haloperidol decanoate

Generic: haloperidol decanoate

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name haloperidol decanoate
Generic Name haloperidol decanoate
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION
Routes
INTRAMUSCULAR
Active Ingredients

haloperidol decanoate 100 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9296
Product ID 0143-9296_4d57ff6f-2f61-49f5-95d7-cbfa3505f020
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075305
Listing Expiration 2026-12-31
Marketing Start 1998-10-01

Pharmacologic Class

Classes
typical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01439296
Hyphenated Format 0143-9296

Supplemental Identifiers

RxCUI
859871 1719803
UNII
AC20PJ4101

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 decanoate (source: ndc)
Generic Name haloperidol decanoate (source: ndc)
Application Number ANDA075305 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 BOX (0143-9296-01) / 5 mL in 1 VIAL
source: ndc

Packages (1)

Ingredients (1)

haloperidol decanoate (100 mg/mL)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["INTRAMUSCULAR"], "spl_id": "4d57ff6f-2f61-49f5-95d7-cbfa3505f020", "openfda": {"unii": ["AC20PJ4101"], "rxcui": ["859871", "1719803"], "spl_set_id": ["914026da-103a-4466-abd5-3763e9d55b67"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 BOX (0143-9296-01)  / 5 mL in 1 VIAL", "package_ndc": "0143-9296-01", "marketing_start_date": "19981001"}], "brand_name": "Haloperidol Decanoate", "product_id": "0143-9296_4d57ff6f-2f61-49f5-95d7-cbfa3505f020", "dosage_form": "INJECTION", "pharm_class": ["Typical Antipsychotic [EPC]"], "product_ndc": "0143-9296", "generic_name": "Haloperidol Decanoate", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Haloperidol Decanoate", "active_ingredients": [{"name": "HALOPERIDOL DECANOATE", "strength": "100 mg/mL"}], "application_number": "ANDA075305", "marketing_category": "ANDA", "marketing_start_date": "19981001", "listing_expiration_date": "20261231"}