haloperidol

Generic: haloperidol

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name haloperidol
Generic Name haloperidol
Labeler aurobindo pharma limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

haloperidol 5 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-792
Product ID 59651-792_265a70c4-9b29-464c-9258-735bd2b2ccf7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218789
Listing Expiration 2026-12-31
Marketing Start 2024-04-19

Pharmacologic Class

Established (EPC)
typical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59651792
Hyphenated Format 59651-792

Supplemental Identifiers

RxCUI
197754 310670 310671 310672 314034 314035
UNII
J6292F8L3D
NUI
N0000180182

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 haloperidol (source: ndc)
Generic Name haloperidol (source: ndc)
Application Number ANDA218789 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (59651-792-01)
  • 1000 TABLET in 1 BOTTLE (59651-792-99)
source: ndc

Packages (2)

59651-792-01 100 TABLET in 1 BOTTLE (59651-792-01) 59651-792-99 1000 TABLET in 1 BOTTLE (59651-792-99)

Ingredients (1)

haloperidol (5 mg/1)

Linked Drug Pages (1)

Haloperidol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "265a70c4-9b29-464c-9258-735bd2b2ccf7", "openfda": {"nui": ["N0000180182"], "unii": ["J6292F8L3D"], "rxcui": ["197754", "310670", "310671", "310672", "314034", "314035"], "spl_set_id": ["bf21633e-f37b-4017-a143-538eb005de2d"], "pharm_class_epc": ["Typical Antipsychotic [EPC]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (59651-792-01)", "package_ndc": "59651-792-01", "marketing_start_date": "20240419"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (59651-792-99)", "package_ndc": "59651-792-99", "marketing_start_date": "20240419"}], "brand_name": "Haloperidol", "product_id": "59651-792_265a70c4-9b29-464c-9258-735bd2b2ccf7", "dosage_form": "TABLET", "pharm_class": ["Typical Antipsychotic [EPC]"], "product_ndc": "59651-792", "generic_name": "Haloperidol", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Haloperidol", "active_ingredients": [{"name": "HALOPERIDOL", "strength": "5 mg/1"}], "application_number": "ANDA218789", "marketing_category": "ANDA", "marketing_start_date": "20240419", "listing_expiration_date": "20261231"}