GAS	6512.9		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
81681-002	NITROGEN GAS [WEST PENN LACO, INC.]	6	Current NDC, Legacy NDC, 1 package rows	20241204_bd201f32-444c-304d-e053-2a95a90ad940.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NITROGEN	NITROGEN	ADF Welding & Medical, Inc.	174cb8ea-66fb-4d0b-920f-01fba9537ee9	2024-10-02		Exact identifier application applno (NDA): 205766 application number: NDA205766

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
348987	nitrogen 99.9 % Gas for Inhalation	PSN	bd201f32-444c-304d-e053-2a95a90ad940	7
348987	nitrogen 99.9 % Gas for Inhalation	SCD	bd201f32-444c-304d-e053-2a95a90ad940	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
81681-002-01	81681000201	6512.9 L in 1 CYLINDER (81681-002-01)	6512.9 l	2021-03-09	0000-00-00	No	No	Current