Brexpiprazole

Product NDC
27241-207
11-digit product format
272410207
Labeler code
27241
Product ID
27241-207_430dc8c4-7349-42d5-9036-b0bdcc02a839
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Brexpiprazole
Dosage form
TABLET
Route
ORAL
Labeler
Ajanta Pharma USA Inc.
Application
ANDA213718
Marketing category
ANDA
Marketing start
2023-02-03
Substance
BREXPIPRAZOLE
Active strength
2 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
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 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A213718-001BREXPIPRAZOLEBREXPIPRAZOLE0.25MGTABLET / ORAL2023-02-03
A213718-002BREXPIPRAZOLEBREXPIPRAZOLE0.5MGTABLET / ORAL2023-02-03
A213718-003BREXPIPRAZOLEBREXPIPRAZOLE1MGTABLET / ORAL2023-02-03
A213718-004BREXPIPRAZOLEBREXPIPRAZOLE2MGTABLET / ORAL2023-02-03
A213718-005BREXPIPRAZOLEBREXPIPRAZOLE3MGTABLET / ORAL2023-02-03
A213718-006BREXPIPRAZOLEBREXPIPRAZOLE4MGTABLET / ORAL2023-02-03

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.

Product history page 1 of 4 · 138 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A213718-001BREXPIPRAZOLE0.25MGTABLET / ORAL2023-02-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213718-002BREXPIPRAZOLE0.5MGTABLET / ORAL2023-02-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213718-003BREXPIPRAZOLE1MGTABLET / ORAL2023-02-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213718-004BREXPIPRAZOLE2MGTABLET / ORAL2023-02-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213718-005BREXPIPRAZOLE3MGTABLET / ORAL2023-02-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213718-006BREXPIPRAZOLE4MGTABLET / ORAL2023-02-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213718-001BREXPIPRAZOLE0.25MGTABLET / ORAL2023-02-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213718-002BREXPIPRAZOLE0.5MGTABLET / ORAL2023-02-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213718-003BREXPIPRAZOLE1MGTABLET / ORAL2023-02-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213718-004BREXPIPRAZOLE2MGTABLET / ORAL2023-02-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213718-005BREXPIPRAZOLE3MGTABLET / ORAL2023-02-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213718-006BREXPIPRAZOLE4MGTABLET / ORAL2023-02-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A213718-001BREXPIPRAZOLE0.25MGTABLET / ORAL2023-02-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213718-002BREXPIPRAZOLE0.5MGTABLET / ORAL2023-02-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213718-003BREXPIPRAZOLE1MGTABLET / ORAL2023-02-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213718-004BREXPIPRAZOLE2MGTABLET / ORAL2023-02-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213718-005BREXPIPRAZOLE3MGTABLET / ORAL2023-02-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213718-006BREXPIPRAZOLE4MGTABLET / ORAL2023-02-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213718-001BREXPIPRAZOLE0.25MGTABLET / ORAL2023-02-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213718-002BREXPIPRAZOLE0.5MGTABLET / ORAL2023-02-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213718-003BREXPIPRAZOLE1MGTABLET / ORAL2023-02-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213718-004BREXPIPRAZOLE2MGTABLET / ORAL2023-02-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213718-005BREXPIPRAZOLE3MGTABLET / ORAL2023-02-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213718-006BREXPIPRAZOLE4MGTABLET / ORAL2023-02-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213718-001BREXPIPRAZOLE0.25MGTABLET / ORAL2023-02-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213718-002BREXPIPRAZOLE0.5MGTABLET / ORAL2023-02-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213718-003BREXPIPRAZOLE1MGTABLET / ORAL2023-02-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213718-004BREXPIPRAZOLE2MGTABLET / ORAL2023-02-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213718-005BREXPIPRAZOLE3MGTABLET / ORAL2023-02-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213718-006BREXPIPRAZOLE4MGTABLET / ORAL2023-02-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213718-001BREXPIPRAZOLE0.25MGTABLET / ORAL2023-02-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213718-002BREXPIPRAZOLE0.5MGTABLET / ORAL2023-02-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213718-003BREXPIPRAZOLE1MGTABLET / ORAL2023-02-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213718-004BREXPIPRAZOLE2MGTABLET / ORAL2023-02-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213718-005BREXPIPRAZOLE3MGTABLET / ORAL2023-02-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213718-006BREXPIPRAZOLE4MGTABLET / ORAL2023-02-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213718-001BREXPIPRAZOLE0.25MGTABLET / ORAL2023-02-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213718-002BREXPIPRAZOLE0.5MGTABLET / ORAL2023-02-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213718-003BREXPIPRAZOLE1MGTABLET / ORAL2023-02-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213718-004BREXPIPRAZOLE2MGTABLET / ORAL2023-02-032680178bc6a6…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A213718-001AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A213718-002AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A213718-003AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A213718-004AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A213718-005AB1a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A213718-006AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A213718-001AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A213718-002AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A213718-003AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A213718-004AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A213718-005AB13f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A213718-006AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A213718-001AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A213718-002AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A213718-003AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A213718-004AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A213718-005AB1053a50430f4f…
2023-05-13 08:27 UTC2023-05A213718-006AB1053a50430f4f…

