Home NDC 27241-206 Brexpiprazole
Product NDC 27241-206
11-digit product format 272410206
Labeler code 27241
Product ID 27241-206_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 1 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A213718-001 BREXPIPRAZOLE BREXPIPRAZOLE 0.25MG TABLET / ORAL 2023-02-03 A213718-002 BREXPIPRAZOLE BREXPIPRAZOLE 0.5MG TABLET / ORAL 2023-02-03 A213718-003 BREXPIPRAZOLE BREXPIPRAZOLE 1MG TABLET / ORAL 2023-02-03 A213718-004 BREXPIPRAZOLE BREXPIPRAZOLE 2MG TABLET / ORAL 2023-02-03 A213718-005 BREXPIPRAZOLE BREXPIPRAZOLE 3MG TABLET / ORAL 2023-02-03 A213718-006 BREXPIPRAZOLE BREXPIPRAZOLE 4MG TABLET / ORAL 2023-02-03
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A213718-001 BREXPIPRAZOLE 0.25MG TABLET / ORAL 2023-02-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213718-002 BREXPIPRAZOLE 0.5MG TABLET / ORAL 2023-02-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213718-003 BREXPIPRAZOLE 1MG TABLET / ORAL 2023-02-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213718-004 BREXPIPRAZOLE 2MG TABLET / ORAL 2023-02-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213718-005 BREXPIPRAZOLE 3MG TABLET / ORAL 2023-02-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213718-006 BREXPIPRAZOLE 4MG TABLET / ORAL 2023-02-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213718-001 BREXPIPRAZOLE 0.25MG TABLET / ORAL 2023-02-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213718-002 BREXPIPRAZOLE 0.5MG TABLET / ORAL 2023-02-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213718-003 BREXPIPRAZOLE 1MG TABLET / ORAL 2023-02-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213718-004 BREXPIPRAZOLE 2MG TABLET / ORAL 2023-02-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213718-005 BREXPIPRAZOLE 3MG TABLET / ORAL 2023-02-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213718-006 BREXPIPRAZOLE 4MG TABLET / ORAL 2023-02-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213718-001 BREXPIPRAZOLE 0.25MG TABLET / ORAL 2023-02-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213718-002 BREXPIPRAZOLE 0.5MG TABLET / ORAL 2023-02-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213718-003 BREXPIPRAZOLE 1MG TABLET / ORAL 2023-02-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213718-004 BREXPIPRAZOLE 2MG TABLET / ORAL 2023-02-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213718-005 BREXPIPRAZOLE 3MG TABLET / ORAL 2023-02-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213718-006 BREXPIPRAZOLE 4MG TABLET / ORAL 2023-02-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213718-001 BREXPIPRAZOLE 0.25MG TABLET / ORAL 2023-02-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213718-002 BREXPIPRAZOLE 0.5MG TABLET / ORAL 2023-02-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213718-003 BREXPIPRAZOLE 1MG TABLET / ORAL 2023-02-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213718-004 BREXPIPRAZOLE 2MG TABLET / ORAL 2023-02-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213718-005 BREXPIPRAZOLE 3MG TABLET / ORAL 2023-02-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213718-006 BREXPIPRAZOLE 4MG TABLET / ORAL 2023-02-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213718-001 BREXPIPRAZOLE 0.25MG TABLET / ORAL 2023-02-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213718-002 BREXPIPRAZOLE 0.5MG TABLET / ORAL 2023-02-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213718-003 BREXPIPRAZOLE 1MG TABLET / ORAL 2023-02-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213718-004 BREXPIPRAZOLE 2MG TABLET / ORAL 2023-02-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213718-005 BREXPIPRAZOLE 3MG TABLET / ORAL 2023-02-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213718-006 BREXPIPRAZOLE 4MG TABLET / ORAL 2023-02-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213718-001 BREXPIPRAZOLE 0.25MG TABLET / ORAL 2023-02-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213718-002 BREXPIPRAZOLE 0.5MG TABLET / ORAL 2023-02-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213718-003 BREXPIPRAZOLE 1MG TABLET / ORAL 2023-02-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213718-004 BREXPIPRAZOLE 2MG TABLET / ORAL 2023-02-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213718-005 BREXPIPRAZOLE 3MG TABLET / ORAL 2023-02-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213718-006 BREXPIPRAZOLE 4MG TABLET / ORAL 2023-02-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213718-001 BREXPIPRAZOLE 0.25MG TABLET / ORAL 2023-02-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213718-002 BREXPIPRAZOLE 0.5MG TABLET / ORAL 2023-02-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213718-003 BREXPIPRAZOLE 1MG TABLET / ORAL 2023-02-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213718-004 BREXPIPRAZOLE 2MG TABLET / ORAL 2023-02-03 2680178bc6a6…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Brexpiprazole
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BREXPIPRAZOLE 1 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2J3YBM1K8C Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1658319 Internal RxNorm lookup 1658327 Internal RxNorm lookup 1658331 Internal RxNorm lookup 1658335 Internal RxNorm lookup 1658339 Internal RxNorm lookup 1658343 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 27241-206-30 Brexpiprazole 30 in 1 BOTTLE TABLET 30 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 27241-206 BREXPIPRAZOLE TABLET [AJANTA PHARMA USA INC.] 4 Current NDC, 1 package rows 20230222_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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 27241-206-30 27241020630 30 TABLET in 1 BOTTLE (27241-206-30) 30 tablet 2023-02-03 No No Current