haloperidol

Generic: haloperidol

Labeler: coupler llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name haloperidol
Generic Name haloperidol
Labeler coupler llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

haloperidol 5 mg/1

Manufacturer
Coupler LLC

Identifiers & Regulatory

Product NDC 67046-1603
Product ID 67046-1603_40187e11-e94a-e759-e063-6394a90a4840
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218789
Listing Expiration 2026-12-31
Marketing Start 2025-10-01

Pharmacologic Class

Established (EPC)
typical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 670461603
Hyphenated Format 67046-1603

Supplemental Identifiers

RxCUI
310672
UNII
J6292F8L3D
NUI
N0000180182

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 ANDA218789 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BLISTER PACK (67046-1603-3)
source: ndc

Packages (1)

67046-1603-3 30 TABLET in 1 BLISTER PACK (67046-1603-3)

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": "40187e11-e94a-e759-e063-6394a90a4840", "openfda": {"nui": ["N0000180182"], "unii": ["J6292F8L3D"], "rxcui": ["310672"], "spl_set_id": ["40187e83-1144-db0e-e063-6394a90a42df"], "pharm_class_epc": ["Typical Antipsychotic [EPC]"], "manufacturer_name": ["Coupler LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BLISTER PACK (67046-1603-3)", "package_ndc": "67046-1603-3", "marketing_start_date": "20251001"}], "brand_name": "Haloperidol", "product_id": "67046-1603_40187e11-e94a-e759-e063-6394a90a4840", "dosage_form": "TABLET", "pharm_class": ["Typical Antipsychotic [EPC]"], "product_ndc": "67046-1603", "generic_name": "Haloperidol", "labeler_name": "Coupler LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Haloperidol", "active_ingredients": [{"name": "HALOPERIDOL", "strength": "5 mg/1"}], "application_number": "ANDA218789", "marketing_category": "ANDA", "marketing_start_date": "20251001", "listing_expiration_date": "20261231"}