haloperidol

Generic: haloperidol

Labeler: zydus pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name haloperidol
Generic Name haloperidol
Labeler zydus pharmaceuticals usa inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

haloperidol 5 mg/1

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 68382-079
Product ID 68382-079_8d46c061-97af-4b2c-a788-bb08031d2c6f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077580
Listing Expiration 2026-12-31
Marketing Start 2008-01-03

Pharmacologic Class

Established (EPC)
typical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68382079
Hyphenated Format 68382-079

Supplemental Identifiers

RxCUI
197754 310670 310671 310672 314034 314035
UPC
0368382409010 0368382080011 0368382408013
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 ANDA077580 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (68382-079-01)
  • 1000 TABLET in 1 BOTTLE (68382-079-10)
source: ndc

Packages (2)

68382-079-01 100 TABLET in 1 BOTTLE (68382-079-01) 68382-079-10 1000 TABLET in 1 BOTTLE (68382-079-10)

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": "8d46c061-97af-4b2c-a788-bb08031d2c6f", "openfda": {"nui": ["N0000180182"], "upc": ["0368382409010", "0368382080011", "0368382408013"], "unii": ["J6292F8L3D"], "rxcui": ["197754", "310670", "310671", "310672", "314034", "314035"], "spl_set_id": ["54502f78-7244-454a-9171-4e73127f1456"], "pharm_class_epc": ["Typical Antipsychotic [EPC]"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (68382-079-01)", "package_ndc": "68382-079-01", "marketing_start_date": "20080103"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (68382-079-10)", "package_ndc": "68382-079-10", "marketing_start_date": "20080103"}], "brand_name": "Haloperidol", "product_id": "68382-079_8d46c061-97af-4b2c-a788-bb08031d2c6f", "dosage_form": "TABLET", "pharm_class": ["Typical Antipsychotic [EPC]"], "product_ndc": "68382-079", "generic_name": "Haloperidol", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Haloperidol", "active_ingredients": [{"name": "HALOPERIDOL", "strength": "5 mg/1"}], "application_number": "ANDA077580", "marketing_category": "ANDA", "marketing_start_date": "20080103", "listing_expiration_date": "20261231"}