haldol decanoate

Generic: haloperidol decanoate

Labeler: janssen pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name haldol decanoate
Generic Name haloperidol decanoate
Labeler janssen pharmaceuticals, inc.
Dosage Form INJECTION
Routes
INTRAMUSCULAR
Active Ingredients

haloperidol decanoate 100 mg/mL

Manufacturer
Janssen Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 50458-254
Product ID 50458-254_43588a6b-8b38-dcaa-e063-6294a90a1666
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA018701
Marketing Start 1986-01-14
Marketing End 2027-08-31

Pharmacologic Class

Classes
typical antipsychotic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50458254
Hyphenated Format 50458-254

Supplemental Identifiers

RxCUI
1719803 1719847 1719862 1720026
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 haldol decanoate (source: ndc)
Generic Name haloperidol decanoate (source: ndc)
Application Number NDA018701 (source: ndc)
Routes
INTRAMUSCULAR
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 5 AMPULE in 1 BOX (50458-254-14) / 1 mL in 1 AMPULE
source: ndc

Packages (1)

50458-254-14 5 AMPULE in 1 BOX (50458-254-14) / 1 mL in 1 AMPULE

Ingredients (1)

haloperidol decanoate (100 mg/mL)

Linked Drug Pages (1)

Haldol Decanoate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR"], "spl_id": "43588a6b-8b38-dcaa-e063-6294a90a1666", "openfda": {"unii": ["AC20PJ4101"], "rxcui": ["1719803", "1719847", "1719862", "1720026"], "spl_set_id": ["af0159a8-dff5-449a-aa2b-a0c430081e21"], "manufacturer_name": ["Janssen Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 AMPULE in 1 BOX (50458-254-14)  / 1 mL in 1 AMPULE", "package_ndc": "50458-254-14", "marketing_end_date": "20270831", "marketing_start_date": "19860114"}], "brand_name": "Haldol Decanoate", "product_id": "50458-254_43588a6b-8b38-dcaa-e063-6294a90a1666", "dosage_form": "INJECTION", "pharm_class": ["Typical Antipsychotic [EPC]"], "product_ndc": "50458-254", "generic_name": "Haloperidol Decanoate", "labeler_name": "Janssen Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Haldol Decanoate", "active_ingredients": [{"name": "HALOPERIDOL DECANOATE", "strength": "100 mg/mL"}], "application_number": "NDA018701", "marketing_category": "NDA", "marketing_end_date": "20270831", "marketing_start_date": "19860114"}