Approvals (Drugs@FDA)

FIDAXOMICIN

SANDOZ · FIDAXOMICIN

ANDA220465Generic (ANDA)Prescription
Open FDA's page for this record
Application number
ANDA220465
Sponsor name
SANDOZ
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20260813
    Review priority
    STANDARD
    Submission class code
    UNKNOWN
Products
  1. Product number
    001
    Reference drug
    No
    Brand name
    FIDAXOMICIN
    Reference standard
    No
    Dosage form
    TABLET
    Route
    ORAL
    Marketing status
    Prescription
    Te code
    AB
    Active ingredients
    1. Name
      FIDAXOMICIN
      Strength
      200MG
Harmonized identifiers (openFDA)
Application number
ANDA220465
Brand name
FIDAXOMICIN
Generic name
FIDAXOMICIN
Manufacturer name
Sandoz Inc
Product NDC
0781-5194
Product type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Substance name
FIDAXOMICIN
RxCUI
1111106
SPL ID
5e8ad2f1-a227-4171-9b66-cd6ce49b8baa
SPL set ID
5e8ad2f1-a227-4171-9b66-cd6ce49b8baa
Package NDC
0781-5194-20
Nui
M0028311, N0000175431
Pharm class cs
Macrolides [CS]
Pharm class epc
Macrolide Antibacterial [EPC]
UNII
Z5N076G8YQ
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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.