Additional Listing Data#

Finished product
Yes
Brand name base
Brexpiprazole
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BREXPIPRAZOLE2 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2J3YBM1K8CInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1658319Internal RxNorm lookup
1658327Internal RxNorm lookup
1658331Internal RxNorm lookup
1658335Internal RxNorm lookup
1658339Internal RxNorm lookup
1658343Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
993b584c-7fe6-4551-899f-39146c8508acAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4f98ce54-9f30-4e8a-8455-2d3e352e5314Product name220251106

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
27241-207-30Brexpiprazole30 in 1 BOTTLETABLET304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27241-207BREXPIPRAZOLE TABLET [AJANTA PHARMA USA INC.]4Current NDC, 1 package rows20230222_993b584c-7fe6-4551-899f-39146c8508ac.zip

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
BrexpiprazoleBREXPIPRAZOLEAjanta Pharma USA Inc.993b584c-7fe6-4551-899f-39146c8508ac2022-12-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213718
application number: ANDA213718
ndc (product): 27241-207

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1658319brexpiprazole 0.25 MG Oral TabletPSN993b584c-7fe6-4551-899f-39146c8508ac4
1658327brexpiprazole 0.5 MG Oral TabletPSN993b584c-7fe6-4551-899f-39146c8508ac4
1658331brexpiprazole 1 MG Oral TabletPSN993b584c-7fe6-4551-899f-39146c8508ac4
1658335brexpiprazole 2 MG Oral TabletPSN993b584c-7fe6-4551-899f-39146c8508ac4
1658339brexpiprazole 3 MG Oral TabletPSN993b584c-7fe6-4551-899f-39146c8508ac4
1658343brexpiprazole 4 MG Oral TabletPSN993b584c-7fe6-4551-899f-39146c8508ac4
1658319brexpiprazole 0.25 MG Oral TabletSCD993b584c-7fe6-4551-899f-39146c8508ac4
1658327brexpiprazole 0.5 MG Oral TabletSCD993b584c-7fe6-4551-899f-39146c8508ac4
1658331brexpiprazole 1 MG Oral TabletSCD993b584c-7fe6-4551-899f-39146c8508ac4
1658335brexpiprazole 2 MG Oral TabletSCD993b584c-7fe6-4551-899f-39146c8508ac4
1658339brexpiprazole 3 MG Oral TabletSCD993b584c-7fe6-4551-899f-39146c8508ac4
1658343brexpiprazole 4 MG Oral TabletSCD993b584c-7fe6-4551-899f-39146c8508ac4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
27241-207-302724102073030 TABLET in 1 BOTTLE (27241-207-30) 30 tablet2023-02-03NoNoCurrent