Nitrogen

Product NDC: 33335-002
Requested package NDC: 33335-002-01
11-digit product format: 333350002
Labeler code: 33335
Product ID: 33335-002_eb4114b3-8d10-4a90-e053-2a95a90a95fd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nitrogen
Dosage form: GAS
Route: RESPIRATORY (INHALATION)
Labeler: WELSCO, INC.
Application: NDA205766
Marketing category: NDA
Marketing start: 2001-01-01
Marketing end: 0000-00-00
Substance: NITROGEN
Active strength: 990 mL/L
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	33335-002	33335-002-01	D	Discontinued by firm		2026-10-15

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.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
Nitrogen	ACTIVE INGREDIENT	N762921K75	NITROGEN GAS [WELSCO, INC.]	3
Nitrogen	ACTIVE MOIETY	N762921K75	NITROGEN GAS [WELSCO, INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
33335-002	NITROGEN GAS [WELSCO, INC.]	16	Legacy NDC	20241204_713aaf2d-05bb-401d-977b-31542720a55a.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
33335-002-01	33335000201	6513 L in 1 CYLINDER (33335-002-01)	6513 l	2001-01-01	0000-00-00	No	No	Current