Haloperidol

Generic: haloperidol

Labeler: Mylan Pharmaceuticals Inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Active

Drug Facts

Product Profile

Brand Name Haloperidol
Generic Name haloperidol
Labeler Mylan Pharmaceuticals Inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

HALOPERIDOL 5 mg/1

Identifiers & Regulatory

Product NDC 0378-0327
Product ID 0378-0327_6c9cb993-d2d8-4c2a-b425-1ce8867c970c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA070278
Listing Expiration 2026-12-31
Marketing Start 1986-06-10

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03780327
Hyphenated Format 0378-0327

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 ANDA070278 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (0378-0327-01)
  • 1000 TABLET in 1 BOTTLE, PLASTIC (0378-0327-10)
source: ndc

Packages (2)

0378-0327-01 100 TABLET in 1 BOTTLE, PLASTIC (0378-0327-01) 0378-0327-10 1000 TABLET in 1 BOTTLE, PLASTIC (0378-0327-10)

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": "6c9cb993-d2d8-4c2a-b425-1ce8867c970c", "openfda": {"nui": ["N0000180182"], "upc": ["0303780351011"], "unii": ["J6292F8L3D"], "rxcui": ["197754", "310670", "310671", "310672", "314034", "314035"], "spl_set_id": ["c559b0b0-4087-d12a-e718-c18ccb6811e6"], "pharm_class_epc": ["Typical Antipsychotic [EPC]"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (0378-0327-01)", "package_ndc": "0378-0327-01", "marketing_start_date": "19860610"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE, PLASTIC (0378-0327-10)", "package_ndc": "0378-0327-10", "marketing_start_date": "19860610"}], "brand_name": "Haloperidol", "product_id": "0378-0327_6c9cb993-d2d8-4c2a-b425-1ce8867c970c", "dosage_form": "TABLET", "pharm_class": ["Typical Antipsychotic [EPC]"], "product_ndc": "0378-0327", "generic_name": "haloperidol", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Haloperidol", "active_ingredients": [{"name": "HALOPERIDOL", "strength": "5 mg/1"}], "application_number": "ANDA070278", "marketing_category": "ANDA", "marketing_start_date": "19860610", "listing_expiration_date": "20261231"}