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Nitrous Oxide

Nitrous Oxide-007

Approved
Approval ID

aaa2ed08-c5cb-4d46-917b-ce1a9d0ce462

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 16, 2023

Manufacturers
FDA

Roberts Oxygen Company, Inc.

DUNS: 042646877

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Nitrous Oxide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code46123-007
Application NumberNDA206009
Product Classification
M
Marketing Category
C73594
G
Generic Name
Nitrous Oxide
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateNovember 16, 2023
FDA Product Classification

INGREDIENTS (1)

NITROUS OXIDEActive
Quantity: 990 mL in 1 L
Code: K50XQU1029
Classification: ACTIB

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Nitrous Oxide - FDA Drug Approval Details