Nitrous Oxide

Product NDC: 43621-003
11-digit product format: 436210003
Labeler code: 43621
Product ID: 43621-003_44713b93-5146-fa19-e063-6294a90a6cbd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nitrous Oxide
Dosage form: GAS
Route: RESPIRATORY (INHALATION)
Labeler: DJB Gas Services, Inc
Application: NDA205704
Marketing category: NDA
Marketing start: 2016-09-12
Substance: NITROUS OXIDE
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.

Additional Listing Data#

Finished product: Yes
Brand name base: Nitrous Oxide
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NITROUS OXIDE	990 mL/L

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
K50XQU1029	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
312022	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
403d8fa6-0c7a-4b87-a654-e0bb39c14327	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
43621-003-11	Nitrous Oxide	198 L in 1 CYLINDER	GAS	198	18
43621-003-12	Nitrous Oxide	255 L in 1 CYLINDER	GAS	255	18
43621-003-13	Nitrous Oxide	425 L in 1 CYLINDER	GAS	425	18
43621-003-14	Nitrous Oxide	708 L in 1 CYLINDER	GAS	708	18
43621-003-15	Nitrous Oxide	1133 L in 1 CYLINDER	GAS	1133	18
43621-003-16	Nitrous Oxide	1614 L in 1 CYLINDER	GAS	1614	18
43621-003-17	Nitrous Oxide	2265 L in 1 CYLINDER	GAS	2265	18
43621-003-18	Nitrous Oxide	3539 L in 1 CYLINDER	GAS	3539	18
43621-003-19	Nitrous Oxide	7108 L in 1 CYLINDER	GAS	7108	18
43621-003-20	Nitrous Oxide	9543 L in 1 CYLINDER	GAS	9543	18
43621-003-21	Nitrous Oxide	180 L in 1 DEWAR	GAS	180	18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43621-003	NITROUS OXIDE GAS [DJB GAS SERVICES, INC]	17	Current NDC, Legacy NDC, 11 package rows	20241023_403d8fa6-0c7a-4b87-a654-e0bb39c14327.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Join
Nitrous Oxide	NITROUS OXIDE	American Welding & Gas	07aa2a86-d01e-470f-a12c-9908118bedc6	2026-05-21	Exact identifier application applno (NDA): 205704 application number: NDA205704
Nitrous Oxide	NITROUS OXIDE	Machine & Welding Supply Company dba Arc3 Gases South	a5070767-c36a-4131-aa09-1bccfa24aa71	2025-12-02	Exact identifier application applno (NDA): 205704 application number: NDA205704
Nitrous Oxide	NITROUS OXIDE	General Air Service & Supply Co	b76cb73a-46f4-48d5-9f8d-b0872f2cfe2b	2025-11-26	Exact identifier application applno (NDA): 205704 application number: NDA205704
Nitrous Oxide	NITROUS OXIDE	DJB Gas Services, Inc	403d8fa6-0c7a-4b87-a654-e0bb39c14327	2025-11-25	Exact identifier application applno (NDA): 205704 application number: NDA205704 ndc (product): 43621-003
Nitrous Oxide	NITROUS OXIDE	Central Welding Supply Company	ccf22032-52df-4fa1-b514-963a3d46b62b	2025-10-28	Exact identifier application applno (NDA): 205704 application number: NDA205704
Nitrous Oxide	NITROUS OXIDE	Metro Welding Supply Corporation	8f95cb3b-195f-41df-8f96-6c11703612ef	2025-10-20	Exact identifier application applno (NDA): 205704 application number: NDA205704
NITROUS OXIDE	NITROUS OXIDE	Airtec Gases, LLC	00d2e785-1cdc-496d-abd3-b255ae1cb693	2025-10-13	Exact identifier application applno (NDA): 205704 application number: NDA205704
NITROUS OXIDE	NITROUS OXIDE	United States Welding, Inc.	8a791a86-caf1-4cdd-8c8d-235f8230a269	2024-10-29	Exact identifier application applno (NDA): 205704 application number: NDA205704

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
K50XQU1029	NITROUS OXIDE	10024-97-2	NITROUS OXIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
312022	nitrous oxide 99 % Gas for Inhalation	PSN	403d8fa6-0c7a-4b87-a654-e0bb39c14327	18
312022	nitrous oxide 99 % Gas for Inhalation	SCD	403d8fa6-0c7a-4b87-a654-e0bb39c14327	18

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43621-003-11	43621000311	198 L in 1 CYLINDER (43621-003-11)	198 l	2016-09-12	0000-00-00	No	No	Current
43621-003-12	43621000312	255 L in 1 CYLINDER (43621-003-12)	255 l	2016-09-12	0000-00-00	No	No	Current
43621-003-13	43621000313	425 L in 1 CYLINDER (43621-003-13)	425 l	2016-09-12	0000-00-00	No	No	Current
43621-003-14	43621000314	708 L in 1 CYLINDER (43621-003-14)	708 l	2016-09-12	0000-00-00	No	No	Current
43621-003-15	43621000315	1133 L in 1 CYLINDER (43621-003-15)	1133 l	2016-09-12	0000-00-00	No	No	Current
43621-003-16	43621000316	1614 L in 1 CYLINDER (43621-003-16)	1614 l	2016-09-12	0000-00-00	No	No	Current
43621-003-17	43621000317	2265 L in 1 CYLINDER (43621-003-17)	2265 l	2016-09-12	0000-00-00	No	No	Current
43621-003-18	43621000318	3539 L in 1 CYLINDER (43621-003-18)	3539 l	2016-09-12	0000-00-00	No	No	Current
43621-003-19	43621000319	7108 L in 1 CYLINDER (43621-003-19)	7108 l	2016-09-12	0000-00-00	No	No	Current
43621-003-20	43621000320	9543 L in 1 CYLINDER (43621-003-20)	9543 l	2016-09-12	0000-00-00	No	No	Current
43621-003-21	43621000321	180 L in 1 DEWAR (43621-003-21)	180 l	2016-09-12	0000-00-00	No	No	Current