FDA.reportPublic FDA data

Carbon Dioxide

Product NDC
63961-010
Requested package NDC
63961-010-11
11-digit product format
639610010
Labeler code
63961
Product ID
63961-010_eb3d2ab5-5a26-272a-e053-2995a90a778a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Carbon Dioxide
Dosage form
GAS
Route
RESPIRATORY (INHALATION)
Labeler
Middlesex Gases & Technologies, Inc.
Application
NDA216614
Marketing category
NDA
Marketing start
2022-01-10
Marketing end
0000-00-00
Substance
CARBON DIOXIDE
Active strength
998 mL/L
Pharmacologic classes
Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63961-01063961-010-11IInactivated by FDA2026-10-05

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.

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
63961-010-01Carbon Dioxide
63961-010-02Carbon Dioxide
63961-010-03Carbon Dioxide
63961-010-04Carbon Dioxide
63961-010-05Carbon Dioxide
63961-010-06Carbon Dioxide
63961-010-07Carbon Dioxide
63961-010-08Carbon Dioxide
63961-010-09Carbon Dioxide
63961-010-10Carbon Dioxide
63961-010-11Carbon Dioxide
63961-010-12Carbon Dioxide
63961-010-13Carbon Dioxide
63961-010-14Carbon Dioxide

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63961-010-01Carbon Dioxide1.134 L in 1 CYLINDERGAS1.1344
63961-010-02Carbon Dioxide2.268 L in 1 CYLINDERGAS2.2684
63961-010-03Carbon Dioxide4.536 L in 1 CYLINDERGAS4.5364
63961-010-04Carbon Dioxide6.804 L in 1 CYLINDERGAS6.8044
63961-010-05Carbon Dioxide9.072 L in 1 CYLINDERGAS9.0724
63961-010-06Carbon Dioxide13.608 L in 1 CYLINDERGAS13.6084
63961-010-07Carbon Dioxide22.68 L in 1 CYLINDERGAS22.684
63961-010-08Carbon Dioxide34.02 L in 1 CYLINDERGAS34.024
63961-010-09Carbon Dioxide45.36 L in 1 CYLINDERGAS45.364
63961-010-10Carbon Dioxide160 L in 1 DEWARGAS1604
63961-010-11Carbon Dioxide180 L in 1 DEWARGAS1804
63961-010-12Carbon Dioxide200 L in 1 DEWARGAS2004
63961-010-13Carbon Dioxide230 L in 1 DEWARGAS2304
63961-010-14Carbon Dioxide265 L in 1 DEWARGAS2654

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63961-010CARBON DIOXIDE GAS [MIDDLESEX GASES & TECHNOLOGIES, INC.]4Legacy NDC, 14 package rows20241109_d5f5156a-b770-2835-e053-2995a90a9543.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
347024carbon dioxide 99.8 % Gas for InhalationPSNd5f5156a-b770-2835-e053-2995a90a95434
347024carbon dioxide 99.8 % Gas for InhalationSCDd5f5156a-b770-2835-e053-2995a90a95434

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63961-010-1163961001011180 L in 1 DEWAR (63961-010-11) 180 l2022-01-100000-00-00NoNoCurrent