Home NDC 59148-035 Rexulti
Product NDC 59148-035
11-digit product format 591480035
Labeler code 59148
Product ID 59148-035_3a208135-0d99-4d6a-b73e-61d63cf48f4f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name brexpiprazole
Dosage form TABLET
Route ORAL
Labeler Otsuka America Pharmaceutical, Inc.
Application NDA205422
Marketing category NDA
Marketing start 2015-07-10
Substance BREXPIPRAZOLE
Active strength .25 mg/1
Pharmacologic classes Atypical Antipsychotic [EPC]
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 · 6 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N205422-001 REXULTI BREXPIPRAZOLE 0.25MG TABLET / ORAL AB RLD 2015-07-10 N205422-002 REXULTI BREXPIPRAZOLE 0.5MG TABLET / ORAL AB RLD 2015-07-10 N205422-003 REXULTI BREXPIPRAZOLE 1MG TABLET / ORAL AB RLD 2015-07-10 N205422-004 REXULTI BREXPIPRAZOLE 2MG TABLET / ORAL AB RLD, RS 2015-07-10 N205422-005 REXULTI BREXPIPRAZOLE 3MG TABLET / ORAL AB RLD 2015-07-10 N205422-006 REXULTI BREXPIPRAZOLE 4MG TABLET / ORAL AB RLD 2015-07-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 6 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 76 matching rows.
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 30 matching rows.
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 7 · 246 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 N205422-001 REXULTI 0.25MG TABLET / ORAL AB RLD 2015-07-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205422-002 REXULTI 0.5MG TABLET / ORAL AB RLD 2015-07-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205422-003 REXULTI 1MG TABLET / ORAL AB RLD 2015-07-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205422-004 REXULTI 2MG TABLET / ORAL AB RLD, RS 2015-07-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205422-005 REXULTI 3MG TABLET / ORAL AB RLD 2015-07-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205422-006 REXULTI 4MG TABLET / ORAL AB RLD 2015-07-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205422-001 REXULTI 0.25MG TABLET / ORAL AB RLD 2015-07-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205422-002 REXULTI 0.5MG TABLET / ORAL AB RLD 2015-07-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205422-003 REXULTI 1MG TABLET / ORAL AB RLD 2015-07-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205422-004 REXULTI 2MG TABLET / ORAL AB RLD, RS 2015-07-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205422-005 REXULTI 3MG TABLET / ORAL AB RLD 2015-07-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205422-006 REXULTI 4MG TABLET / ORAL AB RLD 2015-07-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205422-001 REXULTI 0.25MG TABLET / ORAL AB RLD 2015-07-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205422-002 REXULTI 0.5MG TABLET / ORAL AB RLD 2015-07-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205422-003 REXULTI 1MG TABLET / ORAL AB RLD 2015-07-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205422-004 REXULTI 2MG TABLET / ORAL AB RLD, RS 2015-07-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205422-005 REXULTI 3MG TABLET / ORAL AB RLD 2015-07-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205422-006 REXULTI 4MG TABLET / ORAL AB RLD 2015-07-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205422-001 REXULTI 0.25MG TABLET / ORAL AB RLD 2015-07-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205422-002 REXULTI 0.5MG TABLET / ORAL AB RLD 2015-07-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205422-003 REXULTI 1MG TABLET / ORAL AB RLD 2015-07-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205422-004 REXULTI 2MG TABLET / ORAL AB RLD, RS 2015-07-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205422-005 REXULTI 3MG TABLET / ORAL AB RLD 2015-07-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205422-006 REXULTI 4MG TABLET / ORAL AB RLD 2015-07-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205422-001 REXULTI 0.25MG TABLET / ORAL AB RLD 2015-07-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205422-002 REXULTI 0.5MG TABLET / ORAL AB RLD 2015-07-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205422-003 REXULTI 1MG TABLET / ORAL AB RLD 2015-07-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205422-004 REXULTI 2MG TABLET / ORAL AB RLD, RS 2015-07-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205422-005 REXULTI 3MG TABLET / ORAL AB RLD 2015-07-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205422-006 REXULTI 4MG TABLET / ORAL AB RLD 2015-07-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205422-001 REXULTI 0.25MG TABLET / ORAL RLD 2015-07-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205422-002 REXULTI 0.5MG TABLET / ORAL RLD 2015-07-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205422-003 REXULTI 1MG TABLET / ORAL RLD 2015-07-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205422-004 REXULTI 2MG TABLET / ORAL RLD, RS 2015-07-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205422-005 REXULTI 3MG TABLET / ORAL RLD 2015-07-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205422-006 REXULTI 4MG TABLET / ORAL RLD 2015-07-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205422-001 REXULTI 0.25MG TABLET / ORAL RLD 2015-07-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205422-002 REXULTI 0.5MG TABLET / ORAL RLD 2015-07-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205422-003 REXULTI 1MG TABLET / ORAL RLD 2015-07-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205422-004 REXULTI 2MG TABLET / ORAL RLD, RS 2015-07-10 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 132 observed states.
Observed Orange Book patent history# Patent history page 1 of 63 · 2,519 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N205422-001 7888362 2026-04-12 Drug substance, Delist requested 2015-07-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205422-001 8349840 2026-04-12 U-1529 Drug product 2015-07-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205422-001 8618109 2026-04-12 U-543 2015-07-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205422-001 8618109 2026-04-12 U-3281 2015-07-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205422-001 9839637 2026-04-12 U-1529 Drug product 2018-01-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205422-001 9839637 2026-04-12 U-3281 Drug product 2018-01-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205422-001 9839637 2026-04-12 U-543 Drug product 2018-01-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205422-001 7888362*PED 2026-10-12 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205422-001 8349840*PED 2026-10-12 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205422-001 8618109*PED 2026-10-12 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205422-001 9839637*PED 2026-10-12 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205422-001 RE48059 2028-12-23 Drug substance 2020-07-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205422-001 RE48059*PED 2029-06-23 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205422-001 10307419 2032-10-12 Drug product 2019-06-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205422-001 10307419*PED 2033-04-12 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205422-002 7888362 2026-04-12 Drug substance, Delist requested 2015-07-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205422-002 8349840 2026-04-12 U-1529 Drug product 2015-07-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205422-002 8618109 2026-04-12 U-543 2015-07-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205422-002 8618109 2026-04-12 U-3281 2015-07-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205422-002 9839637 2026-04-12 U-543 Drug product 2018-01-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205422-002 9839637 2026-04-12 U-1529 Drug product 2018-01-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205422-002 9839637 2026-04-12 U-3281 Drug product 2018-01-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205422-002 7888362*PED 2026-10-12 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205422-002 8349840*PED 2026-10-12 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205422-002 8618109*PED 2026-10-12 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205422-002 9839637*PED 2026-10-12 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205422-002 RE48059 2028-12-23 Drug substance 2020-07-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205422-002 RE48059*PED 2029-06-23 