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BAXFENDY

baxdrostat · Tablet, Film Coated

Prescription NDA RLD

Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information.

Overview

Brand name

BAXFENDY

Generic name

baxdrostat

Dosage form

Tablet, Film Coated

Route

Oral

Marketing category

NDA · NDA

Labeler

AstraZeneca Pharmaceuticals LP

Product type

Human Prescription Drug

DEA schedule

Not scheduled

Active ingredients

NDC product codes

Packages

Data completeness

54% of corroborating sources present

Active ingredients

Source: NDC Directory

Active ingredients and strengths as listed in the NDC Directory.
Ingredient	Strength	RxCUI	Monograph
Baxdrostat	1 mg/1	—	—
Baxdrostat	2 mg/1	—	—

Forms, strengths and routes

Source: NDC Directory

Dosage form

Tablet, Film Coated

Route of administration

Oral

Presentations

Regulatory status

Source: Drugs@FDA NDC Directory

Application number

219878

Application type

NDA · New Drug Application

Approval date

May 15, 2026

Sponsor

ASTRAZENECA AB

Products on application

Submissions recorded

Products approved under application 219878.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
219878-001	BAXFENDY	TABLET		BAXDROSTAT	Prescription	—	RLD
219878-002	BAXFENDY	TABLET		BAXDROSTAT	Prescription	—	RLD RS

Therapeutic equivalence

Source: Orange Book

TE code

—

Reference Listed Drug

Yes

Reference Standard

Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Patents and exclusivity

Source: Orange Book

Patent listings submitted under 21 U.S.C. 355(b)(1) and (c)(2).
Patent	Expires	Product	Substance	Use code	Submitted
9353081	February 4, 2033	001	Yes		June 4, 2026
9353081	February 4, 2033	002	Yes		June 4, 2026

Regulatory exclusivity periods.
Code	Expires	Product
NCE	May 15, 2031	001
NCE	May 15, 2031	002

Approval history

Source: Drugs@FDA

Most recent submissions on application 219878.
Type	No.	Action	Status	Date	Review
Original application	1	Type 1 - New Molecular Entity	Approved	May 15, 2026	Priority

Review documents

0 · Original application · June 15, 2026
0 · Original application · June 15, 2026
0 · Original application · May 19, 2026

Adverse event reports

Source: openFDA FAERS

FAERS reports mentioning this drug

as of 2026-09-25T03:42:24+00:00

A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Packaging and NDCs

Source: NDC Directory

Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC	Product NDC	Labeler	Description	Marketing start
0310-6001-30	0310-6001	AstraZeneca Pharmaceuticals LP	30 TABLET, FILM COATED in 1 BOTTLE (0310-6001-30)	May 15, 2026
0310-6001-95	0310-6001	AstraZeneca Pharmaceuticals LP	7 TABLET, FILM COATED in 1 BOTTLE (0310-6001-95)	May 15, 2026
0310-6002-30	0310-6002	AstraZeneca Pharmaceuticals LP	30 TABLET, FILM COATED in 1 BOTTLE (0310-6002-30)	May 15, 2026
0310-6002-95	0310-6002	AstraZeneca Pharmaceuticals LP	7 TABLET, FILM COATED in 1 BOTTLE (0310-6002-95)	May 15, 2026
0310-6001	0310-6001	AstraZeneca Pharmaceuticals LP	—	May 15, 2026
0310-6002	0310-6002	AstraZeneca Pharmaceuticals LP	—	May 15, 2026

Sources for this page

Every dataset that contributed a fact to this page.
Dataset	Agency	Used for
NDC Directory	FDA	Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA	FDA	Application, sponsor, submissions, review documents, marketing status
Orange Book	FDA	Therapeutic equivalence codes, reference drug flags, patents, exclusivity

Generated September 25, 2026 · 9 sections on this page.