Nitrogen

Product NDC: 10304-601
Requested package NDC: 10304-601-01
11-digit product format: 103040601
Labeler code: 10304
Product ID: 10304-601_43d0dedc-523b-fec5-e063-6294a90af2c7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nitrogen
Dosage form: GAS
Route: RESPIRATORY (INHALATION)
Labeler: Delille Oxygen Company
Application: NDA205866
Marketing category: NDA
Marketing start: 2000-06-12
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
b82f163b-c913-431d-88cf-8b6e08d1b42a	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
10304-601-01	Nitrogen	116495 L in 1 DEWAR	GAS	116495	14
10304-601-02	Nitrogen	114739 L in 1 DEWAR	GAS	114739	14
10304-601-03	Nitrogen	6512 L in 1 CYLINDER	GAS	6512	14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
Nitrogen	ACTIVE INGREDIENT	N762921K75	NITROGEN GAS [DELILLE OXYGEN COMPANY]	2
Nitrogen	ACTIVE MOIETY	N762921K75	NITROGEN GAS [DELILLE OXYGEN COMPANY]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10304-601	NITROGEN GAS [DELILLE OXYGEN COMPANY]	13	Current NDC, Legacy NDC, 3 package rows	20241023_b82f163b-c913-431d-88cf-8b6e08d1b42a.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
348987	nitrogen 99.9 % Gas for Inhalation	PSN	b82f163b-c913-431d-88cf-8b6e08d1b42a	14
348987	nitrogen 99.9 % Gas for Inhalation	SCD	b82f163b-c913-431d-88cf-8b6e08d1b42a	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
10304-601-01	10304060101	116495 L in 1 DEWAR (10304-601-01)	116495 l	2000-06-12	0000-00-00	No	No	Current