haloperidol

Generic: haloperidol

Labeler: pai holdings, llc dba pai pharma
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name haloperidol
Generic Name haloperidol
Labeler pai holdings, llc dba pai pharma
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

haloperidol 2 mg/mL

Manufacturer
PAI Holdings, LLC dba PAI Pharma

Identifiers & Regulatory

Product NDC 0121-0581
Product ID 0121-0581_0f6d8b89-8c33-4459-84af-e588eb27587c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA073037
Listing Expiration 2026-12-31
Marketing Start 2009-11-10

Pharmacologic Class

Established (EPC)
typical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01210581
Hyphenated Format 0121-0581

Supplemental Identifiers

RxCUI
141935
UPC
0301210581045 0301210581151
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 ANDA073037 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 120 mL in 1 BOTTLE (0121-0581-04)
  • 10 TRAY in 1 CASE (0121-0581-05) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE
  • 15 mL in 1 BOTTLE (0121-0581-15)
source: ndc

Packages (3)

0121-0581-04 120 mL in 1 BOTTLE (0121-0581-04) 0121-0581-05 10 TRAY in 1 CASE (0121-0581-05) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE 0121-0581-15 15 mL in 1 BOTTLE (0121-0581-15)

Ingredients (1)

haloperidol (2 mg/mL)

Linked Drug Pages (1)

Haloperidol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0f6d8b89-8c33-4459-84af-e588eb27587c", "openfda": {"nui": ["N0000180182"], "upc": ["0301210581045", "0301210581151"], "unii": ["J6292F8L3D"], "rxcui": ["141935"], "spl_set_id": ["b488c106-f1ee-4b7b-8516-01162fb929f7"], "pharm_class_epc": ["Typical Antipsychotic [EPC]"], "manufacturer_name": ["PAI Holdings, LLC dba PAI Pharma"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 mL in 1 BOTTLE (0121-0581-04)", "package_ndc": "0121-0581-04", "marketing_start_date": "20091110"}, {"sample": false, "description": "10 TRAY in 1 CASE (0121-0581-05)  / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE", "package_ndc": "0121-0581-05", "marketing_start_date": "20091110"}, {"sample": false, "description": "15 mL in 1 BOTTLE (0121-0581-15)", "package_ndc": "0121-0581-15", "marketing_start_date": "20200612"}], "brand_name": "Haloperidol", "product_id": "0121-0581_0f6d8b89-8c33-4459-84af-e588eb27587c", "dosage_form": "SOLUTION", "pharm_class": ["Typical Antipsychotic [EPC]"], "product_ndc": "0121-0581", "generic_name": "Haloperidol", "labeler_name": "PAI Holdings, LLC dba PAI Pharma", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Haloperidol", "active_ingredients": [{"name": "HALOPERIDOL", "strength": "2 mg/mL"}], "application_number": "ANDA073037", "marketing_category": "ANDA", "marketing_start_date": "20091110", "listing_expiration_date": "20261231"}