BAXFENDY Ref.[116676] Active ingredients:

Source: FDA, National Drug Code (US)  Revision Year: 2026 

Product description

Baxdrostat is an aldosterone synthase inhibitor. The chemical name of baxdrostat is N-[(8R)-4-(1-methyl-2-oxo-1,2,3,4-tetrahydro-6-quinolinyl)-5,6,7,8-tetrahydro-8-isoquinolinyl]propanamide. The molecular formula is C22H25N3O2 and the molecular weight is 363.45 g/mol. The structural formula is:

BAXFENDY is available as a film-coated tablet for oral administration, containing 1 mg or 2 mg of baxdrostat. The inactive ingredients in BAXFENDY are croscarmellose sodium, lactose anhydrous, magnesium stearate, and microcrystalline cellulose. The film coating contains the following inactive ingredients: polyethylene glycol 3350, polyvinyl alcohol, talc, and titanium dioxide, in addition to ferric oxide red (1 mg strength tablets) or ferric oxide yellow (2 mg strength tablets).

Dosage Forms and Strengths

BAXFENDY is available as film-coated tablets:

  • 1 mg pink, biconvex, round, film-coated tablets with "BX" debossed on one side and "1" on the other side.
  • 2 mg yellow, biconvex, round, film-coated tablets with "BX" debossed on one side and "2" on the other side.
How Supplied

BAXFENDY (baxdrostat) tablets are available in the strengths and packages listed in Table 3.

Table 3. BAXFENDY Tablet Presentations:

StrengthDescriptionPackage TypePackage Size and NDC Number
1 mgPink, biconvex, round, film-coated
tablets with "BX" debossed on one
side and "1" on the other side		HDPE bottle with
desiccant and child-
resistant closure		30‑count: 0310-6001-30
2 mgYellow, biconvex, round, film-coated
tablets with "BX" debossed on one
side and "2" on the other side		HDPE bottle with
desiccant and child-
resistant closure		30-count: 0310-6002-30

Distributed by: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850

Drugs

Drug Countries
BAXFENDY United States
 
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