Approvals (Drugs@FDA)

ZENBEXUS

BRISTOL MYERS SQUIBB · IBERDOMIDE HYDROCHLORIDE

NDA221075Drug (NDA)Prescription
Open FDA's page for this record
Application number
NDA221075
Sponsor name
BRISTOL MYERS SQUIBB
Submissions
  1. Submission type
    ORIG
    Submission number
    1
    Submission status
    AP
    Submission status date
    20260813
    Review priority
    PRIORITY
    Submission class code
    TYPE 1
    Submission class code description
    Type 1 - New Molecular Entity
    Submission property type
    1. Code
      Orphan
    Application docs
    1. ID
      86908
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/221075Orig1s000ltr.pdf
      Date
      20260817
      Type
      Letter
    2. ID
      86957
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/221075Orig1s000lbl.pdf
      Date
      20260818
      Type
      Label
    3. ID
      86958
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/221075Orig1s000lbl.pdf#page=25
      Date
      20260818
      Type
      Medication Guide
    4. ID
      87280
      Url
      https://www.accessdata.fda.gov/drugsatfda_docs/nda/2026/221075Orig1s000TOC.html
      Date
      20260925
      Type
      Review
Products
  1. Product number
    002
    Reference drug
    Yes
    Brand name
    ZENBEXUS
    Reference standard
    Yes
    Dosage form
    CAPSULE
    Route
    ORAL
    Marketing status
    Prescription
    Active ingredients
    1. Name
      IBERDOMIDE HYDROCHLORIDE
      Strength
      EQ 1MG BASE
  2. Product number
    001
    Reference drug
    Yes
    Brand name
    ZENBEXUS
    Reference standard
    No
    Dosage form
    CAPSULE
    Route
    ORAL
    Marketing status
    Prescription
    Active ingredients
    1. Name
      IBERDOMIDE HYDROCHLORIDE
      Strength
      EQ 0.75MG BASE
Harmonized identifiers (openFDA)
Application number
NDA221075
Brand name
ZENBEXUS
Generic name
IBERDOMIDE
Manufacturer name
E.R. Squibb & Sons, L.L.C.
Product NDC
0003-5700, 0003-5710
Product type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Substance name
IBERDOMIDE HYDROCHLORIDE
RxCUI
2749737, 2749743, 2749745, 2749747
SPL ID
05b6e27f-40ba-4939-a0c3-8e8ae1feae98
SPL set ID
3663d9cb-3f66-48ae-bf0a-6958bc0888de
Package NDC
0003-5700-21, 0003-5710-21
UNII
79L3645KFI
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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.