rexulti

Generic: brexpiprazole

Labeler: otsuka america pharmaceutical, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name rexulti
Generic Name brexpiprazole
Labeler otsuka america pharmaceutical, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

brexpiprazole 4 mg/1

Manufacturer
Otsuka America Pharmaceutical, Inc.

Identifiers & Regulatory

Product NDC 59148-040
Product ID 59148-040_6507f292-90e7-408c-baf5-4475fc31a06d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA205422
Listing Expiration 2026-12-31
Marketing Start 2015-07-10

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59148040
Hyphenated Format 59148-040

Supplemental Identifiers

RxCUI
1658319 1658325 1658327 1658329 1658331 1658333 1658335 1658337 1658339 1658341 1658343 1658345
UPC
0359148035130 0359148040134 0359148036137 0359148038131 0359148039138 0359148037134
UNII
2J3YBM1K8C
NUI
N0000175430

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name rexulti (source: ndc)
Generic Name brexpiprazole (source: ndc)
Application Number NDA205422 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (59148-040-07) / 7 TABLET in 1 BLISTER PACK
  • 1 BOTTLE in 1 CARTON (59148-040-13) / 30 TABLET in 1 BOTTLE
source: ndc

Packages (2)

59148-040-07 1 BLISTER PACK in 1 CARTON (59148-040-07) / 7 TABLET in 1 BLISTER PACK 59148-040-13 1 BOTTLE in 1 CARTON (59148-040-13) / 30 TABLET in 1 BOTTLE

Ingredients (1)

brexpiprazole (4 mg/1)

Linked Drug Pages (1)

Rexulti ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "6507f292-90e7-408c-baf5-4475fc31a06d", "openfda": {"nui": ["N0000175430"], "upc": ["0359148035130", "0359148040134", "0359148036137", "0359148038131", "0359148039138", "0359148037134"], "unii": ["2J3YBM1K8C"], "rxcui": ["1658319", "1658325", "1658327", "1658329", "1658331", "1658333", "1658335", "1658337", "1658339", "1658341", "1658343", "1658345"], "spl_set_id": ["2d301358-6291-4ec1-bd87-37b4ad9bd850"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Otsuka America Pharmaceutical, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "1 BLISTER PACK in 1 CARTON (59148-040-07)  / 7 TABLET in 1 BLISTER PACK", "package_ndc": "59148-040-07", "marketing_start_date": "20150710"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (59148-040-13)  / 30 TABLET in 1 BOTTLE", "package_ndc": "59148-040-13", "marketing_start_date": "20150710"}], "brand_name": "Rexulti", "product_id": "59148-040_6507f292-90e7-408c-baf5-4475fc31a06d", "dosage_form": "TABLET", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "59148-040", "generic_name": "brexpiprazole", "labeler_name": "Otsuka America Pharmaceutical, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Rexulti", "active_ingredients": [{"name": "BREXPIPRAZOLE", "strength": "4 mg/1"}], "application_number": "NDA205422", "marketing_category": "NDA", "marketing_start_date": "20150710", "listing_expiration_date": "20261231"}