Approvals (Drugs@FDA)

CARBON DIOXIDE, USP

MITCHELL WEDLING SUPPLY · CARBON DIOXIDE

NDA220461Drug (NDA)Prescription
Open FDA's page for this record
Application number
NDA220461
Sponsor name
MITCHELL WEDLING SUPPLY
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20250421
    Review priority
    UNKNOWN
    Submission class code
    UNKNOWN
    Application docs
    1. ID
      82204
      Url
      http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/220461Orig1s000MGLtr.pdf
      Date
      20250519
      Type
      Letter
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    CARBON DIOXIDE, USP
    Reference standard
    No
    Dosage form
    GAS
    Route
    INHALATION
    Marketing status
    Prescription
    Active ingredients
    1. Name
      CARBON DIOXIDE
Harmonized identifiers (openFDA)
Application number
NDA220461
Brand name
CARBON DIOXIDE
Generic name
CARBON DIOXIDE
Manufacturer name
MITCHELL WELDING SUPPLY DBA Meritus Texas
Product NDC
72276-004
Product type
HUMAN PRESCRIPTION DRUG
Route
RESPIRATORY (INHALATION)
Substance name
CARBON DIOXIDE
RxCUI
309004
SPL ID
4dc96547-35e8-4d89-e063-6294a90a5ee9
SPL set ID
35061f51-65ed-74de-e063-6294a90abb1f
Package NDC
72276-004-01, 72276-004-02, 72276-004-03, 72276-004-04, 72276-004-05
Nui
N0000180185, N0000010258
Pharm class epc
Radiographic Contrast Agent [EPC]
Pharm class moa
X-Ray Contrast Activity [MoA]
UNII
142M471B3J
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.