Nitrogen

Product NDC: 52695-003
Requested package NDC: 52695-003-01
11-digit product format: 526950003
Labeler code: 52695
Product ID: 52695-003_45845cbf-740a-45c4-e063-6394a90aa0ce
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nitrogen
Dosage form: GAS
Route: RESPIRATORY (INHALATION)
Labeler: Humphries, Inc.
Application: NDA205866
Marketing category: NDA
Marketing start: 2018-01-01
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
Ingredient	Strength
NITROGEN	990 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
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
9af0b870-0df6-9692-e053-2995a90ac5ab	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
52695-003-01	Nitrogen	396.43 L in 1 CYLINDER	GAS	396.43	7
52695-003-02	Nitrogen	651.29 L in 1 CYLINDER	GAS	651.29	7
52695-003-03	Nitrogen	1557.43 L in 1 CYLINDER	GAS	1557.43	7
52695-003-04	Nitrogen	2152.08 L in 1 CYLINDER	GAS	2152.08	7
52695-003-05	Nitrogen	3256.44 L in 1 CYLINDER	GAS	3256.44	7
52695-003-06	Nitrogen	6512.87 L in 1 CYLINDER	GAS	6512.87	7
52695-003-07	Nitrogen	160 L in 1 DEWAR	GAS	160	7
52695-003-08	Nitrogen	180 L in 1 DEWAR	GAS	180	7
52695-003-09	Nitrogen	200 L in 1 DEWAR	GAS	200	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52695-003	NITROGEN GAS [HUMPHRIES, INC.]	6	Current NDC, Legacy NDC, 9 package rows	20241102_9af0b870-0df6-9692-e053-2995a90ac5ab.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 · 22 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NITROGEN	NITROGEN	Air Source Industries Inc	830d7d78-afa8-49bc-8c00-4d66eb72b83c	2024-10-06		Exact identifier application applno (NDA): 205866 application number: NDA205866
Nitrogen	NITROGEN	Air Products and Chemicals, Inc.	e4c5b56e-4c06-4980-8669-6df35e240bf9	2018-12-14		Exact identifier application applno (NDA): 205866 application number: NDA205866

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	9af0b870-0df6-9692-e053-2995a90ac5ab	7
311998	nitrogen 99 % Gas for Inhalation	SCD	9af0b870-0df6-9692-e053-2995a90ac5ab	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52695-003-01	52695000301	396.43 L in 1 CYLINDER (52695-003-01)	396.43 l	2018-01-01	0000-00-00	No	No	Current