haloperidol

Generic: haloperidol

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

Drug Facts

Product Profile

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

haloperidol 10 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-3587
Product ID 70518-3587_47b83f45-171f-1d8c-e063-6394a90a7fc0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA071173
Listing Expiration 2027-12-31
Marketing Start 2022-12-05

Pharmacologic Class

Established (EPC)
typical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705183587
Hyphenated Format 70518-3587

Supplemental Identifiers

RxCUI
314035
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 ANDA071173 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BLISTER PACK (70518-3587-0)
  • 100 POUCH in 1 BOX (70518-3587-1) / 1 TABLET in 1 POUCH (70518-3587-2)
source: ndc

Packages (2)

70518-3587-0 30 TABLET in 1 BLISTER PACK (70518-3587-0) 70518-3587-1 100 POUCH in 1 BOX (70518-3587-1) / 1 TABLET in 1 POUCH (70518-3587-2)

Ingredients (1)

haloperidol (10 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": "47b83f45-171f-1d8c-e063-6394a90a7fc0", "openfda": {"nui": ["N0000180182"], "unii": ["J6292F8L3D"], "rxcui": ["314035"], "spl_set_id": ["a3afd19a-c340-4fad-8ddd-d71242515345"], "pharm_class_epc": ["Typical Antipsychotic [EPC]"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BLISTER PACK (70518-3587-0)", "package_ndc": "70518-3587-0", "marketing_start_date": "20221205"}, {"sample": false, "description": "100 POUCH in 1 BOX (70518-3587-1)  / 1 TABLET in 1 POUCH (70518-3587-2)", "package_ndc": "70518-3587-1", "marketing_start_date": "20260105"}], "brand_name": "Haloperidol", "product_id": "70518-3587_47b83f45-171f-1d8c-e063-6394a90a7fc0", "dosage_form": "TABLET", "pharm_class": ["Typical Antipsychotic [EPC]"], "product_ndc": "70518-3587", "generic_name": "Haloperidol", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Haloperidol", "active_ingredients": [{"name": "HALOPERIDOL", "strength": "10 mg/1"}], "application_number": "ANDA071173", "marketing_category": "ANDA", "marketing_start_date": "20221205", "listing_expiration_date": "20271231"}