haloperidol

Generic: haloperidol

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

Drug Facts

Product Profile

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

haloperidol 20 mg/1

Manufacturer
Marlex Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 10135-757
Product ID 10135-757_23e5e8d5-bddd-f9a9-e063-6394a90adb0c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA071173
Listing Expiration 2026-12-31
Marketing Start 2022-08-01

Pharmacologic Class

Established (EPC)
typical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 10135757
Hyphenated Format 10135-757

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 ANDA071173 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (10135-757-01)
  • 1000 TABLET in 1 BOTTLE (10135-757-10)
source: ndc

Packages (2)

10135-757-01 100 TABLET in 1 BOTTLE (10135-757-01) 10135-757-10 1000 TABLET in 1 BOTTLE (10135-757-10)

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": "23e5e8d5-bddd-f9a9-e063-6394a90adb0c", "openfda": {"nui": ["N0000180182"], "unii": ["J6292F8L3D"], "rxcui": ["197754", "310670", "310671", "310672", "314034", "314035"], "spl_set_id": ["e7a61604-741f-2d3b-e053-2995a90a62fc"], "pharm_class_epc": ["Typical Antipsychotic [EPC]"], "manufacturer_name": ["Marlex Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (10135-757-01)", "package_ndc": "10135-757-01", "marketing_start_date": "20220801"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (10135-757-10)", "package_ndc": "10135-757-10", "marketing_start_date": "20220801"}], "brand_name": "Haloperidol", "product_id": "10135-757_23e5e8d5-bddd-f9a9-e063-6394a90adb0c", "dosage_form": "TABLET", "pharm_class": ["Typical Antipsychotic [EPC]"], "product_ndc": "10135-757", "generic_name": "Haloperidol", "labeler_name": "Marlex Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Haloperidol", "active_ingredients": [{"name": "HALOPERIDOL", "strength": "20 mg/1"}], "application_number": "ANDA071173", "marketing_category": "ANDA", "marketing_start_date": "20220801", "listing_expiration_date": "20261231"}