brexpiprazole

Generic: brexpiprazole

Labeler: ajanta pharma usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name brexpiprazole
Generic Name brexpiprazole
Labeler ajanta pharma usa inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

brexpiprazole 4 mg/1

Manufacturer
Ajanta Pharma USA Inc.

Identifiers & Regulatory

Product NDC 27241-209
Product ID 27241-209_430dc8c4-7349-42d5-9036-b0bdcc02a839
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213718
Listing Expiration 2026-12-31
Marketing Start 2023-02-03

Pharmacologic Class

Established (EPC)
atypical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 27241209
Hyphenated Format 27241-209

Supplemental Identifiers

RxCUI
1658319 1658327 1658331 1658335 1658339 1658343
UPC
0327241205309 0327241208300 0327241209307 0327241206306 0327241207303 0327241204302
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 brexpiprazole (source: ndc)
Generic Name brexpiprazole (source: ndc)
Application Number ANDA213718 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (27241-209-30)
source: ndc

Packages (1)

27241-209-30 30 TABLET in 1 BOTTLE (27241-209-30)

Ingredients (1)

brexpiprazole (4 mg/1)

Linked Drug Pages (1)

Brexpiprazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "430dc8c4-7349-42d5-9036-b0bdcc02a839", "openfda": {"nui": ["N0000175430"], "upc": ["0327241205309", "0327241208300", "0327241209307", "0327241206306", "0327241207303", "0327241204302"], "unii": ["2J3YBM1K8C"], "rxcui": ["1658319", "1658327", "1658331", "1658335", "1658339", "1658343"], "spl_set_id": ["993b584c-7fe6-4551-899f-39146c8508ac"], "pharm_class_epc": ["Atypical Antipsychotic [EPC]"], "manufacturer_name": ["Ajanta Pharma USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (27241-209-30)", "package_ndc": "27241-209-30", "marketing_start_date": "20230203"}], "brand_name": "Brexpiprazole", "product_id": "27241-209_430dc8c4-7349-42d5-9036-b0bdcc02a839", "dosage_form": "TABLET", "pharm_class": ["Atypical Antipsychotic [EPC]"], "product_ndc": "27241-209", "generic_name": "Brexpiprazole", "labeler_name": "Ajanta Pharma USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Brexpiprazole", "active_ingredients": [{"name": "BREXPIPRAZOLE", "strength": "4 mg/1"}], "application_number": "ANDA213718", "marketing_category": "ANDA", "marketing_start_date": "20230203", "listing_expiration_date": "20261231"}