haloperidol

Generic: haloperidol

Labeler: zydus lifesciences limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name haloperidol
Generic Name haloperidol
Labeler zydus lifesciences limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

haloperidol 1 mg/1

Manufacturer
Zydus Lifesciences Limited

Identifiers & Regulatory

Product NDC 65841-838
Product ID 65841-838_2ff366f9-878f-4fcb-b2d4-00fb6e31ecbf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077580
Listing Expiration 2026-12-31
Marketing Start 2023-02-01

Pharmacologic Class

Established (EPC)
typical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65841838
Hyphenated Format 65841-838

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 ANDA077580 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (65841-838-01)
  • 1000 TABLET in 1 BOTTLE (65841-838-10)
  • 10 BLISTER PACK in 1 CARTON (65841-838-77) / 10 TABLET in 1 BLISTER PACK (65841-838-30)
source: ndc

Packages (3)

65841-838-01 100 TABLET in 1 BOTTLE (65841-838-01) 65841-838-10 1000 TABLET in 1 BOTTLE (65841-838-10) 65841-838-77 10 BLISTER PACK in 1 CARTON (65841-838-77) / 10 TABLET in 1 BLISTER PACK (65841-838-30)

Ingredients (1)

haloperidol (1 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": "2ff366f9-878f-4fcb-b2d4-00fb6e31ecbf", "openfda": {"nui": ["N0000180182"], "unii": ["J6292F8L3D"], "rxcui": ["197754", "310670", "310671", "310672", "314034", "314035"], "spl_set_id": ["509d0eb2-b930-4836-9669-dbebf0ac4076"], "pharm_class_epc": ["Typical Antipsychotic [EPC]"], "manufacturer_name": ["Zydus Lifesciences Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (65841-838-01)", "package_ndc": "65841-838-01", "marketing_start_date": "20230201"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (65841-838-10)", "package_ndc": "65841-838-10", "marketing_start_date": "20230201"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (65841-838-77)  / 10 TABLET in 1 BLISTER PACK (65841-838-30)", "package_ndc": "65841-838-77", "marketing_start_date": "20230201"}], "brand_name": "Haloperidol", "product_id": "65841-838_2ff366f9-878f-4fcb-b2d4-00fb6e31ecbf", "dosage_form": "TABLET", "pharm_class": ["Typical Antipsychotic [EPC]"], "product_ndc": "65841-838", "generic_name": "Haloperidol", "labeler_name": "Zydus Lifesciences Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Haloperidol", "active_ingredients": [{"name": "HALOPERIDOL", "strength": "1 mg/1"}], "application_number": "ANDA077580", "marketing_category": "ANDA", "marketing_start_date": "20230201", "listing_expiration_date": "20261231"}