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205422-002 10307419 2032-10-12 Drug product 2019-06-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205422-002 10307419*PED 2033-04-12 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205422-003 7888362 2026-04-12 Drug substance, Delist requested 2015-07-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205422-003 8349840 2026-04-12 U-1529 Drug product 2015-07-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205422-003 8618109 2026-04-12 U-543 2015-07-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205422-003 8618109 2026-04-12 U-3281 2015-07-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205422-003 9839637 2026-04-12 U-1529 Drug product 2018-01-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205422-003 9839637 2026-04-12 U-543 Drug product 2018-01-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205422-003 9839637 2026-04-12 U-3281 Drug product 2018-01-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205422-003 7888362*PED 2026-10-12 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205422-003 8349840*PED 2026-10-12 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205422-003 8618109*PED 2026-10-12 Pediatric extension 011fe1cb6892…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 16 · 612 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Rexulti
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BREXPIPRAZOLE .25 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 · 12 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1658319 Internal RxNorm lookup 1658325 Internal RxNorm lookup 1658327 Internal RxNorm lookup 1658329 Internal RxNorm lookup 1658331 Internal RxNorm lookup 1658333 Internal RxNorm lookup 1658335 Internal RxNorm lookup 1658337 Internal RxNorm lookup 1658339 Internal RxNorm lookup 1658341 Internal RxNorm lookup 1658343 Internal RxNorm lookup 1658345 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 59148-035-13 Rexulti 30 in 1 BOTTLE TABLET 30 26 59148-035-13 Rexulti 1 in 1 CARTON TABLET 1 26
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded brexpiprazole ACTIVE INGREDIENT 2J3YBM1K8C REXULTI (BREXPIPRAZOLE) TABLET [OTSUKA AMERICA PHARMACEUTICAL, INC.] 2 brexpiprazole ACTIVE MOIETY 2J3YBM1K8C REXULTI (BREXPIPRAZOLE) TABLET [OTSUKA AMERICA PHARMACEUTICAL, INC.] 2 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U REXULTI (BREXPIPRAZOLE) TABLET [OTSUKA AMERICA PHARMACEUTICAL, INC.] 2 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 REXULTI (BREXPIPRAZOLE) TABLET [OTSUKA AMERICA PHARMACEUTICAL, INC.] 2 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT REXULTI (BREXPIPRAZOLE) TABLET [OTSUKA AMERICA PHARMACEUTICAL, INC.] 2 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 REXULTI (BREXPIPRAZOLE) TABLET [OTSUKA AMERICA PHARMACEUTICAL, INC.] 2 hydroxypropyl cellulose (type h) INACTIVE INGREDIENT RFW2ET671P REXULTI (BREXPIPRAZOLE) TABLET [OTSUKA AMERICA PHARMACEUTICAL, INC.] 2 hydroxypropyl cellulose, low substituted INACTIVE INGREDIENT 2165RE0K14 REXULTI (BREXPIPRAZOLE) TABLET [OTSUKA AMERICA PHARMACEUTICAL, INC.] 2 hypromelloses INACTIVE INGREDIENT 3NXW29V3WO REXULTI (BREXPIPRAZOLE) TABLET [OTSUKA AMERICA PHARMACEUTICAL, INC.] 2 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X REXULTI (BREXPIPRAZOLE) TABLET [OTSUKA AMERICA PHARMACEUTICAL, INC.] 2 magnesium stearate INACTIVE INGREDIENT 70097M6I30 REXULTI (BREXPIPRAZOLE) TABLET [OTSUKA AMERICA PHARMACEUTICAL, INC.] 2 starch, corn INACTIVE INGREDIENT O8232NY3SJ REXULTI (BREXPIPRAZOLE) TABLET [OTSUKA AMERICA PHARMACEUTICAL, INC.] 2 talc INACTIVE INGREDIENT 7SEV7J4R1U REXULTI (BREXPIPRAZOLE) TABLET [OTSUKA AMERICA PHARMACEUTICAL, INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP REXULTI (BREXPIPRAZOLE) TABLET [OTSUKA AMERICA PHARMACEUTICAL, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59148-035 REXULTI (BREXPIPRAZOLE) TABLET REXULTI (BREXPIPRAZOLE) KIT [OTSUKA AMERICA PHARMACEUTICAL, INC.] 24 Current NDC, Legacy NDC, 2 package rows 20250519_2d301358-6291-4ec1-bd87-37b4ad9bd850.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 59148-035-13 59148003513 1 BOTTLE in 1 CARTON (59148-035-13) / 30 TABLET in 1 BOTTLE 1 bottle 2015-07-10 0000-00-00 No No Current