FDA.reportPublic FDA data

BAXFENDY

Product NDC
0310-6001
Requested package NDC
0310-6001-95
11-digit product format
003106001
Labeler code
0310
Product ID
0310-6001_0d936683-669c-4e75-8760-29a07c8c4dc3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
baxdrostat
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AstraZeneca Pharmaceuticals LP
Application
NDA219878
Marketing category
NDA
Marketing start
2026-05-15
Substance
BAXDROSTAT
Active strength
1 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N219878-001BAXFENDYBAXDROSTAT1MGTABLET / ORALRLD2026-05-15
N219878-002BAXFENDYBAXDROSTAT2MGTABLET / ORALRLD, RS2026-05-15

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N219878-00193530812033-02-04Drug substance, Drug product2026-06-04
N219878-00293530812033-02-04Drug substance, Drug product2026-06-04

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N219878-001NCE2031-05-15
N219878-002NCE2031-05-15

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219878-001BAXFENDY1MGTABLET / ORALRLD2026-05-15a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219878-002BAXFENDY2MGTABLET / ORALRLD, RS2026-05-15a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219878-00193530812033-02-04Drug substance, Drug product2026-06-04a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219878-00293530812033-02-04Drug substance, Drug product2026-06-04a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219878-001NCE2031-05-15a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219878-002NCE2031-05-15a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
BAXFENDY
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BAXDROSTAT1 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
NF3P9Z8J5YInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2743403Internal RxNorm lookup
2743409Internal RxNorm lookup
2743411Internal RxNorm lookup
2743413Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b1fc1ee7-facc-4099-b3db-a4c1daeaa4beAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0310-6001-30BAXFENDY30 in 1 BOTTLETABLET, FILM COATED302
0310-6001-95BAXFENDY7 in 1 BOTTLETABLET, FILM COATED72

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BAXFENDYBAXDROSTATAstraZeneca Pharmaceuticals LPb1fc1ee7-facc-4099-b3db-a4c1daeaa4be2026-05-15Warnings, Adverse reactionsExact identifier
application applno (NDA): 219878
application number: NDA219878
ndc (package): 0310-6001-95
ndc (product): 0310-6001
ndc11 (package): 00310600195

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2743403baxdrostat 1 MG Oral TabletPSNb1fc1ee7-facc-4099-b3db-a4c1daeaa4be2
2743411baxdrostat 2 MG Oral TabletPSNb1fc1ee7-facc-4099-b3db-a4c1daeaa4be2
2743409BAXFENDY 1 MG Oral TabletPSNb1fc1ee7-facc-4099-b3db-a4c1daeaa4be2
2743413BAXFENDY 2 MG Oral TabletPSNb1fc1ee7-facc-4099-b3db-a4c1daeaa4be2
2743409baxdrostat 1 MG Oral Tablet [Baxfendy]SBDb1fc1ee7-facc-4099-b3db-a4c1daeaa4be2
2743413baxdrostat 2 MG Oral Tablet [Baxfendy]SBDb1fc1ee7-facc-4099-b3db-a4c1daeaa4be2
2743403baxdrostat 1 MG Oral TabletSCDb1fc1ee7-facc-4099-b3db-a4c1daeaa4be2
2743411baxdrostat 2 MG Oral TabletSCDb1fc1ee7-facc-4099-b3db-a4c1daeaa4be2
2743409Baxfendy 1 MG Oral TabletSYb1fc1ee7-facc-4099-b3db-a4c1daeaa4be2
2743413Baxfendy 2 MG Oral TabletSYb1fc1ee7-facc-4099-b3db-a4c1daeaa4be2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0310-6001-95003106001957 TABLET, FILM COATED in 1 BOTTLE (0310-6001-95) 2026-05-15YesNoCurrent