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Carbon Dioxide/Oxygen Mix

carbon dioxide/oxygen mix

Approved
Approval ID

6b000266-aa36-4b0f-b4d1-f38e59d35c61

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 16, 2023

Manufacturers
FDA

NEXAIR, LLC

DUNS: 927024422

Products 1

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

Carbon Dioxide/Oxygen Mix

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code12213-800
Application NumberNDA205849
Product Classification
M
Marketing Category
C73594
G
Generic Name
Carbon Dioxide/Oxygen Mix
Product Specifications
Route of AdministrationRESPIRATORY (INHALATION)
Effective DateNovember 16, 2023
FDA Product Classification

INGREDIENTS (2)

OXYGENActive
Quantity: 50 mL in 1 L
Code: S88TT14065
Classification: ACTIB
CARBON DIOXIDEInactive
Quantity: 950 mL in 1 L
Code: 142M471B3J
Classification: IACT

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Carbon Dioxide/Oxygen Mix - FDA Drug Approval Details