haloperidol

Generic: haloperidol

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

Drug Facts

Product Profile

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

haloperidol 20 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-0335
Product ID 0378-0335_1b33ae94-4fa5-4298-a713-3e049c47588c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA070278
Marketing Start 2009-07-17
Marketing End 2026-03-31

Pharmacologic Class

Established (EPC)
typical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03780335
Hyphenated Format 0378-0335

Supplemental Identifiers

RxCUI
197754 310670 310671 310672 314034 314035
UPC
0303780351011
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 ANDA070278 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (0378-0335-01)
source: ndc

Packages (1)

0378-0335-01 100 TABLET in 1 BOTTLE, PLASTIC (0378-0335-01)

Ingredients (1)

haloperidol (20 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": "1b33ae94-4fa5-4298-a713-3e049c47588c", "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 (0378-0335-01)", "package_ndc": "0378-0335-01", "marketing_end_date": "20260331", "marketing_start_date": "20090717"}], "brand_name": "Haloperidol", "product_id": "0378-0335_1b33ae94-4fa5-4298-a713-3e049c47588c", "dosage_form": "TABLET", "pharm_class": ["Typical Antipsychotic [EPC]"], "product_ndc": "0378-0335", "generic_name": "haloperidol", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Haloperidol", "active_ingredients": [{"name": "HALOPERIDOL", "strength": "20 mg/1"}], "application_number": "ANDA070278", "marketing_category": "ANDA", "marketing_end_date": "20260331", "marketing_start_date": "20090717"}